Trial Outcomes & Findings for Topical DHEA Against Vaginal Atrophy (NCT NCT01846442)
NCT ID: NCT01846442
Last Updated: 2017-08-29
Results Overview
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.
COMPLETED
PHASE3
218 participants
Baseline and Week 12
2017-08-29
Participant Flow
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.
Participant milestones
| Measure |
Placebo
Placebo: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.
|
0.25% DHEA
DHEA (0.25%): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
|
0.50% DHEA
DHEA (0.50%): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
|
1.00% DHEA
DHEA (1.00%): Vaginal suppository containing 1.0% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
54
|
54
|
56
|
54
|
|
Overall Study
Safety Population
|
54
|
53
|
56
|
54
|
|
Overall Study
ITT Population
|
53
|
53
|
56
|
54
|
|
Overall Study
COMPLETED
|
48
|
48
|
52
|
51
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
4
|
3
|
Reasons for withdrawal
| Measure |
Placebo
Placebo: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.
|
0.25% DHEA
DHEA (0.25%): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
|
0.50% DHEA
DHEA (0.50%): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
|
1.00% DHEA
DHEA (1.00%): Vaginal suppository containing 1.0% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
4
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
0
|
1
|
|
Overall Study
Left the city/Lost medication
|
1
|
0
|
1
|
1
|
Baseline Characteristics
Topical DHEA Against Vaginal Atrophy
Baseline characteristics by cohort
| Measure |
Placebo
n=54 Participants
Placebo: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.
|
0.25% DHEA
n=53 Participants
DHEA (0.25%): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
|
0.50% DHEA
n=56 Participants
DHEA (0.50%): Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
|
1.00% DHEA
n=54 Participants
DHEA (1.00%): Vaginal suppository containing 1.00% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
|
Total
n=217 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
59.00 years
STANDARD_DEVIATION 5.40 • n=5 Participants
|
57.68 years
STANDARD_DEVIATION 6.31 • n=7 Participants
|
58.45 years
STANDARD_DEVIATION 5.55 • n=5 Participants
|
59.44 years
STANDARD_DEVIATION 4.63 • n=4 Participants
|
58.65 years
STANDARD_DEVIATION 5.50 • n=21 Participants
|
|
Sex/Gender, Customized
Female
|
54 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
217 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White Caucasian
|
50 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
208 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=26 Participants
Placebo: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.
|
0.25% DHEA
n=29 Participants
DHEA (0.25%): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
|
0.50% DHEA
n=30 Participants
DHEA (0.50%): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
|
1.00% DHEA
n=29 Participants
DHEA (1.00%): Vaginal suppository containing 1.00% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
|
|---|---|---|---|---|
|
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
|
65.5 percentage of parabasal cells
Standard Error 6.92
|
53.4 percentage of parabasal cells
Standard Error 7.49
|
61.8 percentage of parabasal cells
Standard Error 6.88
|
|
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
|
16.9 percentage of parabasal cells
Standard Error 3.66
|
11.0 percentage of parabasal cells
Standard Error 3.43
|
6.90 percentage of parabasal cells
Standard Error 1.77
|
|
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
|
-48.6 percentage of parabasal cells
Standard Error 6.78
|
-42.4 percentage of parabasal cells
Standard Error 7.36
|
-54.9 percentage of parabasal cells
Standard Error 6.60
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=26 Participants
Placebo: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.
|
0.25% DHEA
n=29 Participants
DHEA (0.25%): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
|
0.50% DHEA
n=30 Participants
DHEA (0.50%): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
|
1.00% DHEA
n=29 Participants
DHEA (1.00%): Vaginal suppository containing 1.00% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
|
|---|---|---|---|---|
|
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
|
0.4 percentage of superficial cells
Standard Error 0.15
|
0.4 percentage of superficial cells
Standard Error 0.11
|
0.4 percentage of superficial cells
Standard Error 0.16
|
|
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
|
5.7 percentage of superficial cells
Standard Error 1.33
|
5.2 percentage of superficial cells
Standard Error 1.19
|
6.5 percentage of superficial cells
Standard Error 1.53
|
|
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
|
5.3 percentage of superficial cells
Standard Error 1.39
|
4.8 percentage of superficial cells
Standard Error 1.20
|
6.1 percentage of superficial cells
Standard Error 1.54
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=26 Participants
Placebo: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.
|
0.25% DHEA
n=29 Participants
DHEA (0.25%): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
|
0.50% DHEA
n=30 Participants
DHEA (0.50%): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
|
1.00% DHEA
n=29 Participants
DHEA (1.00%): Vaginal suppository containing 1.00% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
|
|---|---|---|---|---|
|
Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal pH.
Baseline
|
6.5 pH
Standard Error 0.13
|
6.6 pH
Standard Error 0.10
|
6.6 pH
Standard Error 0.09
|
6.5 pH
Standard Error 0.11
|
|
Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal pH.
Week 12
|
6.0 pH
Standard Error 0.22
|
5.5 pH
Standard Error 0.19
|
5.2 pH
Standard Error 0.17
|
5.1 pH
Standard Error 0.12
|
|
Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal pH.
Change from Baseline
|
-0.5 pH
Standard Error 0.16
|
-1.1 pH
Standard Error 0.16
|
-1.5 pH
Standard Error 0.18
|
-1.4 pH
Standard Error 0.15
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=26 Participants
Placebo: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.
|
0.25% DHEA
n=29 Participants
DHEA (0.25%): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
|
0.50% DHEA
n=30 Participants
DHEA (0.50%): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
|
1.00% DHEA
n=29 Participants
DHEA (1.00%): Vaginal suppository containing 1.00% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
|
|---|---|---|---|---|
|
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
|
2.8 units on a scale
Standard Error 0.08
|
2.7 units on a scale
Standard Error 0.08
|
2.6 units on a scale
Standard Error 0.09
|
|
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
|
1.4 units on a scale
Standard Error 0.22
|
1.1 units on a scale
Standard Error 0.22
|
1.2 units on a scale
Standard Error 0.20
|
|
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
|
-1.3 units on a scale
Standard Error 0.20
|
-1.6 units on a scale
Standard Error 0.21
|
-1.4 units on a scale
Standard Error 0.18
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=53 Participants
Placebo: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.
|
0.25% DHEA
n=53 Participants
DHEA (0.25%): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
|
0.50% DHEA
n=56 Participants
DHEA (0.50%): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
|
1.00% DHEA
n=54 Participants
DHEA (1.00%): Vaginal suppository containing 1.00% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline to Week 12 of Vaginal Secretions
Baseline
|
3.1 units on a scale
Standard Error 0.09
|
3.1 units on a scale
Standard Error 0.09
|
3.2 units on a scale
Standard Error 0.09
|
3.0 units on a scale
Standard Error 0.08
|
|
Change From Baseline to Week 12 of Vaginal Secretions
Week 12
|
2.7 units on a scale
Standard Error 0.12
|
1.9 units on a scale
Standard Error 0.10
|
1.8 units on a scale
Standard Error 0.12
|
1.5 units on a scale
Standard Error 0.09
|
|
Change From Baseline to Week 12 of Vaginal Secretions
Change from Baseline
|
-0.4 units on a scale
Standard Error 0.10
|
-1.2 units on a scale
Standard Error 0.12
|
-1.4 units on a scale
Standard Error 0.13
|
-1.4 units on a scale
Standard Error 0.11
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=53 Participants
Placebo: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.
|
0.25% DHEA
n=53 Participants
DHEA (0.25%): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
|
0.50% DHEA
n=56 Participants
DHEA (0.50%): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
|
1.00% DHEA
n=54 Participants
DHEA (1.00%): Vaginal suppository containing 1.00% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline to Week 12 of Vaginal Epithelial Integrity
Change from Baseline
|
-0.4 units on a scale
Standard Error 0.12
|
-1.0 units on a scale
Standard Error 0.14
|
-1.3 units on a scale
Standard Error 0.12
|
-1.3 units on a scale
Standard Error 0.11
|
|
Change From Baseline to Week 12 of Vaginal Epithelial Integrity
Baseline
|
2.8 units on a scale
Standard Error 0.13
|
2.7 units on a scale
Standard Error 0.12
|
2.8 units on a scale
Standard Error 0.11
|
2.7 units on a scale
Standard Error 0.11
|
|
Change From Baseline to Week 12 of Vaginal Epithelial Integrity
Week 12
|
2.4 units on a scale
Standard Error 0.13
|
1.7 units on a scale
Standard Error 0.11
|
1.5 units on a scale
Standard Error 0.10
|
1.4 units on a scale
Standard Error 0.09
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=53 Participants
Placebo: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.
|
0.25% DHEA
n=53 Participants
DHEA (0.25%): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
|
0.50% DHEA
n=56 Participants
DHEA (0.50%): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
|
1.00% DHEA
n=54 Participants
DHEA (1.00%): Vaginal suppository containing 1.00% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline to Week 12 of Vaginal Epithelial Surface Thickness
Baseline
|
3.0 units on a scale
Standard Error 0.10
|
2.9 units on a scale
Standard Error 0.08
|
3.1 units on a scale
Standard Error 0.09
|
3.0 units on a scale
Standard Error 0.08
|
|
Change From Baseline to Week 12 of Vaginal Epithelial Surface Thickness
Week 12
|
2.6 units on a scale
Standard Error 0.12
|
1.9 units on a scale
Standard Error 0.11
|
1.8 units on a scale
Standard Error 0.11
|
1.6 units on a scale
Standard Error 0.10
|
|
Change From Baseline to Week 12 of Vaginal Epithelial Surface Thickness
Change from Baseline
|
-0.4 units on a scale
Standard Error 0.10
|
-1.0 units on a scale
Standard Error 0.12
|
-1.3 units on a scale
Standard Error 0.12
|
-1.4 units on a scale
Standard Error 0.12
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=53 Participants
Placebo: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.
|
0.25% DHEA
n=53 Participants
DHEA (0.25%): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
|
0.50% DHEA
n=56 Participants
DHEA (0.50%): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
|
1.00% DHEA
n=54 Participants
DHEA (1.00%): Vaginal suppository containing 1.00% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline to Week 12 of Vaginal Color
Baseline
|
3.1 units on a scale
Standard Error 0.09
|
3.0 units on a scale
Standard Error 0.10
|
3.1 units on a scale
Standard Error 0.09
|
3.1 units on a scale
Standard Error 0.07
|
|
Change From Baseline to Week 12 of Vaginal Color
Week 12
|
2.7 units on a scale
Standard Error 0.11
|
2.0 units on a scale
Standard Error 0.12
|
1.8 units on a scale
Standard Error 0.11
|
1.6 units on a scale
Standard Error 0.10
|
|
Change From Baseline to Week 12 of Vaginal Color
Change from Baseline
|
-0.5 units on a scale
Standard Error 0.11
|
-1.0 units on a scale
Standard Error 0.13
|
-1.3 units on a scale
Standard Error 0.14
|
-1.5 units on a scale
Standard Error 0.12
|
Adverse Events
Placebo
0.25% DHEA
0.50% DHEA
1.00% DHEA
Serious adverse events
| Measure |
Placebo
n=54 participants at risk
Placebo: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.
|
0.25% DHEA
n=53 participants at risk
DHEA (0.25%): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
|
0.50% DHEA
n=56 participants at risk
DHEA (0.50%): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
|
1.00% DHEA
n=54 participants at risk
DHEA (1.00%): Vaginal suppository containing 1.00% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
|
|---|---|---|---|---|
|
Surgical and medical procedures
Cholecystectomy
|
0.00%
0/54 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
1.9%
1/53 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
0.00%
0/56 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
0.00%
0/54 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
|
Surgical and medical procedures
Appendicetomy
|
0.00%
0/54 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
0.00%
0/53 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
1.8%
1/56 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
0.00%
0/54 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
Other adverse events
| Measure |
Placebo
n=54 participants at risk
Placebo: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.
|
0.25% DHEA
n=53 participants at risk
DHEA (0.25%): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
|
0.50% DHEA
n=56 participants at risk
DHEA (0.50%): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
|
1.00% DHEA
n=54 participants at risk
DHEA (1.00%): Vaginal suppository containing 1.00% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
7.4%
4/54 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
3.8%
2/53 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
5.4%
3/56 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
9.3%
5/54 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.3%
5/54 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
3.8%
2/53 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
7.1%
4/56 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
9.3%
5/54 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.7%
2/54 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
3.8%
2/53 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
12.5%
7/56 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
1.9%
1/54 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
|
General disorders
Fatigue
|
1.9%
1/54 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
5.7%
3/53 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
7.1%
4/56 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
9.3%
5/54 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
|
Nervous system disorders
Headache
|
5.6%
3/54 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
11.3%
6/53 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
10.7%
6/56 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
7.4%
4/54 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
|
Reproductive system and breast disorders
Hot flush
|
7.4%
4/54 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
3.8%
2/53 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
7.1%
4/56 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
7.4%
4/54 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
|
Infections and infestations
Nasopharyngitis
|
9.3%
5/54 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
11.3%
6/53 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
7.1%
4/56 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
7.4%
4/54 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
|
Reproductive system and breast disorders
Vaginal discharge
|
5.6%
3/54 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
7.5%
4/53 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
10.7%
6/56 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
3.7%
2/54 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
|
Reproductive system and breast disorders
Vulvovaginal burning sensation
|
7.4%
4/54 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
1.9%
1/53 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
5.4%
3/56 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
7.4%
4/54 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
5.6%
3/54 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
7.5%
4/53 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
8.9%
5/56 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
9.3%
5/54 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Investigators shall provide to the SPONSOR 30 days prior to submission all documents for publication, presentation, etc that report any trial results. The SPONSOR shall have editorial rights on documents and the right to review/comment with regard to (1) proprietary information, (2) accuracy of the information, (3) correctness of the scientific evaluation/conclusions and (4) to ensure that the information is fairly balanced and in compliance with regulations.
- Publication restrictions are in place
Restriction type: OTHER