Vaginal Atrophy
Conditions
Keywords
Vulvovaginal atrophy (VVA), Vaginal atrophy, Atrophic vaginitis, prasterone, DHEA, Intrarosa
Brief summary
The purpose of this study is to confirm the efficacy of intravaginal prasterone (DHEA) on symptoms of vulvovaginal atrophy due to menopause and to collect further data on subjects exposed to intravaginal DHEA in order to meet the ICH E1 guideline requirements.
Interventions
DRUGPlacebo
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 80 Years
Healthy volunteers
No
Inclusion criteria
Main criteria: * Postmenopausal women (hysterectomized or not) * Women between 40 and 80 years of age * Women having ≤5% of superficial cells on vaginal smear at baseline * Women having a vaginal pH above 5 at baseline * Women who have self-identified moderate or severe symptom(s) of vaginal atrophy * Willing to participate in the study and sign an informed consent
Exclusion criteria
Main criteria: * Previous enrollment in EndoCeutics studies performed with intravaginal DHEA * Previous diagnosis of cancer, except skin cancer (non melanoma) * Clinically significant metabolic or endocrine disease (including diabetes mellitus) not controlled by medication * The administration of any investigational drug within 30 days of screening visit * Clinically significant abnormal serum biochemistry, urinalysis or hematology
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear | 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. |
| Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear | 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. |
| Change From Baseline to Week 12 in Vaginal pH | Baseline and Week 12 | A pH strip fixed on an Ayre spatula (or equivalent) was applied directly to the lateral wall of the vagina. 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. |
| Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Dyspareunia | Baseline and Week 12 | The severity of dyspareunia was evaluated by a questionnaire filled out by women. 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Week 12 in Severity of Vaginal Dryness | Baseline and Week 12 | The severity of vaginal dryness was evaluated by a questionnaire filled out by women. The severity of vaginal dryness 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. |
| Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color | Baseline and Week 12 | To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, 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. |
| Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions | Baseline and Week 12 | To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, 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 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity | Baseline and Week 12 | To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, 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 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness | Baseline and Week 12 | To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, 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. |
Countries
Canada, United States
Participant flow
Recruitment details
A total of 1226 subjects were screened at 38 medical/research sites located in the US (24 centers) and Canada (14 centers) and 558 subjects were randomized. The first subject first visit was on 11-FEB-2014 and the last subject last visit was on 06-JAN-2015.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo: Placebo vaginal ovule; daily dosing with one ovule for 12 weeks. | 180 |
| 0.50% Prasterone (DHEA) Prasterone (DHEA): Vaginal ovule containing 0.50% (6.5 mg) prasterone; daily dosing with one ovule for 12 weeks. | 374 |
| Total | 554 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 5 | 5 |
| Overall Study | Entry criteria not met/non-compliance | 2 | 3 |
| Overall Study | Lost to Follow-up | 2 | 3 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 8 |
Baseline characteristics
| Characteristic | Placebo | 0.50% Prasterone (DHEA) | Total |
|---|---|---|---|
| Age, Continuous | 59.55 years STANDARD_DEVIATION 5.75 | 59.51 years STANDARD_DEVIATION 6.78 | 59.53 years STANDARD_DEVIATION 6.46 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants | 4 Participants | 6 Participants |
| Race/Ethnicity, Customized Black or African American | 13 Participants | 28 Participants | 41 Participants |
| Race/Ethnicity, Customized Native hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized White Caucasian | 163 Participants | 338 Participants | 501 Participants |
| Sex/Gender, Customized Female | 180 Participants | 374 Participants | 554 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 10 / 180 | 24 / 374 |
| serious Total, serious adverse events | 0 / 180 | 5 / 374 |
Outcome results
Primary
Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear
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: Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear | Baseline | 51.66 Percentage of parabasal cells | Standard Error 3 |
| Placebo | Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear | Week 12 | 39.68 Percentage of parabasal cells | Standard Error 2.68 |
| Placebo | Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear | Change from Baseline to Week 12 | -11.98 Percentage of parabasal cells | Standard Error 2.36 |
| 0.50% Prasterone (DHEA) | Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear | Baseline | 54.25 Percentage of parabasal cells | Standard Error 2.14 |
| 0.50% Prasterone (DHEA) | Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear | Week 12 | 12.74 Percentage of parabasal cells | Standard Error 1.02 |
| 0.50% Prasterone (DHEA) | Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear | Change from Baseline to Week 12 | -41.51 Percentage of parabasal cells | Standard Error 2.01 |
Primary
Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear
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: Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear | Baseline | 1.04 Percentage of superficial cells | Standard Error 0.11 |
| Placebo | Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear | Week 12 | 2.78 Percentage of superficial cells | Standard Error 0.27 |
| Placebo | Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear | Change from Baseline to Week 12 | 1.75 Percentage of superficial cells | Standard Error 0.27 |
| 0.50% Prasterone (DHEA) | Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear | Baseline | 1.02 Percentage of superficial cells | Standard Error 0.08 |
| 0.50% Prasterone (DHEA) | Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear | Week 12 | 11.22 Percentage of superficial cells | Standard Error 0.56 |
| 0.50% Prasterone (DHEA) | Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear | Change from Baseline to Week 12 | 10.20 Percentage of superficial cells | Standard Error 0.57 |
Primary
Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Dyspareunia
The severity of dyspareunia was evaluated by a questionnaire filled out by women. 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: Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Dyspareunia | Baseline | 2.56 units on a scale | Standard Error 0.04 |
| Placebo | Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Dyspareunia | Week 12 | 1.50 units on a scale | Standard Error 0.08 |
| Placebo | Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Dyspareunia | Change from Baseline to Week 12 | -1.06 units on a scale | Standard Error 0.08 |
| 0.50% Prasterone (DHEA) | Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Dyspareunia | Baseline | 2.54 units on a scale | Standard Error 0.03 |
| 0.50% Prasterone (DHEA) | Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Dyspareunia | Week 12 | 1.13 units on a scale | Standard Error 0.05 |
| 0.50% Prasterone (DHEA) | Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Dyspareunia | Change from Baseline to Week 12 | -1.42 units on a scale | Standard Error 0.06 |
Primary
Change From Baseline to Week 12 in Vaginal pH
A pH strip fixed on an Ayre spatula (or equivalent) was applied directly to the lateral wall of the vagina. 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: Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Week 12 in Vaginal pH | Baseline | 6.32 units on a scale | Standard Error 0.05 |
| Placebo | Change From Baseline to Week 12 in Vaginal pH | Week 12 | 6.05 units on a scale | Standard Error 0.07 |
| Placebo | Change From Baseline to Week 12 in Vaginal pH | Change from Baseline to Week 12 | -0.27 units on a scale | Standard Error 0.06 |
| 0.50% Prasterone (DHEA) | Change From Baseline to Week 12 in Vaginal pH | Baseline | 6.34 units on a scale | Standard Error 0.04 |
| 0.50% Prasterone (DHEA) | Change From Baseline to Week 12 in Vaginal pH | Week 12 | 5.39 units on a scale | Standard Error 0.05 |
| 0.50% Prasterone (DHEA) | Change From Baseline to Week 12 in Vaginal pH | Change from Baseline to Week 12 | -0.94 units on a scale | Standard Error 0.05 |
Secondary
Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color
To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, 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: Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color | Baseline | 2.67 units on a scale | Standard Error 0.05 |
| Placebo | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color | Week 12 | 2.34 units on a scale | Standard Error 0.05 |
| Placebo | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color | Change from Baseline to Week 12 | -0.33 units on a scale | Standard Error 0.06 |
| 0.50% Prasterone (DHEA) | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color | Baseline | 2.75 units on a scale | Standard Error 0.03 |
| 0.50% Prasterone (DHEA) | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color | Week 12 | 2.03 units on a scale | Standard Error 0.04 |
| 0.50% Prasterone (DHEA) | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color | Change from Baseline to Week 12 | -0.73 units on a scale | Standard Error 0.05 |
Secondary
Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity
To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, 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: Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity | Baseline | 2.43 units on a scale | Standard Error 0.06 |
| Placebo | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity | Week 12 | 2.06 units on a scale | Standard Error 0.06 |
| Placebo | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity | Change from Baseline to Week 12 | -0.37 units on a scale | Standard Error 0.07 |
| 0.50% Prasterone (DHEA) | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity | Baseline | 2.45 units on a scale | Standard Error 0.05 |
| 0.50% Prasterone (DHEA) | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity | Week 12 | 1.75 units on a scale | Standard Error 0.04 |
| 0.50% Prasterone (DHEA) | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity | Change from Baseline to Week 12 | -0.69 units on a scale | Standard Error 0.05 |
Secondary
Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness
To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, 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: Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness | Baseline | 2.76 units on a scale | Standard Error 0.05 |
| Placebo | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness | Week 12 | 2.41 units on a scale | Standard Error 0.05 |
| Placebo | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness | Change from Baseline to Week 12 | -0.36 units on a scale | Standard Error 0.06 |
| 0.50% Prasterone (DHEA) | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness | Week 12 | 2.09 units on a scale | Standard Error 0.04 |
| 0.50% Prasterone (DHEA) | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness | Baseline | 2.83 units on a scale | Standard Error 0.03 |
| 0.50% Prasterone (DHEA) | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness | Change from Baseline to Week 12 | -0.74 units on a scale | Standard Error 0.05 |
Secondary
Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions
To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, 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: Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions | Change from Baseline to Week 12 | -0.39 units on a scale | Standard Error 0.06 |
| Placebo | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions | Baseline | 2.63 units on a scale | Standard Error 0.05 |
| Placebo | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions | Week 12 | 2.24 units on a scale | Standard Error 0.06 |
| 0.50% Prasterone (DHEA) | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions | Week 12 | 1.97 units on a scale | Standard Error 0.04 |
| 0.50% Prasterone (DHEA) | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions | Change from Baseline to Week 12 | -0.73 units on a scale | Standard Error 0.04 |
| 0.50% Prasterone (DHEA) | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions | Baseline | 2.70 units on a scale | Standard Error 0.04 |
Secondary
Change From Baseline to Week 12 in Severity of Vaginal Dryness
The severity of vaginal dryness was evaluated by a questionnaire filled out by women. The severity of vaginal dryness 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: Efficacy analyses on vaginal dryness were performed on a sub-group of the Intent to Treat (ITT) population (defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria) who had self-identified moderate to severe vaginal dryness at Baseline.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Week 12 in Severity of Vaginal Dryness | Baseline | 2.30 units on a scale | Standard Error 0.04 |
| Placebo | Change From Baseline to Week 12 in Severity of Vaginal Dryness | Week 12 | 1.13 units on a scale | Standard Error 0.08 |
| Placebo | Change From Baseline to Week 12 in Severity of Vaginal Dryness | Change from Baseline to Week 12 | -1.17 units on a scale | Standard Error 0.09 |
| 0.50% Prasterone (DHEA) | Change From Baseline to Week 12 in Severity of Vaginal Dryness | Baseline | 2.30 units on a scale | Standard Error 0.03 |
| 0.50% Prasterone (DHEA) | Change From Baseline to Week 12 in Severity of Vaginal Dryness | Week 12 | 0.86 units on a scale | Standard Error 0.05 |
| 0.50% Prasterone (DHEA) | Change From Baseline to Week 12 in Severity of Vaginal Dryness | Change from Baseline to Week 12 | -1.44 units on a scale | Standard Error 0.06 |