Vaginal Atrophy
Conditions
Brief summary
A Phase 2, Dose-ranging, 12-week Randomized, Double-blind, Placebo controlled, Parallel-group Study Evaluating the Efficacy and Safety of Three Formulations of Ultra-low Dose Estriol Vaginal Gel (0.005% Estriol Vaginal Gel, 0.002% Estriol Vaginal Gel, 0.0008% Estriol Vaginal Gel) for the Treatment of Vaginal Dryness in Postmenopausal Women with Vulvovaginal Atrophy. Vulvovaginal atrophy is a natural consequence of the progressive estrogen deficiency that occurs in menopause. Epidemiological data have indicated that about 50% of otherwise healthy women over 60 years of age experience symptoms related to urogenital atrophy such as vaginal dryness, dyspareunia, burning, itching, as well as urinary complaints or infections of the lower urinary tract. As these alterations frequently affect the quality of life of postmenopausal women, it is important for doctors to detect their presence and offer treatment options. Estrogen therapy is the most effective treatment of moderate to severe symptoms of vulvar and vaginal atrophy. One advantage of local treatment with estrogen is avoidance of first-pass liver metabolism, making it possible to use lower doses of estrogen compared with oral therapy; the local route also minimize systemic adverse effects. The search for therapeutic alternatives which may present improvements in relation to the current products has been encouraged.
Interventions
DRUGEstriol
DRUGPlacebo
Sponsors
ITF Research Pharma, S.L.U.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Capable of understanding the written informed consent, provides signed and witnessed written informed consent, and agrees to comply with the protocol procedures and assessments 2. Age \>40 and \<80 years 3. Postmenopausal (≥12 months since last spontaneous menstrual period, or having 6 months of spontaneous amenorrhea with serum FSH levels \>40 IU/L, or ≥6 weeks since bilateral oophorectomy with or without hysterectomy) 4. BMI ≤36 kg/m2 5. Vaginal Maturation Index ≤ 5% superficial cells on a vaginal smear 6. Vaginal pH \>5 7. Moderate to severe vaginal dryness currently reported as the most bothersome symptom of vaginal atrophy. 8. Documented negative mammogram within 9 months prior to randomization, with normal breast examination at screening. 9. Negative Papanicolau test at screening (in women with cervix).
Exclusion criteria
1. Subjects with contraindications for hormone therapy with estrogens such as those diagnosed or history of: malignant and premalignant lesions of the breast and/or endometrium, malignancy of the colon, malignant melanoma, hepatic tumor, venous thromboembolic conditions (including deep vein thrombosis or pulmonary embolism), arterial thromboembolic conditions (including angina pectoris, myocardial infarction, or cerebrovascular accident), coagulopathies, vaginal bleeding of unknown etiology, acute liver disease or a history of liver disease as long as liver function tests have failed to return to normal, or porphyria. 2. Subjects who have abnormal laboratory values at screening that the investigator considers clinically relevant for the purposes of the study. 3. Subjects with any medical-surgical pathology which is not controlled at the time of inclusion in the study 4. Subjects with any acute or chronic condition whose management or progression may interfere with the subject´s participation in the study. 5. Subject with uncontrolled hypertension (\>140 mmHg systolic blood pressure and/or ≥90 mmHg diastolic blood pressure). 6. Subjects with Grade II or higher utero-vaginal prolapse. 7. Subjects with uterine polyps. 8. Subjects with symptomatic and/or large uterine fibroids (\>3 cm) and/or palpable fibroids at gynecological examination. 9. Subjects who have had urogenital surgery within 3 months of baseline visit. 10. Subjects with signs and symptoms suggestive of infection of the genital or urinary tract requiring treatment at the start of the study. 11. In women who have a uterus, evidence of hyperplasia, cancer or other endometrial pathology in endometrial biopsy. 12. Subjects who have received the following treatments within the specified time periods prior to screening procedures: any type of non-hormonal vulvovaginal treatment in the 7 days (including cosmetics expected to have an impact on vaginal pH such as special feminine wash gels); phytoestrogens by any route within 1 month; vaginal hormone therapy within 1 month; hormone therapy (estrogen alone, progestin alone or estrogen/progestin combination) by oral, intrauterine or transdermal route within 2 months; progestational implants, estrogen, or estrogen/progestational injectable within 3 months; estrogen pellet therapy or progestin injectable drug therapy within 6 months; percutaneous estrogen lotions or gels within 1 month; testosterone or testosterone derivatives, DHEA, tibolone, or SERMs by any route within 2 months; 13. Subjects receiving antiepileptic drugs (barbiturates, hydantoins, carbamazepine), certain antibiotics and other antiinfective medicinal products; phenylbutazone; preparations based on medicinal plants that contain St. John's Wort. 14. Subjects who are allergic to any of the components of the medication under study. 15. Subjects who are currently participating or have participated in the experimental evaluation of any product within 8 weeks of the start of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Week 12 in the Severity of Vaginal Dryness | From baseline to week 12 | Percentage of Subjects with change from baseline to week 12 in the severity of vaginal dryness was reported. Severity was defined as: 0= Absent, 1= Mild, 2= Moderate, 3= Severe. A decrease in score compared to Baseline represented a positive outcome. |
| Change From Baseline to Week 12 in Vaginal pH | Baseline to Week 12 | Change from Baseline to Week 12 in Vaginal pH was reported. A decrease in pH compare to Baseline represents a positive outcome. |
| Change From Baseline to Week 12 in the Proportion of Superficial Cells of the Vaginal Epithelium. | Baseline to Week 12 | Change from Baseline to week 12 in the proportion of superficial cells of the vaginal epithelium was reported. |
| Change From Baseline to Week 12 in the Proportion of Parabasal Cells of the Vaginal Epithelium. | Baseline to Week 12 | Change from Baseline to Week 12 in the proportion of parabasal cells of the vaginal epithelium was reported. A decrease in proportion of parabasal cells compared to Baseline represents a positive outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Week 12 in the Global Symptom Score 1 | Baseline to Week 12 | Global Symptom Score 1 was defined as the sum of all 5 individual symptom scores at a given visit, and was calculated only when all 5 symptom scores had a response available. the Global Symptom Score 1 ranged at Screening/Baseline between 2 (at least moderate vaginal dryness -per inclusion criteria) to 15 (all 5 studied symptoms severe in intensity). At Week 12/ET visit, the Global Symptom Score ranged between 0 (no symptoms) and 15 (all symptoms severe in intensity). A decrease in score compared to Baseline represented a positive outcome. |
| Change From Baseline to Week 12 in the Global Symptom Score 2 | Baseline to Week 12 | Change from Baseline to Week 12 in the Global Symptom Score 2 was reported. Global Symptom Score 2 was defined as the sum of all 4 individual symptoms excluding dyspareunia (vaginal dryness, pruritus or itching, burning, and dysuria) for each subject at each time point: Screening/Baseline, Week 3 and Week 12/ET., and was calculated only when all 4 symptom scores had a response available. The maximum score possible to be obtained at a visit with the Global Symptom Score 2 was 12 (all symptoms severe in intensity). A decrease in score compared to baseline represented a positive outcome. |
| Change From Baseline to Week 12 in the Severity of Pallor. | Baseline to Week 12 | Percentage of subjects with change from Baseline to Week 12 in the severity of pallor was reported. Sign scores at each visit: 0= Absent, 1= Mild, 2= Moderate, 3= Severe. A decrease in score compared to baseline represented a positive putcome. |
| Change From Baseline to Week 12 in the Severity of Friability | Baseline to Week 12 | Percentage of subjects with change from Baseline to Week 12 in the severity of friability was reported. Sign scores at each visit: 0= Absent, 1= Mild, 2= Moderate, 3= Severe. A decrease in score compared to baseline represented a positive outcome. |
| Change From Baseline to Week 12 in the Severity of Thinning or Flattening of Folds | Baseline to Week 12 | Percentage of subjects with change from Baseline to Week 12 in the severity of thinning or flattening of folds was reported. Sign scores at each visit: 0= Absent, 1= Mild, 2= Moderate, 3= Severe. A decrease in score compared to baseline represented a positive outcome. |
| Change From Baseline to Week 12 in the Severity of Petechiae | Baseline to Week 12 | Percentage of subjects with change from Baseline to Week 12 in the severity of presence of petechiae was reported. Sign scores at each visit: 0= Absent, 1= Mild, 2= Moderate, 3= Severe. A decrease in score compared to baseline represented a positive outcome. |
| Change From Baseline to Week 12 in the Severity of Dry Mucosa | Baseline to Week 12 | Percentage of subjects with change from Baseline to Week 12 in the severity of dry mucosa was reported. Sign scores at each visit: 0= Absent, 1= Mild, 2= Moderate, 3= Severe. A decrease in score compared to baseline represented a positive outcome. |
| Change From Baseline to Week 3 in the Severity of Vaginal Dryness | Baseline to Week 3 | Percentage of subjects with change from Baseline to Week 3 in the severity of vaginal dryness was reported. Severity was defined as: 0= Absent, 1= Mild, 2= Moderate, 3= Severe. A decrease in score compared to baseline represented a positive outcome. |
| Change From Baseline to Week 3 in the Severity of Dyspareunia | From baseline to week 3 | Percentage of subjects with change from Baseline to Week 3 in severity of dyspareunia was reported. Dyspareunia was only applicable in subjects who had experienced sexual activity with penetration since the previous study visit. Symptom scores at each visit: 0= Absent, 1= Mild, 2= Moderate, 3= Severe. A decrease in score compared to baseline represented a positive outcome. |
| Change From Baseline to Week 3 in the Severity of Pruritus or Itching | Baseline to Week 3 | Percentage of subjects with change from Baseline to Week 3 in the severity of pruritus or itching was reported. Symptom scores at each visit: 0= Absent, 1= Mild, 2= Moderate, 3= Severe. A decrease in score compared to baseline represented a positive outcome. |
| Change From Baseline to Week 3 in the Severity of Burning | Baseline to Week 3 | Percentage of subjects with change from Baseline to Week 3 in severity of burning was reported. Symptom scores at each visit: 0= Absent, 1= Mild, 2= Moderate, 3= Severe. A decrease in score compared to baseline represented a positive outcome. |
| Change From Baseline to Week 12 in the Severity of Dyspareunia | Baseline to Week 12 | Percentage of subjects with change from baseline to week 12 in the severity of dyspareunia was reported. Dyspareunia was only applicable in subjects who had experienced sexual activity with penetration since the previous study visit. Symptom scores at each visit: 0= Absent, 1= Mild, 2= Moderate, 3= Severe. A decrease in score compared to Baseline represented a positive outcome. |
| Change From Baseline to Week 3 in the Global Symptom Score 1 | Baseline to Week 3 | Global Symptom Score 1 was defined as the sum of all 5 individual symptom scores at a given visit, and was calculated only when all 5 symptom scores had a response available. the Global Symptom Score 1 ranged at Screening/Baseline between 2 (at least moderate vaginal dryness -per inclusion criteria) to 15 (all 5 studied symptoms severe in intensity). At Week 3 visit, the Global Symptom Score ranged between 0 (no symptoms) and 15 (all symptoms severe in intensity). A decrease in score compared to Baseline represented a positive outcome. |
| Change From Baseline to Week 3 in the Global Symptom Score 2 | Baseline to Week 3 | Change from Baseline to Week 3 in the Global Symptom Score 2 was reported. Global Symptom Score 2 was defined as the sum of all 4 individual symptoms excluding dyspareunia (vaginal dryness, pruritus or itching, burning, and dysuria) for each subject at each time point: Screening/Baseline, Week 3 and Week 12/ET., and was calculated only when all 4 symptom scores had a response available. The maximum score possible to be obtained at a visit with the Global Symptom Score 2 was 12 (all symptoms severe in intensity). A decrease in score compared to baseline represented a positive outcome. |
| Change From Baseline to Week 3 in the Severity of Pallor | Baseline to Week 3 | Percentage of subjects with change from Baseline to Week 3 in severity of pallor was reported. Sign scores at each visit: 0= Absent, 1= Mild, 2= Moderate, 3= Severe. A decrease in score compared to baseline represented a positive outcome. |
| Change From Baseline to Week 3 in the Severity of Friability | Baseline to Week 3 | Percentage of subjects with change from Baseline to Week 3 in severity of friability was reported. Sign scores at each visit: 0= Absent, 1= Mild, 2= Moderate, 3= Severe. A decrease in score compared to baseline represented a positive outcome. |
| Change From Baseline to Week 3 in the Severity of Thinning or Flattening of Folds | Baseline to Week 3 | Percentage of subjects with change from Baseline to Week 3 in severity of thinning or flattening of folds was reported. Sign scores at each visit: 0= Absent, 1= Mild, 2= Moderate, 3= Severe. A decrease in score compared to baseline represented a positive outcome. |
| Change From Baseline to Week 3 in the Severity of Presence of Petechiae | Baseline to Week 3 | Percentage of subjects with change from Baseline to Week 3 in the severity of presence of petechiae was reported. Sign scores at each visit: 0= Absent, 1= Mild, 2= Moderate, 3= Severe. A decrease in score compared to baseline represented a positive outcome. |
| Change From Baseline to Week 3 in the Severity of Dry Mucosa | Baseline to Week 3 | Percentage of subjects with change from Baseline to Week 3 in severity of dry mucosa was reported. Sign scores at each visit: 0= Absent, 1= Mild, 2= Moderate, 3= Severe. A decrease in score compared to baseline represented a positive outcome. |
| Change From Baseline to Week 3 in Vaginal pH | Baseline to Week 3 | Change from Baseline to Week 3 in vaginal pH was reported. A decrease in pH compared to Baseline represents a positive outcome. |
| Change From Baseline to Week 3 in the Proportion of Superficial Cells of the Vaginal Epithelium | Baseline to Week 3 | Change from baseline to week 3 in the proportion of superficial cells of the vaginal epithelium was reported. |
| Change From Baseline to Week 3 in the Proportion of Parabasal Cells of the Vaginal Epithelium | Baseline to Week 3 | Change from Baseline to Week 3 in the proportion of parabasal cells of the vaginal epithelium was reported. A decrease in proportion of parabasal cells compared to baseline represents a positive outcome. |
| Change From Baseline to Week 3 in the Severity of Dysuria | Baseline to Week 3 | Percentage of subjects with change from Baseline to Week 3 in severity of dysuria was reported. Symptom scores at each visit: 0= Absent, 1= Mild, 2= Moderate, 3= Severe. A decrease in score compared to baseline represented a positive outcome. |
| Change From Baseline to Week 12 in the Severity of Pruritus or Itching | Baseline to Week 12 | Percentage of subjects with cvhange from Baseline to Week 12 in the severity of pruritus or itching was reported. Symptom scores at each visit: 0= Absent, 1= Mild, 2= Moderate, 3= Severe. A decrease in score compared to Baseline represented a positive outcome. |
| Change From Baseline to Week 12 in the Severity of Burning | Baseline to Week 12 | Percentage of subjects with change from Baseline to Week 12 in the severity of burning was reported. Symptom scores at each visit: 0= Absent, 1= Mild, 2= Moderate, 3= Severe. A decrease in score compared to Baseline represented a positive outcome. |
| Change From Baseline to Week 12 in the Severity of Dysuria | Baseline to Week 12 | Percentage of subjects with change from Baseline to Week 12 in the severity of dysuria was reported. Symptom scores at each visit: 0= Absent, 1= Mild, 2= Moderate, 3= Severe. A decrease in score compared to baseline represented a positive putcome. |
Countries
Czechia, Hungary, Italy, Spain, Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Estriol 0.005% Subjects received 1 gram of Estriol 0.005% vaginal gel administered daily for Weeks 1-3. After 21 days of daily administration, treatment continued with twice-weekly administration up to Week 12 | 70 |
| Estriol 0.002% Subjects received 1 gram of Estriol 0.002% vaginal gel administered daily for Weeks 1-3. After 21 days of daily administration, treatment continued with twice-weekly administration up to Week 12 | 70 |
| Estriol 0.0008% Subjects received 1 gram of Estriol 0.0008% vaginal gel administered daily for Weeks 1-3. After 21 days of daily administration, treatment continued with twice-weekly administration up to Week 12 | 72 |
| Placebo Subjects received 1 gram of matching placebo vaginal gel administered daily for Weeks 1-3. After 21 days of daily administration, treatment continued with twice-weekly administration up to Week 12 | 71 |
| Total | 283 |
Baseline characteristics
| Characteristic | Estriol 0.005% | Total | Placebo | Estriol 0.0008% | Estriol 0.002% |
|---|---|---|---|---|---|
| Age, Continuous | 61.5 years STANDARD_DEVIATION 7.43 | 62.0 years STANDARD_DEVIATION 7.12 | 62.3 years STANDARD_DEVIATION 7.24 | 62.2 years STANDARD_DEVIATION 7.05 | 61.9 years STANDARD_DEVIATION 6.87 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 70 Participants | 282 Participants | 71 Participants | 71 Participants | 70 Participants |
| Sex: Female, Male Female | 70 Participants | 283 Participants | 71 Participants | 72 Participants | 70 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 70 | 0 / 69 | 0 / 72 | 0 / 71 |
| other Total, other adverse events | 14 / 70 | 11 / 69 | 15 / 72 | 20 / 71 |
| serious Total, serious adverse events | 0 / 70 | 0 / 69 | 0 / 72 | 3 / 71 |
Outcome results
Primary
Change From Baseline to Week 12 in the Proportion of Parabasal Cells of the Vaginal Epithelium.
Change from Baseline to Week 12 in the proportion of parabasal cells of the vaginal epithelium was reported. A decrease in proportion of parabasal cells compared to Baseline represents a positive outcome.
Time frame: Baseline to Week 12
Population: The ITT population defined as all randomized subjects. The number of subjects analyzed defined as number of subjects evaluable for this endpoint.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Estriol 0.005% | Change From Baseline to Week 12 in the Proportion of Parabasal Cells of the Vaginal Epithelium. | -0.54 ratio | Standard Error 0.036 |
| Estriol 0.002% | Change From Baseline to Week 12 in the Proportion of Parabasal Cells of the Vaginal Epithelium. | -0.51 ratio | Standard Error 0.037 |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Proportion of Parabasal Cells of the Vaginal Epithelium. | -0.47 ratio | Standard Error 0.036 |
| Placebo | Change From Baseline to Week 12 in the Proportion of Parabasal Cells of the Vaginal Epithelium. | -0.04 ratio | Standard Error 0.038 |
p-value: <0.00195% CI: [-0.603, -0.4]ANCOVA
p-value: <0.00195% CI: [-0.572, -0.365]ANCOVA
p-value: <0.00195% CI: [-0.531, -0.331]ANCOVA
Primary
Change From Baseline to Week 12 in the Proportion of Superficial Cells of the Vaginal Epithelium.
Change from Baseline to week 12 in the proportion of superficial cells of the vaginal epithelium was reported.
Time frame: Baseline to Week 12
Population: The ITT population defined as all randomized subjects. The number of subjects analyzed defined as number of subjects evaluable for this endpoint.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Estriol 0.005% | Change From Baseline to Week 12 in the Proportion of Superficial Cells of the Vaginal Epithelium. | 0.24 ratio | Standard Error 0.023 |
| Estriol 0.002% | Change From Baseline to Week 12 in the Proportion of Superficial Cells of the Vaginal Epithelium. | 0.17 ratio | Standard Error 0.024 |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Proportion of Superficial Cells of the Vaginal Epithelium. | 0.19 ratio | Standard Error 0.023 |
| Placebo | Change From Baseline to Week 12 in the Proportion of Superficial Cells of the Vaginal Epithelium. | 0.02 ratio | Standard Error 0.024 |
p-value: <0.00195% CI: [0.147, 0.278]ANCOVA
p-value: <0.00195% CI: [0.078, 0.213]ANCOVA
p-value: <0.00195% CI: [0.097, 0.226]ANCOVA
Primary
Change From Baseline to Week 12 in the Severity of Vaginal Dryness
Percentage of Subjects with change from baseline to week 12 in the severity of vaginal dryness was reported. Severity was defined as: 0= Absent, 1= Mild, 2= Moderate, 3= Severe. A decrease in score compared to Baseline represented a positive outcome.
Time frame: From baseline to week 12
Population: The ITT population defined as all randomized subjects. The number of subjects analyzed defined as number of subjects evaluable for this endpoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Vaginal Dryness | Change from Baseline: 0 | 4 Participants |
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Vaginal Dryness | Change from Baseline: -2 | 23 Participants |
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Vaginal Dryness | Change from Baseline: 1 | 2 Participants |
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Vaginal Dryness | Change from Baseline: -1 | 26 Participants |
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Vaginal Dryness | Change from Baseline: -3 | 15 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Vaginal Dryness | Change from Baseline: -1 | 16 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Vaginal Dryness | Change from Baseline: 0 | 6 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Vaginal Dryness | Change from Baseline: 1 | 0 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Vaginal Dryness | Change from Baseline: -2 | 33 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Vaginal Dryness | Change from Baseline: -3 | 13 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Vaginal Dryness | Change from Baseline: -1 | 20 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Vaginal Dryness | Change from Baseline: -3 | 13 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Vaginal Dryness | Change from Baseline: -2 | 26 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Vaginal Dryness | Change from Baseline: 0 | 11 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Vaginal Dryness | Change from Baseline: 1 | 0 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Vaginal Dryness | Change from Baseline: 0 | 13 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Vaginal Dryness | Change from Baseline: -2 | 26 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Vaginal Dryness | Change from Baseline: -3 | 9 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Vaginal Dryness | Change from Baseline: -1 | 19 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Vaginal Dryness | Change from Baseline: 1 | 1 Participants |
p-value: =0.30495% CI: [-1, 0]Wilcoxon rank-sum test
p-value: =0.10995% CI: [-1, 0]Wilcoxon rank-sum test
p-value: =0.11995% CI: [0, 0]Wilcoxon rank-sum test
Primary
Change From Baseline to Week 12 in Vaginal pH
Change from Baseline to Week 12 in Vaginal pH was reported. A decrease in pH compare to Baseline represents a positive outcome.
Time frame: Baseline to Week 12
Population: The ITT population defined as all randomized subjects. The number of subjects analyzed defined as number of subjects evaluable for this endpoint.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Estriol 0.005% | Change From Baseline to Week 12 in Vaginal pH | -1.03 pH | Standard Error 0.106 |
| Estriol 0.002% | Change From Baseline to Week 12 in Vaginal pH | -1.04 pH | Standard Error 0.108 |
| Estriol 0.0008% | Change From Baseline to Week 12 in Vaginal pH | -0.95 pH | Standard Error 0.107 |
| Placebo | Change From Baseline to Week 12 in Vaginal pH | -0.29 pH | Standard Error 0.108 |
p-value: <0.00195% CI: [-1.031, -0.444]ANCOVA
p-value: <0.00195% CI: [-1.051, -0.458]ANCOVA
p-value: <0.00195% CI: [-0.951, -0.369]ANCOVA
Secondary
Change From Baseline to Week 12 in the Global Symptom Score 1
Global Symptom Score 1 was defined as the sum of all 5 individual symptom scores at a given visit, and was calculated only when all 5 symptom scores had a response available. the Global Symptom Score 1 ranged at Screening/Baseline between 2 (at least moderate vaginal dryness -per inclusion criteria) to 15 (all 5 studied symptoms severe in intensity). At Week 12/ET visit, the Global Symptom Score ranged between 0 (no symptoms) and 15 (all symptoms severe in intensity). A decrease in score compared to Baseline represented a positive outcome.
Time frame: Baseline to Week 12
Population: The ITT population defined as all randomized subjects. The number of subjects analyzed defined as number of subjects evaluable for this endpoint.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Estriol 0.005% | Change From Baseline to Week 12 in the Global Symptom Score 1 | -4.30 units on a scale | Standard Error 0.425 |
| Estriol 0.002% | Change From Baseline to Week 12 in the Global Symptom Score 1 | -4.78 units on a scale | Standard Error 0.478 |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Global Symptom Score 1 | -4.51 units on a scale | Standard Error 0.412 |
| Placebo | Change From Baseline to Week 12 in the Global Symptom Score 1 | -4.54 units on a scale | Standard Error 0.467 |
p-value: =0.6595% CI: [-1, 1.487]ANCOVA
p-value: =0.36195% CI: [-1.568, 1.09]ANCOVA
p-value: =0.52295% CI: [-1.188, 1.257]ANCOVA
Secondary
Change From Baseline to Week 12 in the Global Symptom Score 2
Change from Baseline to Week 12 in the Global Symptom Score 2 was reported. Global Symptom Score 2 was defined as the sum of all 4 individual symptoms excluding dyspareunia (vaginal dryness, pruritus or itching, burning, and dysuria) for each subject at each time point: Screening/Baseline, Week 3 and Week 12/ET., and was calculated only when all 4 symptom scores had a response available. The maximum score possible to be obtained at a visit with the Global Symptom Score 2 was 12 (all symptoms severe in intensity). A decrease in score compared to baseline represented a positive outcome.
Time frame: Baseline to Week 12
Population: The ITT population defined as all randomized subjects. The number of subjects analyzed defined as number of subjects evaluable for this endpoint.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Estriol 0.005% | Change From Baseline to Week 12 in the Global Symptom Score 2 | -3.83 units on a scale | Standard Error 0.231 |
| Estriol 0.002% | Change From Baseline to Week 12 in the Global Symptom Score 2 | -3.78 units on a scale | Standard Error 0.234 |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Global Symptom Score 2 | -3.74 units on a scale | Standard Error 0.233 |
| Placebo | Change From Baseline to Week 12 in the Global Symptom Score 2 | -3.27 units on a scale | Standard Error 0.237 |
p-value: =0.04395% CI: [-1.204, 0.079]ANCOVA
p-value: =0.06195% CI: [-1.158, 0.137]ANCOVA
p-value: =0.07195% CI: [-1.111, 0.16]ANCOVA
Secondary
Change From Baseline to Week 12 in the Severity of Burning
Percentage of subjects with change from Baseline to Week 12 in the severity of burning was reported. Symptom scores at each visit: 0= Absent, 1= Mild, 2= Moderate, 3= Severe. A decrease in score compared to Baseline represented a positive outcome.
Time frame: Baseline to Week 12
Population: The ITT population defined as all randomized subjects. The number of subjects analyzed defined as number of subjects evaluable for this endpoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Burning | Change from Baseline: -3 | 5 Participants |
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Burning | Change from Baseline: 2 | 0 Participants |
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Burning | Change from Baseline: 1 | 0 Participants |
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Burning | Change from Baseline: -2 | 22 Participants |
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Burning | Change from Baseline: 3 | 0 Participants |
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Burning | Change from Baseline: -1 | 25 Participants |
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Burning | Change from Baseline: 0 | 18 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Burning | Change from Baseline: 2 | 1 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Burning | Change from Baseline: 0 | 24 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Burning | Change from Baseline: -1 | 17 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Burning | Change from Baseline: 1 | 1 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Burning | Change from Baseline: 3 | 0 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Burning | Change from Baseline: -2 | 21 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Burning | Change from Baseline: -3 | 4 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Burning | Change from Baseline: 0 | 26 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Burning | Change from Baseline: -3 | 7 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Burning | Change from Baseline: -2 | 18 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Burning | Change from Baseline: -1 | 18 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Burning | Change from Baseline: 1 | 1 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Burning | Change from Baseline: 2 | 0 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Burning | Change from Baseline: 3 | 0 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Burning | Change from Baseline: -1 | 23 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Burning | Change from Baseline: 3 | 0 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Burning | Change from Baseline: 2 | 1 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Burning | Change from Baseline: -2 | 19 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Burning | Change from Baseline: -3 | 4 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Burning | Change from Baseline: 1 | 2 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Burning | Change from Baseline: 0 | 20 Participants |
p-value: =0.12295% CI: [0, 0]Wilcoxon rank-sum test
p-value: =0.18895% CI: [0, 0]Wilcoxon rank-sum test
p-value: =0.22295% CI: [0, 0]Wilcoxon rank-sum test
Secondary
Change From Baseline to Week 12 in the Severity of Dry Mucosa
Percentage of subjects with change from Baseline to Week 12 in the severity of dry mucosa was reported. Sign scores at each visit: 0= Absent, 1= Mild, 2= Moderate, 3= Severe. A decrease in score compared to baseline represented a positive outcome.
Time frame: Baseline to Week 12
Population: The ITT population defined as all randomized subjects. The number of subjects analyzed defined as number of subjects evaluable for this endpoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Dry Mucosa | Change from Baseline: -3 | 8 Participants |
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Dry Mucosa | Change from Baseline: 2 | 0 Participants |
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Dry Mucosa | Change from Baseline: 1 | 1 Participants |
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Dry Mucosa | Change from Baseline: -2 | 39 Participants |
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Dry Mucosa | Change from Baseline: 3 | 0 Participants |
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Dry Mucosa | Change from Baseline: -1 | 17 Participants |
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Dry Mucosa | Change from Baseline: 0 | 5 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Dry Mucosa | Change from Baseline: 2 | 0 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Dry Mucosa | Change from Baseline: 0 | 6 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Dry Mucosa | Change from Baseline: -1 | 20 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Dry Mucosa | Change from Baseline: 1 | 0 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Dry Mucosa | Change from Baseline: 3 | 0 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Dry Mucosa | Change from Baseline: -2 | 29 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Dry Mucosa | Change from Baseline: -3 | 13 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Dry Mucosa | Change from Baseline: 0 | 6 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Dry Mucosa | Change from Baseline: -3 | 14 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Dry Mucosa | Change from Baseline: -2 | 26 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Dry Mucosa | Change from Baseline: -1 | 23 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Dry Mucosa | Change from Baseline: 1 | 1 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Dry Mucosa | Change from Baseline: 2 | 0 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Dry Mucosa | Change from Baseline: 3 | 0 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Dry Mucosa | Change from Baseline: -1 | 19 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Dry Mucosa | Change from Baseline: 3 | 0 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Dry Mucosa | Change from Baseline: 2 | 0 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Dry Mucosa | Change from Baseline: -2 | 19 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Dry Mucosa | Change from Baseline: -3 | 9 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Dry Mucosa | Change from Baseline: 1 | 3 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Dry Mucosa | Change from Baseline: 0 | 19 Participants |
p-value: =0.02295% CI: [-1, 0]Wilcoxon rank-sum test
p-value: =0.03295% CI: [-1, 0]Wilcoxon rank-sum test
p-value: =0.00195% CI: [-1, 0]Wilcoxon rank-sum test
Secondary
Change From Baseline to Week 12 in the Severity of Dyspareunia
Percentage of subjects with change from baseline to week 12 in the severity of dyspareunia was reported. Dyspareunia was only applicable in subjects who had experienced sexual activity with penetration since the previous study visit. Symptom scores at each visit: 0= Absent, 1= Mild, 2= Moderate, 3= Severe. A decrease in score compared to Baseline represented a positive outcome.
Time frame: Baseline to Week 12
Population: The ITT population defined as all randomized subjects. The number of subjects analyzed defined as number of subjects evaluable for this endpoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Dyspareunia | Change from Baseline: -3 | 7 Participants |
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Dyspareunia | Change from Baseline: 2 | 1 Participants |
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Dyspareunia | Change from Baseline: 1 | 0 Participants |
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Dyspareunia | Change from Baseline: -2 | 9 Participants |
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Dyspareunia | Change from Baseline: 3 | 0 Participants |
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Dyspareunia | Change from Baseline: -1 | 12 Participants |
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Dyspareunia | Change from Baseline: 0 | 10 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Dyspareunia | Change from Baseline: 2 | 0 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Dyspareunia | Change from Baseline: 0 | 5 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Dyspareunia | Change from Baseline: -1 | 13 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Dyspareunia | Change from Baseline: 1 | 1 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Dyspareunia | Change from Baseline: 3 | 0 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Dyspareunia | Change from Baseline: -2 | 7 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Dyspareunia | Change from Baseline: -3 | 5 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Dyspareunia | Change from Baseline: 0 | 5 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Dyspareunia | Change from Baseline: -3 | 4 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Dyspareunia | Change from Baseline: -2 | 16 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Dyspareunia | Change from Baseline: -1 | 12 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Dyspareunia | Change from Baseline: 1 | 3 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Dyspareunia | Change from Baseline: 2 | 1 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Dyspareunia | Change from Baseline: 3 | 0 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Dyspareunia | Change from Baseline: -1 | 8 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Dyspareunia | Change from Baseline: 3 | 0 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Dyspareunia | Change from Baseline: 2 | 1 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Dyspareunia | Change from Baseline: -2 | 11 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Dyspareunia | Change from Baseline: -3 | 3 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Dyspareunia | Change from Baseline: 1 | 0 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Dyspareunia | Change from Baseline: 0 | 9 Participants |
p-value: =0.4795% CI: [-1, 0]Wilcoxon rank-sum test
p-value: =0.44895% CI: [-1, 0]Wilcoxon rank-sum test
p-value: =0.45195% CI: [-1, 0]Wilcoxon rank-sum test
Secondary
Change From Baseline to Week 12 in the Severity of Dysuria
Percentage of subjects with change from Baseline to Week 12 in the severity of dysuria was reported. Symptom scores at each visit: 0= Absent, 1= Mild, 2= Moderate, 3= Severe. A decrease in score compared to baseline represented a positive putcome.
Time frame: Baseline to Week 12
Population: The ITT population defined as all randomized subjects. The number of subjects analyzed defined as number of subjects evaluable for this endpoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Dysuria | Change from Baseline: -3 | 0 Participants |
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Dysuria | Change from Baseline: 2 | 0 Participants |
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Dysuria | Change from Baseline: 1 | 1 Participants |
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Dysuria | Change from Baseline: -2 | 8 Participants |
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Dysuria | Change from Baseline: 3 | 0 Participants |
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Dysuria | Change from Baseline: -1 | 18 Participants |
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Dysuria | Change from Baseline: 0 | 43 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Dysuria | Change from Baseline: 2 | 0 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Dysuria | Change from Baseline: 0 | 39 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Dysuria | Change from Baseline: -1 | 19 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Dysuria | Change from Baseline: 1 | 1 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Dysuria | Change from Baseline: 3 | 0 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Dysuria | Change from Baseline: -2 | 8 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Dysuria | Change from Baseline: -3 | 1 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Dysuria | Change from Baseline: 0 | 40 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Dysuria | Change from Baseline: -3 | 1 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Dysuria | Change from Baseline: -2 | 5 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Dysuria | Change from Baseline: -1 | 17 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Dysuria | Change from Baseline: 1 | 7 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Dysuria | Change from Baseline: 2 | 0 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Dysuria | Change from Baseline: 3 | 0 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Dysuria | Change from Baseline: -1 | 15 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Dysuria | Change from Baseline: 3 | 2 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Dysuria | Change from Baseline: 2 | 2 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Dysuria | Change from Baseline: -2 | 5 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Dysuria | Change from Baseline: -3 | 1 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Dysuria | Change from Baseline: 1 | 0 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Dysuria | Change from Baseline: 0 | 44 Participants |
p-value: =0.39395% CI: [0, 0]Wilcoxon rank-sum test
p-value: =0.22195% CI: [0, 0]Wilcoxon rank-sum test
p-value: =0.43295% CI: [0, 0]Wilcoxon rank-sum test
Secondary
Change From Baseline to Week 12 in the Severity of Friability
Percentage of subjects with change from Baseline to Week 12 in the severity of friability was reported. Sign scores at each visit: 0= Absent, 1= Mild, 2= Moderate, 3= Severe. A decrease in score compared to baseline represented a positive outcome.
Time frame: Baseline to Week 12
Population: The ITT population defined as all randomized subjects. The number of subjects analyzed defined as number of subjects evaluable for this endpoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Friability | Change from Baseline: -3 | 2 Participants |
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Friability | Change from Baseline: 2 | 1 Participants |
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Friability | Change from Baseline: 1 | 1 Participants |
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Friability | Change from Baseline: -2 | 19 Participants |
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Friability | Change from Baseline: 3 | 0 Participants |
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Friability | Change from Baseline: -1 | 26 Participants |
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Friability | Change from Baseline: 0 | 21 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Friability | Change from Baseline: 2 | 1 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Friability | Change from Baseline: 0 | 22 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Friability | Change from Baseline: -1 | 22 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Friability | Change from Baseline: 1 | 0 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Friability | Change from Baseline: 3 | 0 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Friability | Change from Baseline: -2 | 21 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Friability | Change from Baseline: -3 | 2 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Friability | Change from Baseline: 0 | 16 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Friability | Change from Baseline: -3 | 2 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Friability | Change from Baseline: -2 | 18 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Friability | Change from Baseline: -1 | 31 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Friability | Change from Baseline: 1 | 3 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Friability | Change from Baseline: 2 | 0 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Friability | Change from Baseline: 3 | 0 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Friability | Change from Baseline: -1 | 20 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Friability | Change from Baseline: 3 | 0 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Friability | Change from Baseline: 2 | 0 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Friability | Change from Baseline: -2 | 19 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Friability | Change from Baseline: -3 | 3 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Friability | Change from Baseline: 1 | 3 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Friability | Change from Baseline: 0 | 24 Participants |
p-value: =0.43895% CI: [0, 0]Wilcoxon rank-sum test
p-value: =0.38895% CI: [0, 0]Wilcoxon rank-sum test
p-value: =0.25995% CI: [0, 0]Wilcoxon rank-sum test
Secondary
Change From Baseline to Week 12 in the Severity of Pallor.
Percentage of subjects with change from Baseline to Week 12 in the severity of pallor was reported. Sign scores at each visit: 0= Absent, 1= Mild, 2= Moderate, 3= Severe. A decrease in score compared to baseline represented a positive putcome.
Time frame: Baseline to Week 12
Population: The ITT population defined as all randomized subjects. The number of subjects analyzed defined as number of subjects evaluable for this endpoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Pallor. | Change from Baseline: -3 | 3 Participants |
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Pallor. | Change from Baseline: 2 | 0 Participants |
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Pallor. | Change from Baseline: 1 | 3 Participants |
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Pallor. | Change from Baseline: -2 | 17 Participants |
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Pallor. | Change from Baseline: 3 | 0 Participants |
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Pallor. | Change from Baseline: -1 | 31 Participants |
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Pallor. | Change from Baseline: 0 | 16 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Pallor. | Change from Baseline: 2 | 0 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Pallor. | Change from Baseline: 0 | 16 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Pallor. | Change from Baseline: -1 | 31 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Pallor. | Change from Baseline: 1 | 0 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Pallor. | Change from Baseline: 3 | 0 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Pallor. | Change from Baseline: -2 | 16 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Pallor. | Change from Baseline: -3 | 5 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Pallor. | Change from Baseline: 0 | 17 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Pallor. | Change from Baseline: -3 | 1 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Pallor. | Change from Baseline: -2 | 25 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Pallor. | Change from Baseline: -1 | 25 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Pallor. | Change from Baseline: 1 | 2 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Pallor. | Change from Baseline: 2 | 0 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Pallor. | Change from Baseline: 3 | 0 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Pallor. | Change from Baseline: -1 | 18 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Pallor. | Change from Baseline: 3 | 0 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Pallor. | Change from Baseline: 2 | 0 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Pallor. | Change from Baseline: -2 | 15 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Pallor. | Change from Baseline: -3 | 1 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Pallor. | Change from Baseline: 1 | 4 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Pallor. | Change from Baseline: 0 | 31 Participants |
p-value: =0.01295% CI: [-1, 0]Wilcoxon rank-sum test
p-value: =0.00795% CI: [-1, 0]Wilcoxon rank-sum test
p-value: <0.00195% CI: [-1, 0]Wilcoxon rank-sum test
Secondary
Change From Baseline to Week 12 in the Severity of Petechiae
Percentage of subjects with change from Baseline to Week 12 in the severity of presence of petechiae was reported. Sign scores at each visit: 0= Absent, 1= Mild, 2= Moderate, 3= Severe. A decrease in score compared to baseline represented a positive outcome.
Time frame: Baseline to Week 12
Population: The ITT population defined as all randomized subjects. The number of subjects analyzed defined as number of subjects evaluable for this endpoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Petechiae | Change from Baseline: 1 | 3 Participants |
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Petechiae | Change from Baseline: -1 | 26 Participants |
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Petechiae | Change from Baseline: 3 | 0 Participants |
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Petechiae | Change from Baseline: 0 | 29 Participants |
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Petechiae | Change from Baseline: 2 | 0 Participants |
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Petechiae | Change from Baseline: -3 | 2 Participants |
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Petechiae | Change from Baseline: -2 | 10 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Petechiae | Change from Baseline: 2 | 0 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Petechiae | Change from Baseline: 3 | 0 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Petechiae | Change from Baseline: -2 | 5 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Petechiae | Change from Baseline: -1 | 23 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Petechiae | Change from Baseline: -3 | 1 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Petechiae | Change from Baseline: 0 | 35 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Petechiae | Change from Baseline: 1 | 4 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Petechiae | Change from Baseline: 0 | 35 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Petechiae | Change from Baseline: -3 | 0 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Petechiae | Change from Baseline: -2 | 7 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Petechiae | Change from Baseline: 2 | 0 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Petechiae | Change from Baseline: 1 | 5 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Petechiae | Change from Baseline: -1 | 23 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Petechiae | Change from Baseline: 3 | 0 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Petechiae | Change from Baseline: 3 | 0 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Petechiae | Change from Baseline: -3 | 2 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Petechiae | Change from Baseline: -1 | 13 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Petechiae | Change from Baseline: 0 | 49 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Petechiae | Change from Baseline: 1 | 3 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Petechiae | Change from Baseline: 2 | 0 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Petechiae | Change from Baseline: -2 | 2 Participants |
p-value: =0.00295% CI: [-1, 0]Wilcoxon rank-sum test
p-value: =0.33195% CI: [0, 0]Wilcoxon rank-sum test
p-value: =0.04395% CI: [0, 0]Wilcoxon rank-sum test
Secondary
Change From Baseline to Week 12 in the Severity of Pruritus or Itching
Percentage of subjects with cvhange from Baseline to Week 12 in the severity of pruritus or itching was reported. Symptom scores at each visit: 0= Absent, 1= Mild, 2= Moderate, 3= Severe. A decrease in score compared to Baseline represented a positive outcome.
Time frame: Baseline to Week 12
Population: The ITT population defined as all randomized subjects. The number of subjects analyzed defined as number of subjects evaluable for this endpoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Pruritus or Itching | Change from Baseline: 1 | 0 Participants |
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Pruritus or Itching | Change from Baseline: 2 | 1 Participants |
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Pruritus or Itching | Change from Baseline: -2 | 16 Participants |
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Pruritus or Itching | Change from Baseline: -3 | 2 Participants |
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Pruritus or Itching | Change from Baseline: 3 | 0 Participants |
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Pruritus or Itching | Change from Baseline: 0 | 33 Participants |
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Pruritus or Itching | Change from Baseline: -1 | 18 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Pruritus or Itching | Change from Baseline: 3 | 1 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Pruritus or Itching | Change from Baseline: 2 | 2 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Pruritus or Itching | Change from Baseline: 0 | 22 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Pruritus or Itching | Change from Baseline: -3 | 5 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Pruritus or Itching | Change from Baseline: -1 | 20 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Pruritus or Itching | Change from Baseline: -2 | 14 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Pruritus or Itching | Change from Baseline: 1 | 4 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Pruritus or Itching | Change from Baseline: 2 | 1 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Pruritus or Itching | Change from Baseline: 3 | 0 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Pruritus or Itching | Change from Baseline: -3 | 4 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Pruritus or Itching | Change from Baseline: -2 | 15 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Pruritus or Itching | Change from Baseline: -1 | 20 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Pruritus or Itching | Change from Baseline: 0 | 28 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Pruritus or Itching | Change from Baseline: 1 | 2 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Pruritus or Itching | Change from Baseline: -1 | 20 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Pruritus or Itching | Change from Baseline: -2 | 13 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Pruritus or Itching | Change from Baseline: 2 | 2 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Pruritus or Itching | Change from Baseline: 1 | 5 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Pruritus or Itching | Change from Baseline: -3 | 4 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Pruritus or Itching | Change from Baseline: 3 | 0 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Pruritus or Itching | Change from Baseline: 0 | 25 Participants |
p-value: =0.32995% CI: [0, 0]Wilcoxon rank-sum test
p-value: =0.34895% CI: [0, 0]Wilcoxon rank-sum test
p-value: =0.26695% CI: [0, 0]Wilcoxon rank-sum test
Secondary
Change From Baseline to Week 12 in the Severity of Thinning or Flattening of Folds
Percentage of subjects with change from Baseline to Week 12 in the severity of thinning or flattening of folds was reported. Sign scores at each visit: 0= Absent, 1= Mild, 2= Moderate, 3= Severe. A decrease in score compared to baseline represented a positive outcome.
Time frame: Baseline to Week 12
Population: The ITT population defined as all randomized subjects. The number of subjects analyzed defined as number of subjects evaluable for this endpoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Thinning or Flattening of Folds | Change from Baseline: -3 | 4 Participants |
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Thinning or Flattening of Folds | Change from Baseline: 2 | 0 Participants |
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Thinning or Flattening of Folds | Change from Baseline: 1 | 2 Participants |
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Thinning or Flattening of Folds | Change from Baseline: -2 | 18 Participants |
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Thinning or Flattening of Folds | Change from Baseline: 3 | 0 Participants |
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Thinning or Flattening of Folds | Change from Baseline: -1 | 29 Participants |
| Estriol 0.005% | Change From Baseline to Week 12 in the Severity of Thinning or Flattening of Folds | Change from Baseline: 0 | 17 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Thinning or Flattening of Folds | Change from Baseline: 2 | 0 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Thinning or Flattening of Folds | Change from Baseline: 0 | 14 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Thinning or Flattening of Folds | Change from Baseline: -1 | 33 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Thinning or Flattening of Folds | Change from Baseline: 1 | 2 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Thinning or Flattening of Folds | Change from Baseline: 3 | 0 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Thinning or Flattening of Folds | Change from Baseline: -2 | 18 Participants |
| Estriol 0.002% | Change From Baseline to Week 12 in the Severity of Thinning or Flattening of Folds | Change from Baseline: -3 | 1 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Thinning or Flattening of Folds | Change from Baseline: 0 | 19 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Thinning or Flattening of Folds | Change from Baseline: -3 | 1 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Thinning or Flattening of Folds | Change from Baseline: -2 | 23 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Thinning or Flattening of Folds | Change from Baseline: -1 | 24 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Thinning or Flattening of Folds | Change from Baseline: 1 | 3 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Thinning or Flattening of Folds | Change from Baseline: 2 | 0 Participants |
| Estriol 0.0008% | Change From Baseline to Week 12 in the Severity of Thinning or Flattening of Folds | Change from Baseline: 3 | 0 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Thinning or Flattening of Folds | Change from Baseline: -1 | 31 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Thinning or Flattening of Folds | Change from Baseline: 3 | 0 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Thinning or Flattening of Folds | Change from Baseline: 2 | 0 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Thinning or Flattening of Folds | Change from Baseline: -2 | 6 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Thinning or Flattening of Folds | Change from Baseline: -3 | 1 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Thinning or Flattening of Folds | Change from Baseline: 1 | 5 Participants |
| Placebo | Change From Baseline to Week 12 in the Severity of Thinning or Flattening of Folds | Change from Baseline: 0 | 26 Participants |
p-value: =0.02295% CI: [-1, 0]Wilcoxon rank-sum test
p-value: =0.0295% CI: [-1, 0]Wilcoxon rank-sum test
p-value: =0.00395% CI: [-1, 0]Wilcoxon rank-sum test
Secondary
Change From Baseline to Week 3 in the Global Symptom Score 1
Global Symptom Score 1 was defined as the sum of all 5 individual symptom scores at a given visit, and was calculated only when all 5 symptom scores had a response available. the Global Symptom Score 1 ranged at Screening/Baseline between 2 (at least moderate vaginal dryness -per inclusion criteria) to 15 (all 5 studied symptoms severe in intensity). At Week 3 visit, the Global Symptom Score ranged between 0 (no symptoms) and 15 (all symptoms severe in intensity). A decrease in score compared to Baseline represented a positive outcome.
Time frame: Baseline to Week 3
Population: The ITT population defined as all randomized subjects. The number of subjects analyzed defined as number of subjects evaluable for this endpoint.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Estriol 0.005% | Change From Baseline to Week 3 in the Global Symptom Score 1 | -2.99 units on a scale | Standard Error 0.483 |
| Estriol 0.002% | Change From Baseline to Week 3 in the Global Symptom Score 1 | -2.86 units on a scale | Standard Error 0.52 |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Global Symptom Score 1 | -4.37 units on a scale | Standard Error 0.454 |
| Placebo | Change From Baseline to Week 3 in the Global Symptom Score 1 | -3.73 units on a scale | Standard Error 0.527 |
p-value: =0.8595% CI: [-0.669, 2.153]ANCOVA
p-value: =0.87795% CI: [-0.611, 2.361]ANCOVA
p-value: =0.17895% CI: [-2.009, 0.728]ANCOVA
Secondary
Change From Baseline to Week 3 in the Global Symptom Score 2
Change from Baseline to Week 3 in the Global Symptom Score 2 was reported. Global Symptom Score 2 was defined as the sum of all 4 individual symptoms excluding dyspareunia (vaginal dryness, pruritus or itching, burning, and dysuria) for each subject at each time point: Screening/Baseline, Week 3 and Week 12/ET., and was calculated only when all 4 symptom scores had a response available. The maximum score possible to be obtained at a visit with the Global Symptom Score 2 was 12 (all symptoms severe in intensity). A decrease in score compared to baseline represented a positive outcome.
Time frame: Baseline to Week 3
Population: The ITT population defined as all randomized subjects. The number of subjects analyzed defined as number of subjects evaluable for this endpoint.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Estriol 0.005% | Change From Baseline to Week 3 in the Global Symptom Score 2 | -2.76 units on a scale | Standard Error 0.251 |
| Estriol 0.002% | Change From Baseline to Week 3 in the Global Symptom Score 2 | -2.82 units on a scale | Standard Error 0.254 |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Global Symptom Score 2 | -3.20 units on a scale | Standard Error 0.253 |
| Placebo | Change From Baseline to Week 3 in the Global Symptom Score 2 | -2.60 units on a scale | Standard Error 0.255 |
p-value: =0.32395% CI: [-0.854, 0.531]ANCOVA
p-value: =0.27295% CI: [-0.917, 0.484]ANCOVA
p-value: =0.04395% CI: [-1.29, 0.084]ANCOVA
Secondary
Change From Baseline to Week 3 in the Proportion of Parabasal Cells of the Vaginal Epithelium
Change from Baseline to Week 3 in the proportion of parabasal cells of the vaginal epithelium was reported. A decrease in proportion of parabasal cells compared to baseline represents a positive outcome.
Time frame: Baseline to Week 3
Population: The ITT population defined as all randomized subjects. The number of subjects analyzed defined as number of subjects evaluable for this endpoint.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Estriol 0.005% | Change From Baseline to Week 3 in the Proportion of Parabasal Cells of the Vaginal Epithelium | -0.55 ratio | Standard Error 0.037 |
| Estriol 0.002% | Change From Baseline to Week 3 in the Proportion of Parabasal Cells of the Vaginal Epithelium | -0.57 ratio | Standard Error 0.037 |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Proportion of Parabasal Cells of the Vaginal Epithelium | -0.48 ratio | Standard Error 0.036 |
| Placebo | Change From Baseline to Week 3 in the Proportion of Parabasal Cells of the Vaginal Epithelium | -0.08 ratio | Standard Error 0.038 |
p-value: <0.00195% CI: [-0.575, -0.371]ANCOVA
p-value: <0.00195% CI: [-0.592, -0.383]ANCOVA
p-value: <0.00195% CI: [-0.5, -0.3]ANCOVA
Secondary
Change From Baseline to Week 3 in the Proportion of Superficial Cells of the Vaginal Epithelium
Change from baseline to week 3 in the proportion of superficial cells of the vaginal epithelium was reported.
Time frame: Baseline to Week 3
Population: The ITT population defined as all randomized subjects. The number of subjects analyzed defined as number of subjects evaluable for this endpoint.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Estriol 0.005% | Change From Baseline to Week 3 in the Proportion of Superficial Cells of the Vaginal Epithelium | 0.48 ratio | Standard Error 0.035 |
| Estriol 0.002% | Change From Baseline to Week 3 in the Proportion of Superficial Cells of the Vaginal Epithelium | 0.43 ratio | Standard Error 0.036 |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Proportion of Superficial Cells of the Vaginal Epithelium | 0.38 ratio | Standard Error 0.035 |
| Placebo | Change From Baseline to Week 3 in the Proportion of Superficial Cells of the Vaginal Epithelium | 0.04 ratio | Standard Error 0.037 |
p-value: <0.00195% CI: [0.337, 0.535]ANCOVA
p-value: <0.00195% CI: [0.291, 0.494]ANCOVA
p-value: <0.00195% CI: [0.245, 0.439]ANCOVA
Secondary
Change From Baseline to Week 3 in the Severity of Burning
Percentage of subjects with change from Baseline to Week 3 in severity of burning was reported. Symptom scores at each visit: 0= Absent, 1= Mild, 2= Moderate, 3= Severe. A decrease in score compared to baseline represented a positive outcome.
Time frame: Baseline to Week 3
Population: The ITT population defined as all randomized subjects. The number of subjects analyzed defined as number of subjects evaluable for this endpoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Burning | Change from Baseline: -3 | 3 Participants |
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Burning | Change from Baseline: 2 | 0 Participants |
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Burning | Change from Baseline: 1 | 0 Participants |
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Burning | Change from Baseline: -2 | 11 Participants |
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Burning | Change from Baseline: 3 | 0 Participants |
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Burning | Change from Baseline: -1 | 27 Participants |
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Burning | Change from Baseline: 0 | 27 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Burning | Change from Baseline: 2 | 1 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Burning | Change from Baseline: 0 | 28 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Burning | Change from Baseline: -1 | 18 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Burning | Change from Baseline: 1 | 1 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Burning | Change from Baseline: 3 | 0 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Burning | Change from Baseline: -2 | 17 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Burning | Change from Baseline: -3 | 2 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Burning | Change from Baseline: 0 | 29 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Burning | Change from Baseline: -3 | 4 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Burning | Change from Baseline: -2 | 14 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Burning | Change from Baseline: -1 | 20 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Burning | Change from Baseline: 1 | 1 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Burning | Change from Baseline: 2 | 0 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Burning | Change from Baseline: 3 | 0 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Burning | Change from Baseline: -1 | 21 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Burning | Change from Baseline: 3 | 0 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Burning | Change from Baseline: 2 | 1 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Burning | Change from Baseline: -2 | 16 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Burning | Change from Baseline: -3 | 0 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Burning | Change from Baseline: 1 | 2 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Burning | Change from Baseline: 0 | 28 Participants |
p-value: =0.3695% CI: [0, 0]Wilcoxon rank-sum test
p-value: =0.1295% CI: [0, 0]Wilcoxon rank-sum test
p-value: =0.26695% CI: [0, 0]Wilcoxon rank-sum test
Secondary
Change From Baseline to Week 3 in the Severity of Dry Mucosa
Percentage of subjects with change from Baseline to Week 3 in severity of dry mucosa was reported. Sign scores at each visit: 0= Absent, 1= Mild, 2= Moderate, 3= Severe. A decrease in score compared to baseline represented a positive outcome.
Time frame: Baseline to Week 3
Population: The ITT population defined as all randomized subjects. The number of subjects analyzed defined as number of subjects evaluable for this endpoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Dry Mucosa | Change from Baseline: -3 | 4 Participants |
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Dry Mucosa | Change from Baseline: 2 | 0 Participants |
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Dry Mucosa | Change from Baseline: 1 | 1 Participants |
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Dry Mucosa | Change from Baseline: -2 | 29 Participants |
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Dry Mucosa | Change from Baseline: 3 | 0 Participants |
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Dry Mucosa | Change from Baseline: -1 | 22 Participants |
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Dry Mucosa | Change from Baseline: 0 | 12 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Dry Mucosa | Change from Baseline: 2 | 0 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Dry Mucosa | Change from Baseline: 0 | 9 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Dry Mucosa | Change from Baseline: -1 | 30 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Dry Mucosa | Change from Baseline: 1 | 0 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Dry Mucosa | Change from Baseline: 3 | 0 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Dry Mucosa | Change from Baseline: -2 | 20 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Dry Mucosa | Change from Baseline: -3 | 8 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Dry Mucosa | Change from Baseline: 0 | 15 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Dry Mucosa | Change from Baseline: -3 | 6 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Dry Mucosa | Change from Baseline: -2 | 26 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Dry Mucosa | Change from Baseline: -1 | 21 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Dry Mucosa | Change from Baseline: 1 | 0 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Dry Mucosa | Change from Baseline: 2 | 0 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Dry Mucosa | Change from Baseline: 3 | 0 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Dry Mucosa | Change from Baseline: -1 | 20 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Dry Mucosa | Change from Baseline: 3 | 0 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Dry Mucosa | Change from Baseline: 2 | 0 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Dry Mucosa | Change from Baseline: -2 | 17 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Dry Mucosa | Change from Baseline: -3 | 3 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Dry Mucosa | Change from Baseline: 1 | 2 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Dry Mucosa | Change from Baseline: 0 | 26 Participants |
p-value: =0.00895% CI: [-1, 0]Wilcoxon rank-sum test
p-value: =0.0195% CI: [-1, 0]Wilcoxon rank-sum test
p-value: =0.00195% CI: [-1, 0]Wilcoxon rank-sum test
Secondary
Change From Baseline to Week 3 in the Severity of Dyspareunia
Percentage of subjects with change from Baseline to Week 3 in severity of dyspareunia was reported. Dyspareunia was only applicable in subjects who had experienced sexual activity with penetration since the previous study visit. Symptom scores at each visit: 0= Absent, 1= Mild, 2= Moderate, 3= Severe. A decrease in score compared to baseline represented a positive outcome.
Time frame: From baseline to week 3
Population: The ITT population defined as all randomized subjects. The number of subjects analyzed defined as number of subjects evaluable for this endpoint
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Dyspareunia | Change from Baseline: -3 | 1 Participants |
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Dyspareunia | Change from Baseline: 2 | 1 Participants |
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Dyspareunia | Change from Baseline: 1 | 0 Participants |
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Dyspareunia | Change from Baseline: -2 | 7 Participants |
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Dyspareunia | Change from Baseline: 3 | 0 Participants |
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Dyspareunia | Change from Baseline: -1 | 11 Participants |
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Dyspareunia | Change from Baseline: 0 | 13 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Dyspareunia | Change from Baseline: 2 | 1 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Dyspareunia | Change from Baseline: 0 | 6 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Dyspareunia | Change from Baseline: -1 | 11 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Dyspareunia | Change from Baseline: 1 | 4 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Dyspareunia | Change from Baseline: 3 | 0 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Dyspareunia | Change from Baseline: -2 | 4 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Dyspareunia | Change from Baseline: -3 | 3 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Dyspareunia | Change from Baseline: 0 | 8 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Dyspareunia | Change from Baseline: -3 | 4 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Dyspareunia | Change from Baseline: -2 | 10 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Dyspareunia | Change from Baseline: -1 | 14 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Dyspareunia | Change from Baseline: 1 | 0 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Dyspareunia | Change from Baseline: 2 | 1 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Dyspareunia | Change from Baseline: 3 | 0 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Dyspareunia | Change from Baseline: -1 | 10 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Dyspareunia | Change from Baseline: 3 | 0 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Dyspareunia | Change from Baseline: 2 | 0 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Dyspareunia | Change from Baseline: -2 | 7 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Dyspareunia | Change from Baseline: -3 | 2 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Dyspareunia | Change from Baseline: 1 | 1 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Dyspareunia | Change from Baseline: 0 | 7 Participants |
p-value: =0.10695% CI: [0, 1]Wilcoxon rank-sum test
p-value: =0.22995% CI: [0, 1]Wilcoxon rank-sum test
p-value: =0.34595% CI: [-1, 0]Wilcoxon rank-sum test
Secondary
Change From Baseline to Week 3 in the Severity of Dysuria
Percentage of subjects with change from Baseline to Week 3 in severity of dysuria was reported. Symptom scores at each visit: 0= Absent, 1= Mild, 2= Moderate, 3= Severe. A decrease in score compared to baseline represented a positive outcome.
Time frame: Baseline to Week 3
Population: The ITT population defined as all randomized subjects. The number of subjects analyzed defined as number of subjects evaluable for this endpoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Dysuria | Change from Baseline: -2 | 5 Participants |
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Dysuria | Change from Baseline: 0 | 46 Participants |
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Dysuria | Change from Baseline: -1 | 14 Participants |
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Dysuria | Change from Baseline: 1 | 3 Participants |
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Dysuria | Change from Baseline: 2 | 0 Participants |
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Dysuria | Change from Baseline: 3 | 0 Participants |
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Dysuria | Change from Baseline: -3 | 0 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Dysuria | Change from Baseline: -2 | 8 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Dysuria | Change from Baseline: 0 | 39 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Dysuria | Change from Baseline: 1 | 3 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Dysuria | Change from Baseline: -1 | 16 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Dysuria | Change from Baseline: 2 | 0 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Dysuria | Change from Baseline: 3 | 1 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Dysuria | Change from Baseline: -3 | 0 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Dysuria | Change from Baseline: -2 | 3 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Dysuria | Change from Baseline: 3 | 0 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Dysuria | Change from Baseline: 0 | 48 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Dysuria | Change from Baseline: -3 | 1 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Dysuria | Change from Baseline: -1 | 14 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Dysuria | Change from Baseline: 2 | 0 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Dysuria | Change from Baseline: 1 | 2 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Dysuria | Change from Baseline: 3 | 2 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Dysuria | Change from Baseline: -2 | 6 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Dysuria | Change from Baseline: -1 | 9 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Dysuria | Change from Baseline: 0 | 48 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Dysuria | Change from Baseline: 1 | 3 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Dysuria | Change from Baseline: -3 | 0 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Dysuria | Change from Baseline: 2 | 0 Participants |
p-value: =0.4795% CI: [0, 0]Wilcoxon rank-sum test
p-value: =0.13795% CI: [0, 0]Wilcoxon rank-sum test
p-value: =0.13395% CI: [0, 0]Wilcoxon rank-sum test
Secondary
Change From Baseline to Week 3 in the Severity of Friability
Percentage of subjects with change from Baseline to Week 3 in severity of friability was reported. Sign scores at each visit: 0= Absent, 1= Mild, 2= Moderate, 3= Severe. A decrease in score compared to baseline represented a positive outcome.
Time frame: Baseline to Week 3
Population: The ITT population defined as all randomized subjects. The number of subjects analyzed defined as number of subjects evaluable for this endpoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Friability | Change from Baseline: -3 | 2 Participants |
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Friability | Change from Baseline: -1 | 29 Participants |
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Friability | Change from Baseline: 2 | 0 Participants |
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Friability | Change from Baseline: 0 | 22 Participants |
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Friability | Change from Baseline: 3 | 0 Participants |
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Friability | Change from Baseline: 1 | 1 Participants |
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Friability | Change from Baseline: -2 | 14 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Friability | Change from Baseline: 1 | 3 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Friability | Change from Baseline: -3 | 2 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Friability | Change from Baseline: 0 | 25 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Friability | Change from Baseline: 3 | 0 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Friability | Change from Baseline: -2 | 11 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Friability | Change from Baseline: -1 | 25 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Friability | Change from Baseline: 2 | 1 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Friability | Change from Baseline: 0 | 27 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Friability | Change from Baseline: 1 | 2 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Friability | Change from Baseline: 2 | 0 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Friability | Change from Baseline: 3 | 0 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Friability | Change from Baseline: -3 | 1 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Friability | Change from Baseline: -2 | 13 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Friability | Change from Baseline: -1 | 25 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Friability | Change from Baseline: -3 | 0 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Friability | Change from Baseline: 3 | 0 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Friability | Change from Baseline: 0 | 32 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Friability | Change from Baseline: -1 | 24 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Friability | Change from Baseline: 2 | 0 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Friability | Change from Baseline: 1 | 3 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Friability | Change from Baseline: -2 | 9 Participants |
p-value: =0.0495% CI: [-1, 0]Wilcoxon rank-sum test
p-value: =0.25995% CI: [0, 0]Wilcoxon rank-sum test
p-value: =0.10495% CI: [0, 0]Wilcoxon rank-sum test
Secondary
Change From Baseline to Week 3 in the Severity of Pallor
Percentage of subjects with change from Baseline to Week 3 in severity of pallor was reported. Sign scores at each visit: 0= Absent, 1= Mild, 2= Moderate, 3= Severe. A decrease in score compared to baseline represented a positive outcome.
Time frame: Baseline to Week 3
Population: The ITT population defined as all randomized subjects. The number of subjects analyzed defined as number of subjects evaluable for this endpoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Pallor | Change from Baseline: -3 | 3 Participants |
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Pallor | Change from Baseline: 2 | 0 Participants |
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Pallor | Change from Baseline: 1 | 1 Participants |
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Pallor | Change from Baseline: -2 | 14 Participants |
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Pallor | Change from Baseline: 3 | 0 Participants |
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Pallor | Change from Baseline: -1 | 19 Participants |
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Pallor | Change from Baseline: 0 | 31 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Pallor | Change from Baseline: 2 | 0 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Pallor | Change from Baseline: 0 | 30 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Pallor | Change from Baseline: -1 | 20 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Pallor | Change from Baseline: 1 | 1 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Pallor | Change from Baseline: 3 | 0 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Pallor | Change from Baseline: -2 | 14 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Pallor | Change from Baseline: -3 | 2 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Pallor | Change from Baseline: 0 | 29 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Pallor | Change from Baseline: -3 | 1 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Pallor | Change from Baseline: -2 | 14 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Pallor | Change from Baseline: -1 | 24 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Pallor | Change from Baseline: 1 | 0 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Pallor | Change from Baseline: 2 | 0 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Pallor | Change from Baseline: 3 | 0 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Pallor | Change from Baseline: -1 | 19 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Pallor | Change from Baseline: 3 | 0 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Pallor | Change from Baseline: 2 | 0 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Pallor | Change from Baseline: -2 | 6 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Pallor | Change from Baseline: -3 | 0 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Pallor | Change from Baseline: 1 | 5 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Pallor | Change from Baseline: 0 | 38 Participants |
p-value: =0.00995% CI: [-1, 0]Wilcoxon rank-sum test
p-value: =0.02595% CI: [-1, 0]Wilcoxon rank-sum test
p-value: <0.00195% CI: [-1, 0]Wilcoxon rank-sum test
Secondary
Change From Baseline to Week 3 in the Severity of Presence of Petechiae
Percentage of subjects with change from Baseline to Week 3 in the severity of presence of petechiae was reported. Sign scores at each visit: 0= Absent, 1= Mild, 2= Moderate, 3= Severe. A decrease in score compared to baseline represented a positive outcome.
Time frame: Baseline to Week 3
Population: The ITT population defined as all randomized subjects. The number of subjects analyzed defined as number of subjects evaluable for this endpoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Presence of Petechiae | Change from Baseline: -3 | 2 Participants |
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Presence of Petechiae | Change from Baseline: 2 | 1 Participants |
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Presence of Petechiae | Change from Baseline: 1 | 3 Participants |
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Presence of Petechiae | Change from Baseline: -2 | 8 Participants |
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Presence of Petechiae | Change from Baseline: 3 | 0 Participants |
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Presence of Petechiae | Change from Baseline: -1 | 23 Participants |
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Presence of Petechiae | Change from Baseline: 0 | 31 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Presence of Petechiae | Change from Baseline: 2 | 0 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Presence of Petechiae | Change from Baseline: 0 | 41 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Presence of Petechiae | Change from Baseline: -1 | 18 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Presence of Petechiae | Change from Baseline: 1 | 2 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Presence of Petechiae | Change from Baseline: 3 | 0 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Presence of Petechiae | Change from Baseline: -2 | 6 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Presence of Petechiae | Change from Baseline: -3 | 0 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Presence of Petechiae | Change from Baseline: 0 | 38 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Presence of Petechiae | Change from Baseline: -3 | 0 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Presence of Petechiae | Change from Baseline: -2 | 6 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Presence of Petechiae | Change from Baseline: -1 | 22 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Presence of Petechiae | Change from Baseline: 1 | 1 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Presence of Petechiae | Change from Baseline: 2 | 1 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Presence of Petechiae | Change from Baseline: 3 | 0 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Presence of Petechiae | Change from Baseline: -1 | 7 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Presence of Petechiae | Change from Baseline: 3 | 0 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Presence of Petechiae | Change from Baseline: 2 | 1 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Presence of Petechiae | Change from Baseline: -2 | 3 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Presence of Petechiae | Change from Baseline: -3 | 0 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Presence of Petechiae | Change from Baseline: 1 | 3 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Presence of Petechiae | Change from Baseline: 0 | 54 Participants |
p-value: <0.00195% CI: [-1, 0]Wilcoxon rank-sum test
p-value: =0.05495% CI: [0, 0]Wilcoxon rank-sum test
p-value: <0.00195% CI: [0, 0]Wilcoxon rank-sum test
Secondary
Change From Baseline to Week 3 in the Severity of Pruritus or Itching
Percentage of subjects with change from Baseline to Week 3 in the severity of pruritus or itching was reported. Symptom scores at each visit: 0= Absent, 1= Mild, 2= Moderate, 3= Severe. A decrease in score compared to baseline represented a positive outcome.
Time frame: Baseline to Week 3
Population: The ITT population defined as all randomized subjects. The number of subjects analyzed defined as number of subjects evaluable for this endpoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Pruritus or Itching | Change from Baseline: -2 | 10 Participants |
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Pruritus or Itching | Change from Baseline: 1 | 5 Participants |
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Pruritus or Itching | Change from Baseline: 0 | 35 Participants |
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Pruritus or Itching | Change from Baseline: -3 | 1 Participants |
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Pruritus or Itching | Change from Baseline: 3 | 0 Participants |
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Pruritus or Itching | Change from Baseline: 2 | 2 Participants |
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Pruritus or Itching | Change from Baseline: -1 | 15 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Pruritus or Itching | Change from Baseline: -3 | 4 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Pruritus or Itching | Change from Baseline: -2 | 10 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Pruritus or Itching | Change from Baseline: -1 | 19 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Pruritus or Itching | Change from Baseline: 0 | 27 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Pruritus or Itching | Change from Baseline: 1 | 2 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Pruritus or Itching | Change from Baseline: 2 | 4 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Pruritus or Itching | Change from Baseline: 3 | 1 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Pruritus or Itching | Change from Baseline: 1 | 2 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Pruritus or Itching | Change from Baseline: -2 | 7 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Pruritus or Itching | Change from Baseline: -3 | 2 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Pruritus or Itching | Change from Baseline: 2 | 0 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Pruritus or Itching | Change from Baseline: 3 | 0 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Pruritus or Itching | Change from Baseline: 0 | 27 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Pruritus or Itching | Change from Baseline: -1 | 30 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Pruritus or Itching | Change from Baseline: 0 | 30 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Pruritus or Itching | Change from Baseline: 3 | 0 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Pruritus or Itching | Change from Baseline: 1 | 0 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Pruritus or Itching | Change from Baseline: -2 | 10 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Pruritus or Itching | Change from Baseline: -3 | 1 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Pruritus or Itching | Change from Baseline: 2 | 3 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Pruritus or Itching | Change from Baseline: -1 | 24 Participants |
p-value: =0.02695% CI: [0, 0]Wilcoxon rank-sum test
p-value: =0.42495% CI: [0, 0]Wilcoxon rank-sum test
p-value: =0.41495% CI: [0, 0]Wilcoxon rank-sum test
Secondary
Change From Baseline to Week 3 in the Severity of Thinning or Flattening of Folds
Percentage of subjects with change from Baseline to Week 3 in severity of thinning or flattening of folds was reported. Sign scores at each visit: 0= Absent, 1= Mild, 2= Moderate, 3= Severe. A decrease in score compared to baseline represented a positive outcome.
Time frame: Baseline to Week 3
Population: The ITT population defined as all randomized subjects. The number of subjects analyzed defined as number of subjects evaluable for this endpoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Thinning or Flattening of Folds | Change from Baseline: -3 | 1 Participants |
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Thinning or Flattening of Folds | Change from Baseline: 2 | 0 Participants |
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Thinning or Flattening of Folds | Change from Baseline: 1 | 3 Participants |
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Thinning or Flattening of Folds | Change from Baseline: -2 | 12 Participants |
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Thinning or Flattening of Folds | Change from Baseline: 3 | 0 Participants |
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Thinning or Flattening of Folds | Change from Baseline: -1 | 32 Participants |
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Thinning or Flattening of Folds | Change from Baseline: 0 | 20 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Thinning or Flattening of Folds | Change from Baseline: 2 | 0 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Thinning or Flattening of Folds | Change from Baseline: 0 | 21 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Thinning or Flattening of Folds | Change from Baseline: -1 | 35 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Thinning or Flattening of Folds | Change from Baseline: 1 | 1 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Thinning or Flattening of Folds | Change from Baseline: 3 | 0 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Thinning or Flattening of Folds | Change from Baseline: -2 | 9 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Thinning or Flattening of Folds | Change from Baseline: -3 | 1 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Thinning or Flattening of Folds | Change from Baseline: 0 | 26 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Thinning or Flattening of Folds | Change from Baseline: -3 | 0 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Thinning or Flattening of Folds | Change from Baseline: -2 | 10 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Thinning or Flattening of Folds | Change from Baseline: -1 | 31 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Thinning or Flattening of Folds | Change from Baseline: 1 | 1 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Thinning or Flattening of Folds | Change from Baseline: 2 | 0 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Thinning or Flattening of Folds | Change from Baseline: 3 | 0 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Thinning or Flattening of Folds | Change from Baseline: -1 | 16 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Thinning or Flattening of Folds | Change from Baseline: 3 | 0 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Thinning or Flattening of Folds | Change from Baseline: 2 | 0 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Thinning or Flattening of Folds | Change from Baseline: -2 | 5 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Thinning or Flattening of Folds | Change from Baseline: -3 | 0 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Thinning or Flattening of Folds | Change from Baseline: 1 | 4 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Thinning or Flattening of Folds | Change from Baseline: 0 | 43 Participants |
p-value: <0.00195% CI: [-1, 0]Wilcoxon rank-sum test
p-value: <0.00195% CI: [-1, 0]Wilcoxon rank-sum test
p-value: <0.00195% CI: [-1, 0]Wilcoxon rank-sum test
Secondary
Change From Baseline to Week 3 in the Severity of Vaginal Dryness
Percentage of subjects with change from Baseline to Week 3 in the severity of vaginal dryness was reported. Severity was defined as: 0= Absent, 1= Mild, 2= Moderate, 3= Severe. A decrease in score compared to baseline represented a positive outcome.
Time frame: Baseline to Week 3
Population: The ITT population defined as all randomized subjects. The number of subjects analyzed defined as number of subjects evaluable for this endpoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Vaginal Dryness | Change from Baseline: 1 | 3 Participants |
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Vaginal Dryness | Change from Baseline: -3 | 6 Participants |
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Vaginal Dryness | Change from Baseline: -1 | 28 Participants |
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Vaginal Dryness | Change from Baseline: 0 | 8 Participants |
| Estriol 0.005% | Change From Baseline to Week 3 in the Severity of Vaginal Dryness | Change from Baseline: -2 | 23 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Vaginal Dryness | Change from Baseline: -1 | 33 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Vaginal Dryness | Change from Baseline: -3 | 8 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Vaginal Dryness | Change from Baseline: -2 | 13 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Vaginal Dryness | Change from Baseline: 0 | 12 Participants |
| Estriol 0.002% | Change From Baseline to Week 3 in the Severity of Vaginal Dryness | Change from Baseline: 1 | 0 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Vaginal Dryness | Change from Baseline: -1 | 26 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Vaginal Dryness | Change from Baseline: -3 | 8 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Vaginal Dryness | Change from Baseline: 1 | 1 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Vaginal Dryness | Change from Baseline: 0 | 11 Participants |
| Estriol 0.0008% | Change From Baseline to Week 3 in the Severity of Vaginal Dryness | Change from Baseline: -2 | 22 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Vaginal Dryness | Change from Baseline: -1 | 26 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Vaginal Dryness | Change from Baseline: -3 | 3 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Vaginal Dryness | Change from Baseline: 0 | 11 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Vaginal Dryness | Change from Baseline: 1 | 2 Participants |
| Placebo | Change From Baseline to Week 3 in the Severity of Vaginal Dryness | Change from Baseline: -2 | 26 Participants |
p-value: =0.17695% CI: [0, 0]Wilcoxon rank-sum test
p-value: =0.35895% CI: [0, 0]Wilcoxon rank-sum test
p-value: =0.2195% CI: [0, 0]Wilcoxon rank-sum test
Secondary
Change From Baseline to Week 3 in Vaginal pH
Change from Baseline to Week 3 in vaginal pH was reported. A decrease in pH compared to Baseline represents a positive outcome.
Time frame: Baseline to Week 3
Population: The ITT population defined as all randomized subjects. The number of subjects analyzed defined as number of subjects evaluable for this endpoint.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Estriol 0.005% | Change From Baseline to Week 3 in Vaginal pH | -1.03 pH | Standard Error 0.095 |
| Estriol 0.002% | Change From Baseline to Week 3 in Vaginal pH | -0.97 pH | Standard Error 0.096 |
| Estriol 0.0008% | Change From Baseline to Week 3 in Vaginal pH | -0.88 pH | Standard Error 0.095 |
| Placebo | Change From Baseline to Week 3 in Vaginal pH | -0.22 pH | Standard Error 0.096 |
p-value: <0.00195% CI: [-1.071, -0.548]ANCOVA
p-value: <0.00195% CI: [-1.013, -0.484]ANCOVA
p-value: <0.00195% CI: [-0.916, -0.397]ANCOVA