Vaginal Atrophy
Conditions
Keywords
Vulvar/vaginal atrophy, Atrophic Vaginitis, Dehydroepiandrosterone, DHEA, Prasterone, Vaginorm, Menopause, Intrarosa
Brief summary
The purpose of this study is to determine the dose-response of vaginal mucosa parameters to the local action of DHEA (Dehydroepiandrosterone) in postmenopausal women suffering from vaginal atrophy.
Interventions
DRUGPlacebo
Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.
DRUGDHEA (0.25%)
Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
DRUGDHEA (0.5%)
Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
DRUGDHEA (1.0%)
Vaginal suppository containing 1.0% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
Sponsors
EndoCeutics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Postmenopausal women (non hysterectomized or hysterectomized) * Women between 40 and 75 years of age * Willing to participate in the study and sign an informed consent * Women having a low maturation index (no greater part of guidance than 5% of superficial cells on vaginal smear) * Women having a vaginal pH above 5 * Women who have self-identified at least one moderate to severe symptoms of vulvovaginal atrophy
Exclusion criteria
* Undiagnosed abnormal genital bleeding * Hypertension equal to or above 160/95 mm Hg or not controlled by standard therapy * The administration of any investigational drug within 30 days of screening visit * Endometrial hyperplasia at biopsy performed at screening or endometrial cancer * Use of estrogens/progestins products (vaginal, oral, pellet, transdermal, etc) in the 4 weeks to 6 months (depending on the product used) prior study entry
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Co-primary Endpoint: Change From Baseline to Week 12 of Self-assessment of the Most Bothersome Symptom Dyspareunia | Baseline and Week 12 | The severity of dyspareunia was evaluated by a questionnaire. The severity of dyspareunia recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented. |
| Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Parabasal Cells) | Baseline and Week 12 | The percentage of parabasal cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented. |
| Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Superficial Cells) | Baseline and Week 12 | The percentage of superficial cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented. |
| Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal pH. | Baseline and Week 12 | A pH strip was applied directly to the lateral wall of the vagina using forceps. The change in color of the pH indicator strip was compared to the color chart for pH evaluation. The corresponding pH value (with one decimal) was recorded. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Week 12 of Vaginal Secretions | Baseline and Week 12 | To evaluate the aspect of the vaginal mucosa and the local tolerance to DHEA suppository, the vaginal secretions (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy were analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented. |
| Change From Baseline to Week 12 of Vaginal Epithelial Integrity | Baseline and Week 12 | To evaluate the aspect of the vaginal mucosa and the local tolerance to DHEA suppository, the vaginal epithelial integrity (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented. |
| Change From Baseline to Week 12 of Vaginal Epithelial Surface Thickness | Baseline and Week 12 | To evaluate the aspect of the vaginal mucosa and the local tolerance to DHEA suppository, the vaginal epithelial surface thickness(one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented. |
| Change From Baseline to Week 12 of Vaginal Color | Baseline and Week 12 | To evaluate the aspect of the vaginal mucosa and the local tolerance to DHEA suppository, the vaginal color (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented. |
Countries
Canada, United States
Participant flow
Recruitment details
A total of 403 subjects were screened at 8 medical/research sites located in the US (2 centers) and Canada (6 centers) and 218 subjects were randomized. The first subject first visit was on 28-JUN-2007 and the last subject last visit was on 23-MAY-2008.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks. | 54 |
| 0.25% DHEA DHEA (0.25%): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks. | 53 |
| 0.50% DHEA DHEA (0.50%): Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks. | 56 |
| 1.00% DHEA DHEA (1.00%): Vaginal suppository containing 1.00% (13 mg) DHEA; daily dosing with one suppository for 12 weeks. | 54 |
| Total | 217 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 4 | 2 | 1 |
| Overall Study | Left the city/Lost medication | 1 | 0 | 1 | 1 |
| Overall Study | Lost to Follow-up | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 2 | 0 | 1 |
Baseline characteristics
| Characteristic | Placebo | 0.25% DHEA | 0.50% DHEA | 1.00% DHEA | Total |
|---|---|---|---|---|---|
| Age, Continuous | 59.00 years STANDARD_DEVIATION 5.4 | 57.68 years STANDARD_DEVIATION 6.31 | 58.45 years STANDARD_DEVIATION 5.55 | 59.44 years STANDARD_DEVIATION 4.63 | 58.65 years STANDARD_DEVIATION 5.5 |
| Race/Ethnicity, Customized Asian | 3 Participants | 1 Participants | 1 Participants | 1 Participants | 6 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized White Caucasian | 50 Participants | 51 Participants | 54 Participants | 53 Participants | 208 Participants |
| Sex/Gender, Customized Female | 54 Participants | 53 Participants | 56 Participants | 54 Participants | 217 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 | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 34 / 54 | 32 / 53 | 46 / 56 | 39 / 54 |
| serious Total, serious adverse events | 0 / 54 | 1 / 53 | 1 / 56 | 0 / 54 |
Outcome results
Primary
Co-primary Endpoint: Change From Baseline to Week 12 of Self-assessment of the Most Bothersome Symptom Dyspareunia
The severity of dyspareunia was evaluated by a questionnaire. The severity of dyspareunia recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.
Time frame: Baseline and Week 12
Population: The analysis was performed on a subgroup of the ITT Population (defined as all treated subjects with a baseline and at least one post-baseline efficacy assessment) who had self-identified moderate/severe dyspareunia as their Most Bothersome Symptom of vulvovaginal atrophy (VVA) and had ≤ 5% of Superficial Cells and a vaginal pH \> 5 on Day 1.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Co-primary Endpoint: Change From Baseline to Week 12 of Self-assessment of the Most Bothersome Symptom Dyspareunia | Week 12 | 2.3 units on a scale | Standard Error 0.18 |
| Placebo | Co-primary Endpoint: Change From Baseline to Week 12 of Self-assessment of the Most Bothersome Symptom Dyspareunia | Change from Baseline | -0.4 units on a scale | Standard Error 0.16 |
| Placebo | Co-primary Endpoint: Change From Baseline to Week 12 of Self-assessment of the Most Bothersome Symptom Dyspareunia | Baseline | 2.8 units on a scale | Standard Error 0.08 |
| 0.25% DHEA | Co-primary Endpoint: Change From Baseline to Week 12 of Self-assessment of the Most Bothersome Symptom Dyspareunia | Baseline | 2.8 units on a scale | Standard Error 0.08 |
| 0.25% DHEA | Co-primary Endpoint: Change From Baseline to Week 12 of Self-assessment of the Most Bothersome Symptom Dyspareunia | Change from Baseline | -1.3 units on a scale | Standard Error 0.2 |
| 0.25% DHEA | Co-primary Endpoint: Change From Baseline to Week 12 of Self-assessment of the Most Bothersome Symptom Dyspareunia | Week 12 | 1.4 units on a scale | Standard Error 0.22 |
| 0.50% DHEA | Co-primary Endpoint: Change From Baseline to Week 12 of Self-assessment of the Most Bothersome Symptom Dyspareunia | Week 12 | 1.1 units on a scale | Standard Error 0.22 |
| 0.50% DHEA | Co-primary Endpoint: Change From Baseline to Week 12 of Self-assessment of the Most Bothersome Symptom Dyspareunia | Baseline | 2.7 units on a scale | Standard Error 0.08 |
| 0.50% DHEA | Co-primary Endpoint: Change From Baseline to Week 12 of Self-assessment of the Most Bothersome Symptom Dyspareunia | Change from Baseline | -1.6 units on a scale | Standard Error 0.21 |
| 1.00% DHEA | Co-primary Endpoint: Change From Baseline to Week 12 of Self-assessment of the Most Bothersome Symptom Dyspareunia | Baseline | 2.6 units on a scale | Standard Error 0.09 |
| 1.00% DHEA | Co-primary Endpoint: Change From Baseline to Week 12 of Self-assessment of the Most Bothersome Symptom Dyspareunia | Change from Baseline | -1.4 units on a scale | Standard Error 0.18 |
| 1.00% DHEA | Co-primary Endpoint: Change From Baseline to Week 12 of Self-assessment of the Most Bothersome Symptom Dyspareunia | Week 12 | 1.2 units on a scale | Standard Error 0.2 |
Primary
Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Parabasal Cells)
The percentage of parabasal cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.
Time frame: Baseline and Week 12
Population: The analysis was performed on a subgroup of the ITT Population (defined as all treated subjects with a baseline and at least one post-baseline efficacy assessment) who had self-identified moderate/severe pain at intercourse (Dyspareunia) as their Most Bothersome Symptom of VVA and had ≤ 5% of Superficial Cells and a vaginal pH \> 5 on Day 1.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Parabasal Cells) | Baseline | 46.7 percentage of parabasal cells | Standard Error 8.64 |
| Placebo | Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Parabasal Cells) | Change from Baseline | 1.1 percentage of parabasal cells | Standard Error 3.62 |
| Placebo | Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Parabasal Cells) | Week 12 | 47.8 percentage of parabasal cells | Standard Error 7.52 |
| 0.25% DHEA | Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Parabasal Cells) | Baseline | 65.5 percentage of parabasal cells | Standard Error 6.92 |
| 0.25% DHEA | Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Parabasal Cells) | Change from Baseline | -48.6 percentage of parabasal cells | Standard Error 6.78 |
| 0.25% DHEA | Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Parabasal Cells) | Week 12 | 16.9 percentage of parabasal cells | Standard Error 3.66 |
| 0.50% DHEA | Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Parabasal Cells) | Week 12 | 11.0 percentage of parabasal cells | Standard Error 3.43 |
| 0.50% DHEA | Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Parabasal Cells) | Baseline | 53.4 percentage of parabasal cells | Standard Error 7.49 |
| 0.50% DHEA | Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Parabasal Cells) | Change from Baseline | -42.4 percentage of parabasal cells | Standard Error 7.36 |
| 1.00% DHEA | Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Parabasal Cells) | Baseline | 61.8 percentage of parabasal cells | Standard Error 6.88 |
| 1.00% DHEA | Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Parabasal Cells) | Change from Baseline | -54.9 percentage of parabasal cells | Standard Error 6.6 |
| 1.00% DHEA | Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Parabasal Cells) | Week 12 | 6.90 percentage of parabasal cells | Standard Error 1.77 |
Primary
Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Superficial Cells)
The percentage of superficial cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.
Time frame: Baseline and Week 12
Population: The analysis was performed on a subgroup of the ITT Population (defined as all treated subjects with a baseline and at least one post-baseline efficacy assessment) who had self-identified moderate/severe pain at intercourse (Dyspareunia) as their Most Bothersome Symptom of VVA and had ≤ 5% of Superficial Cells and a vaginal pH \> 5 on Day 1.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Superficial Cells) | Baseline | 0.6 percentage of superficial cells | Standard Error 0.2 |
| Placebo | Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Superficial Cells) | Change from Baseline | -0.1 percentage of superficial cells | Standard Error 0.23 |
| Placebo | Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Superficial Cells) | Week 12 | 0.5 percentage of superficial cells | Standard Error 0.19 |
| 0.25% DHEA | Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Superficial Cells) | Baseline | 0.4 percentage of superficial cells | Standard Error 0.15 |
| 0.25% DHEA | Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Superficial Cells) | Change from Baseline | 5.3 percentage of superficial cells | Standard Error 1.39 |
| 0.25% DHEA | Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Superficial Cells) | Week 12 | 5.7 percentage of superficial cells | Standard Error 1.33 |
| 0.50% DHEA | Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Superficial Cells) | Week 12 | 5.2 percentage of superficial cells | Standard Error 1.19 |
| 0.50% DHEA | Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Superficial Cells) | Baseline | 0.4 percentage of superficial cells | Standard Error 0.11 |
| 0.50% DHEA | Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Superficial Cells) | Change from Baseline | 4.8 percentage of superficial cells | Standard Error 1.2 |
| 1.00% DHEA | Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Superficial Cells) | Baseline | 0.4 percentage of superficial cells | Standard Error 0.16 |
| 1.00% DHEA | Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Superficial Cells) | Change from Baseline | 6.1 percentage of superficial cells | Standard Error 1.54 |
| 1.00% DHEA | Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Superficial Cells) | Week 12 | 6.5 percentage of superficial cells | Standard Error 1.53 |
Primary
Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal pH.
A pH strip was applied directly to the lateral wall of the vagina using forceps. The change in color of the pH indicator strip was compared to the color chart for pH evaluation. The corresponding pH value (with one decimal) was recorded. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.
Time frame: Baseline and Week 12
Population: The analysis was performed on a subgroup of the ITT Population (defined as all treated subjects with a baseline and at least one post-baseline efficacy assessment) who had self-identified moderate/severe pain at intercourse (Dyspareunia) as their Most Bothersome Symptom of VVA and had ≤ 5% of Superficial Cells and a vaginal pH \> 5 on Day 1.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal pH. | Baseline | 6.5 pH | Standard Error 0.13 |
| Placebo | Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal pH. | Change from Baseline | -0.5 pH | Standard Error 0.16 |
| Placebo | Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal pH. | Week 12 | 6.0 pH | Standard Error 0.22 |
| 0.25% DHEA | Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal pH. | Baseline | 6.6 pH | Standard Error 0.1 |
| 0.25% DHEA | Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal pH. | Change from Baseline | -1.1 pH | Standard Error 0.16 |
| 0.25% DHEA | Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal pH. | Week 12 | 5.5 pH | Standard Error 0.19 |
| 0.50% DHEA | Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal pH. | Week 12 | 5.2 pH | Standard Error 0.17 |
| 0.50% DHEA | Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal pH. | Baseline | 6.6 pH | Standard Error 0.09 |
| 0.50% DHEA | Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal pH. | Change from Baseline | -1.5 pH | Standard Error 0.18 |
| 1.00% DHEA | Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal pH. | Baseline | 6.5 pH | Standard Error 0.11 |
| 1.00% DHEA | Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal pH. | Change from Baseline | -1.4 pH | Standard Error 0.15 |
| 1.00% DHEA | Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal pH. | Week 12 | 5.1 pH | Standard Error 0.12 |
Secondary
Change From Baseline to Week 12 of Vaginal Color
To evaluate the aspect of the vaginal mucosa and the local tolerance to DHEA suppository, the vaginal color (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.
Time frame: Baseline and Week 12
Population: The analysis was performed on the ITT Population defined as all treated subjects (who received at least one dose) with a baseline and at least one post-baseline efficacy assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Week 12 of Vaginal Color | Baseline | 3.1 units on a scale | Standard Error 0.09 |
| Placebo | Change From Baseline to Week 12 of Vaginal Color | Change from Baseline | -0.5 units on a scale | Standard Error 0.11 |
| Placebo | Change From Baseline to Week 12 of Vaginal Color | Week 12 | 2.7 units on a scale | Standard Error 0.11 |
| 0.25% DHEA | Change From Baseline to Week 12 of Vaginal Color | Baseline | 3.0 units on a scale | Standard Error 0.1 |
| 0.25% DHEA | Change From Baseline to Week 12 of Vaginal Color | Change from Baseline | -1.0 units on a scale | Standard Error 0.13 |
| 0.25% DHEA | Change From Baseline to Week 12 of Vaginal Color | Week 12 | 2.0 units on a scale | Standard Error 0.12 |
| 0.50% DHEA | Change From Baseline to Week 12 of Vaginal Color | Week 12 | 1.8 units on a scale | Standard Error 0.11 |
| 0.50% DHEA | Change From Baseline to Week 12 of Vaginal Color | Baseline | 3.1 units on a scale | Standard Error 0.09 |
| 0.50% DHEA | Change From Baseline to Week 12 of Vaginal Color | Change from Baseline | -1.3 units on a scale | Standard Error 0.14 |
| 1.00% DHEA | Change From Baseline to Week 12 of Vaginal Color | Baseline | 3.1 units on a scale | Standard Error 0.07 |
| 1.00% DHEA | Change From Baseline to Week 12 of Vaginal Color | Change from Baseline | -1.5 units on a scale | Standard Error 0.12 |
| 1.00% DHEA | Change From Baseline to Week 12 of Vaginal Color | Week 12 | 1.6 units on a scale | Standard Error 0.1 |
Secondary
Change From Baseline to Week 12 of Vaginal Epithelial Integrity
To evaluate the aspect of the vaginal mucosa and the local tolerance to DHEA suppository, the vaginal epithelial integrity (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.
Time frame: Baseline and Week 12
Population: The analysis was performed on the ITT Population defined as all treated subjects (who received at least one dose) with a baseline and at least one post-baseline efficacy assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Week 12 of Vaginal Epithelial Integrity | Baseline | 2.8 units on a scale | Standard Error 0.13 |
| Placebo | Change From Baseline to Week 12 of Vaginal Epithelial Integrity | Change from Baseline | -0.4 units on a scale | Standard Error 0.12 |
| Placebo | Change From Baseline to Week 12 of Vaginal Epithelial Integrity | Week 12 | 2.4 units on a scale | Standard Error 0.13 |
| 0.25% DHEA | Change From Baseline to Week 12 of Vaginal Epithelial Integrity | Baseline | 2.7 units on a scale | Standard Error 0.12 |
| 0.25% DHEA | Change From Baseline to Week 12 of Vaginal Epithelial Integrity | Change from Baseline | -1.0 units on a scale | Standard Error 0.14 |
| 0.25% DHEA | Change From Baseline to Week 12 of Vaginal Epithelial Integrity | Week 12 | 1.7 units on a scale | Standard Error 0.11 |
| 0.50% DHEA | Change From Baseline to Week 12 of Vaginal Epithelial Integrity | Week 12 | 1.5 units on a scale | Standard Error 0.1 |
| 0.50% DHEA | Change From Baseline to Week 12 of Vaginal Epithelial Integrity | Baseline | 2.8 units on a scale | Standard Error 0.11 |
| 0.50% DHEA | Change From Baseline to Week 12 of Vaginal Epithelial Integrity | Change from Baseline | -1.3 units on a scale | Standard Error 0.12 |
| 1.00% DHEA | Change From Baseline to Week 12 of Vaginal Epithelial Integrity | Baseline | 2.7 units on a scale | Standard Error 0.11 |
| 1.00% DHEA | Change From Baseline to Week 12 of Vaginal Epithelial Integrity | Change from Baseline | -1.3 units on a scale | Standard Error 0.11 |
| 1.00% DHEA | Change From Baseline to Week 12 of Vaginal Epithelial Integrity | Week 12 | 1.4 units on a scale | Standard Error 0.09 |
Secondary
Change From Baseline to Week 12 of Vaginal Epithelial Surface Thickness
To evaluate the aspect of the vaginal mucosa and the local tolerance to DHEA suppository, the vaginal epithelial surface thickness(one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.
Time frame: Baseline and Week 12
Population: The analysis was performed on the ITT Population defined as all treated subjects (who received at least one dose) with a baseline and at least one post-baseline efficacy assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Week 12 of Vaginal Epithelial Surface Thickness | Baseline | 3.0 units on a scale | Standard Error 0.1 |
| Placebo | Change From Baseline to Week 12 of Vaginal Epithelial Surface Thickness | Change from Baseline | -0.4 units on a scale | Standard Error 0.1 |
| Placebo | Change From Baseline to Week 12 of Vaginal Epithelial Surface Thickness | Week 12 | 2.6 units on a scale | Standard Error 0.12 |
| 0.25% DHEA | Change From Baseline to Week 12 of Vaginal Epithelial Surface Thickness | Baseline | 2.9 units on a scale | Standard Error 0.08 |
| 0.25% DHEA | Change From Baseline to Week 12 of Vaginal Epithelial Surface Thickness | Change from Baseline | -1.0 units on a scale | Standard Error 0.12 |
| 0.25% DHEA | Change From Baseline to Week 12 of Vaginal Epithelial Surface Thickness | Week 12 | 1.9 units on a scale | Standard Error 0.11 |
| 0.50% DHEA | Change From Baseline to Week 12 of Vaginal Epithelial Surface Thickness | Week 12 | 1.8 units on a scale | Standard Error 0.11 |
| 0.50% DHEA | Change From Baseline to Week 12 of Vaginal Epithelial Surface Thickness | Baseline | 3.1 units on a scale | Standard Error 0.09 |
| 0.50% DHEA | Change From Baseline to Week 12 of Vaginal Epithelial Surface Thickness | Change from Baseline | -1.3 units on a scale | Standard Error 0.12 |
| 1.00% DHEA | Change From Baseline to Week 12 of Vaginal Epithelial Surface Thickness | Baseline | 3.0 units on a scale | Standard Error 0.08 |
| 1.00% DHEA | Change From Baseline to Week 12 of Vaginal Epithelial Surface Thickness | Change from Baseline | -1.4 units on a scale | Standard Error 0.12 |
| 1.00% DHEA | Change From Baseline to Week 12 of Vaginal Epithelial Surface Thickness | Week 12 | 1.6 units on a scale | Standard Error 0.1 |
Secondary
Change From Baseline to Week 12 of Vaginal Secretions
To evaluate the aspect of the vaginal mucosa and the local tolerance to DHEA suppository, the vaginal secretions (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy were analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.
Time frame: Baseline and Week 12
Population: The analysis was performed on the ITT Population defined as all treated subjects (who received at least one dose) with a baseline and at least one post-baseline efficacy assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Week 12 of Vaginal Secretions | Baseline | 3.1 units on a scale | Standard Error 0.09 |
| Placebo | Change From Baseline to Week 12 of Vaginal Secretions | Change from Baseline | -0.4 units on a scale | Standard Error 0.1 |
| Placebo | Change From Baseline to Week 12 of Vaginal Secretions | Week 12 | 2.7 units on a scale | Standard Error 0.12 |
| 0.25% DHEA | Change From Baseline to Week 12 of Vaginal Secretions | Baseline | 3.1 units on a scale | Standard Error 0.09 |
| 0.25% DHEA | Change From Baseline to Week 12 of Vaginal Secretions | Change from Baseline | -1.2 units on a scale | Standard Error 0.12 |
| 0.25% DHEA | Change From Baseline to Week 12 of Vaginal Secretions | Week 12 | 1.9 units on a scale | Standard Error 0.1 |
| 0.50% DHEA | Change From Baseline to Week 12 of Vaginal Secretions | Week 12 | 1.8 units on a scale | Standard Error 0.12 |
| 0.50% DHEA | Change From Baseline to Week 12 of Vaginal Secretions | Baseline | 3.2 units on a scale | Standard Error 0.09 |
| 0.50% DHEA | Change From Baseline to Week 12 of Vaginal Secretions | Change from Baseline | -1.4 units on a scale | Standard Error 0.13 |
| 1.00% DHEA | Change From Baseline to Week 12 of Vaginal Secretions | Baseline | 3.0 units on a scale | Standard Error 0.08 |
| 1.00% DHEA | Change From Baseline to Week 12 of Vaginal Secretions | Change from Baseline | -1.4 units on a scale | Standard Error 0.11 |
| 1.00% DHEA | Change From Baseline to Week 12 of Vaginal Secretions | Week 12 | 1.5 units on a scale | Standard Error 0.09 |