Vaginal Atrophy
Conditions
Keywords
Vulvar/vaginal atrophy, Atrophic Vaginitis, Dehydroepiandrosterone, DHEA, Prasterone, Vaginorm, Menopause, Intrarosa
Brief summary
The purpose of this Phase III trial is to confirm the efficacy of intravaginal dehydroepiandrosterone (DHEA) in postmenopausal women with vaginal atrophy.
Interventions
DRUGPlacebo
Placebo vaginal suppository
DRUGDHEA
Vaginal suppository containing 0.25% (3.25 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
Main Inclusion Criteria: * Postmenopausal women (hysterectomized or non-hysterectomized) * Women between 40 and 75 years of age. * Willing to participate in the study and sign an informed consent. * Women who have self-identified symptom(s)of vaginal atrophy. * For non-hysterectomized women, willing to have endometrial biopsy at screening and end of study. Main
Exclusion criteria
* Undiagnosed abnormal genital bleeding. * Hypertension equal to or above 140/90 mm Hg. * The administration of any investigational drug within 30 days of screening visit. * Endometrial hyperplasia, cancer or endometrial histology showing proliferative, secretory or menstrual type characteristics at histologic evaluation of endometrial biopsy performed at screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 cell 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 the 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 Superficial Cells in the Maturation Index of the Vaginal Smear | Baseline and Week 12 | The percentage of superficial cell 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 the 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 DHEA suppositories, 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 then analyzed using the 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 DHEA suppositories, 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 then 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 DHEA suppositories, 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 then 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 DHEA suppositories, 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 then 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 464 subjects were screened at 33 medical/research sites located in the US (24 centers) and Canada (9 centers) and 255 subjects were randomized. The first subject first visit was on 30-NOV-2010 and the last subject last visit was on 29-JUL-2011.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo: Placebo vaginal suppository | 80 |
| 0.25% DHEA DHEA: Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks. | 86 |
| 0.50% DHEA DHEA: Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks. | 87 |
| Total | 253 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 4 | 2 |
| Overall Study | Entry criteria not met/non-compliance | 4 | 7 | 6 |
| Overall Study | Lack of Efficacy | 0 | 1 | 1 |
| Overall Study | Physician Decision | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 0 | 2 |
Baseline characteristics
| Characteristic | Placebo | 0.25% DHEA | 0.50% DHEA | Total |
|---|---|---|---|---|
| Age, Continuous | 58.81 years STANDARD_DEVIATION 5.89 | 59.37 years STANDARD_DEVIATION 6.39 | 57.51 years STANDARD_DEVIATION 5.63 | 58.55 years STANDARD_DEVIATION 6.01 |
| Race/Ethnicity, Customized Asian | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 9 Participants | 4 Participants | 3 Participants | 16 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized White Caucasian | 69 Participants | 81 Participants | 83 Participants | 233 Participants |
| Sex/Gender, Customized Female | 80 Participants | 86 Participants | 87 Participants | 253 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 9 / 80 | 12 / 86 | 10 / 87 |
| serious Total, serious adverse events | 0 / 80 | 3 / 86 | 1 / 87 |
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 cell 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 the 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 | 68.48 Percentage of parabasal cells | Standard Error 4.41 |
| 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 | -1.62 Percentage of parabasal cells | Standard Error 3.22 |
| Placebo | Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear | Week 12 | 66.86 Percentage of parabasal cells | Standard Error 4.37 |
| 0.25% DHEA | Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear | Week 12 | 28.43 Percentage of parabasal cells | Standard Error 3.62 |
| 0.25% 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 | -37.29 Percentage of parabasal cells | Standard Error 4.16 |
| 0.25% DHEA | Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear | Baseline | 65.72 Percentage of parabasal cells | Standard Error 4.56 |
| 0.50% 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 | -47.40 Percentage of parabasal cells | Standard Error 4.72 |
| 0.50% DHEA | Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear | Week 12 | 17.65 Percentage of parabasal cells | Standard Error 2.87 |
| 0.50% DHEA | Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear | Baseline | 65.05 Percentage of parabasal cells | Standard Error 4.63 |
Primary
Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear
The percentage of superficial cell 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 the 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 | Week 12 | 1.64 Percentage of superficial cells | Standard Error 0.33 |
| Placebo | Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear | Baseline | 0.73 Percentage of superficial cells | Standard Error 0.15 |
| 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 | 0.91 Percentage of superficial cells | Standard Error 0.31 |
| 0.25% DHEA | Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear | Week 12 | 5.43 Percentage of superficial cells | Standard Error 0.57 |
| 0.25% DHEA | Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear | Baseline | 0.68 Percentage of superficial cells | Standard Error 0.13 |
| 0.25% 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 | 4.75 Percentage of superficial cells | Standard Error 0.58 |
| 0.50% DHEA | Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear | Baseline | 0.68 Percentage of superficial cells | Standard Error 0.12 |
| 0.50% 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 | 5.62 Percentage of superficial cells | Standard Error 0.61 |
| 0.50% DHEA | Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear | Week 12 | 6.30 Percentage of superficial cells | Standard Error 0.59 |
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 | 2.58 units on a scale | Standard Error 0.06 |
| Placebo | Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Dyspareunia | Week 12 | 1.71 units on a scale | Standard Error 0.11 |
| Placebo | Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Dyspareunia | Change from Baseline to Week 12 | -0.87 units on a scale | Standard Error 0.11 |
| 0.25% DHEA | Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Dyspareunia | Change from Baseline to Week 12 | -1.01 units on a scale | Standard Error 0.11 |
| 0.25% DHEA | Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Dyspareunia | Baseline | 2.56 units on a scale | Standard Error 0.06 |
| 0.25% DHEA | Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Dyspareunia | Week 12 | 1.54 units on a scale | Standard Error 0.12 |
| 0.50% DHEA | Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Dyspareunia | Week 12 | 1.36 units on a scale | Standard Error 0.12 |
| 0.50% DHEA | Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Dyspareunia | Baseline | 2.63 units on a scale | Standard Error 0.05 |
| 0.50% DHEA | Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Dyspareunia | Change from Baseline to Week 12 | -1.27 units on a scale | Standard Error 0.11 |
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 | 6.51 units on a scale | Standard Error 0.07 |
| Placebo | Change From Baseline to Week 12 in Vaginal pH | Change from Baseline to Week 12 | -0.21 units on a scale | Standard Error 0.08 |
| Placebo | Change From Baseline to Week 12 in Vaginal pH | Week 12 | 6.31 units on a scale | Standard Error 0.09 |
| 0.25% DHEA | Change From Baseline to Week 12 in Vaginal pH | Baseline | 6.48 units on a scale | Standard Error 0.07 |
| 0.25% DHEA | Change From Baseline to Week 12 in Vaginal pH | Week 12 | 5.70 units on a scale | Standard Error 0.11 |
| 0.25% DHEA | Change From Baseline to Week 12 in Vaginal pH | Change from Baseline to Week 12 | -0.77 units on a scale | Standard Error 0.1 |
| 0.50% DHEA | Change From Baseline to Week 12 in Vaginal pH | Change from Baseline to Week 12 | -1.04 units on a scale | Standard Error 0.11 |
| 0.50% DHEA | Change From Baseline to Week 12 in Vaginal pH | Baseline | 6.47 units on a scale | Standard Error 0.07 |
| 0.50% DHEA | Change From Baseline to Week 12 in Vaginal pH | Week 12 | 5.43 units on a scale | Standard Error 0.1 |
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 DHEA suppositories, 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 then analyzed using the 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: 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 | 2.82 units on a scale | Standard Error 0.08 |
| Placebo | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color | Week 12 | 2.56 units on a scale | Standard Error 0.08 |
| Placebo | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color | Change from Baseline to Week 12 | -0.26 units on a scale | Standard Error 0.07 |
| 0.25% DHEA | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color | Week 12 | 2.27 units on a scale | Standard Error 0.1 |
| 0.25% DHEA | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color | Change from Baseline to Week 12 | -0.67 units on a scale | Standard Error 0.09 |
| 0.25% DHEA | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color | Baseline | 2.94 units on a scale | Standard Error 0.08 |
| 0.50% DHEA | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color | Week 12 | 2.05 units on a scale | Standard Error 0.09 |
| 0.50% DHEA | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color | Change from Baseline to Week 12 | -0.89 units on a scale | Standard Error 0.1 |
| 0.50% DHEA | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color | Baseline | 2.94 units on a scale | Standard Error 0.08 |
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 DHEA suppositories, 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 then 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: 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 | Change from Baseline to Week 12 | -0.45 units on a scale | Standard Error 0.08 |
| Placebo | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity | Baseline | 2.58 units on a scale | Standard Error 0.09 |
| Placebo | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity | Week 12 | 2.13 units on a scale | Standard Error 0.09 |
| 0.25% DHEA | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity | Change from Baseline to Week 12 | -0.65 units on a scale | Standard Error 0.09 |
| 0.25% DHEA | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity | Baseline | 2.57 units on a scale | Standard Error 0.1 |
| 0.25% DHEA | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity | Week 12 | 1.92 units on a scale | Standard Error 0.09 |
| 0.50% DHEA | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity | Change from Baseline to Week 12 | -0.88 units on a scale | Standard Error 0.1 |
| 0.50% DHEA | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity | Baseline | 2.57 units on a scale | Standard Error 0.1 |
| 0.50% DHEA | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity | Week 12 | 1.69 units on a scale | Standard Error 0.09 |
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 DHEA suppositories, 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 then 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: 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 | Week 12 | 2.57 units on a scale | Standard Error 0.08 |
| Placebo | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness | Baseline | 2.91 units on a scale | Standard Error 0.07 |
| 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 | -0.34 units on a scale | Standard Error 0.07 |
| 0.25% DHEA | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness | Week 12 | 2.32 units on a scale | Standard Error 0.09 |
| 0.25% DHEA | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness | Baseline | 2.90 units on a scale | Standard Error 0.08 |
| 0.25% 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 | -0.58 units on a scale | Standard Error 0.09 |
| 0.50% DHEA | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness | Baseline | 2.89 units on a scale | Standard Error 0.07 |
| 0.50% 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 | -0.75 units on a scale | Standard Error 0.09 |
| 0.50% DHEA | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness | Week 12 | 2.14 units on a scale | Standard Error 0.08 |
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 DHEA suppositories, 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 then 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: 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 | Week 12 | 2.36 units on a scale | Standard Error 0.08 |
| Placebo | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions | Baseline | 2.78 units on a scale | Standard Error 0.08 |
| Placebo | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions | Change from Baseline to Week 12 | -0.42 units on a scale | Standard Error 0.08 |
| 0.25% DHEA | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions | Week 12 | 2.10 units on a scale | Standard Error 0.09 |
| 0.25% DHEA | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions | Baseline | 2.81 units on a scale | Standard Error 0.07 |
| 0.25% DHEA | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions | Change from Baseline to Week 12 | -0.71 units on a scale | Standard Error 0.09 |
| 0.50% DHEA | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions | Baseline | 2.83 units on a scale | Standard Error 0.08 |
| 0.50% DHEA | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions | Change from Baseline to Week 12 | -0.88 units on a scale | Standard Error 0.11 |
| 0.50% DHEA | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions | Week 12 | 1.95 units on a scale | Standard Error 0.08 |
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 have 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 | Week 12 | 1.32 units on a scale | Standard Error 0.12 |
| Placebo | Change From Baseline to Week 12 in Severity of Vaginal Dryness | Baseline | 2.33 units on a scale | Standard Error 0.06 |
| Placebo | Change From Baseline to Week 12 in Severity of Vaginal Dryness | Change from Baseline to Week 12 | -1.02 units on a scale | Standard Error 0.14 |
| 0.25% DHEA | Change From Baseline to Week 12 in Severity of Vaginal Dryness | Week 12 | 0.91 units on a scale | Standard Error 0.1 |
| 0.25% DHEA | Change From Baseline to Week 12 in Severity of Vaginal Dryness | Baseline | 2.20 units on a scale | Standard Error 0.05 |
| 0.25% DHEA | Change From Baseline to Week 12 in Severity of Vaginal Dryness | Change from Baseline to Week 12 | -1.29 units on a scale | Standard Error 0.11 |
| 0.50% DHEA | Change From Baseline to Week 12 in Severity of Vaginal Dryness | Baseline | 2.37 units on a scale | Standard Error 0.06 |
| 0.50% DHEA | Change From Baseline to Week 12 in Severity of Vaginal Dryness | Change from Baseline to Week 12 | -1.45 units on a scale | Standard Error 0.12 |
| 0.50% DHEA | Change From Baseline to Week 12 in Severity of Vaginal Dryness | Week 12 | 0.92 units on a scale | Standard Error 0.1 |