Trial Outcomes & Findings for Dehydroepiandrosterone (DHEA) Against Vaginal Atrophy (NCT NCT01358760)
NCT ID: NCT01358760
Last Updated: 2017-06-12
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
450 participants
Baseline and Week 12
2017-06-12
Participant Flow
A total of 897 subjects were screened at 42 medical/research sites located in the US (32 centers) and Canada (10 centers) and 450 subjects were randomized. The first subject first visit was on 21-JUN-2011 and the last subject last visit was on 12-APR-2012.
Participant milestones
| Measure |
Placebo
Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
|
0.25% DHEA
DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
|
0.50% DHEA
DHEA (prasterone): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
152
|
148
|
150
|
|
Overall Study
Safety Population
|
150
|
143
|
148
|
|
Overall Study
ITT Population
|
139
|
134
|
134
|
|
Overall Study
COMPLETED
|
130
|
128
|
125
|
|
Overall Study
NOT COMPLETED
|
22
|
20
|
25
|
Reasons for withdrawal
| Measure |
Placebo
Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
|
0.25% DHEA
DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
|
0.50% DHEA
DHEA (prasterone): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
4
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
5
|
3
|
2
|
|
Overall Study
Physician Decision
|
1
|
0
|
1
|
|
Overall Study
Entry criteria not met/Non-compliance
|
12
|
12
|
16
|
Baseline Characteristics
Dehydroepiandrosterone (DHEA) Against Vaginal Atrophy
Baseline characteristics by cohort
| Measure |
Placebo
n=150 Participants
Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
|
0.25% DHEA
n=143 Participants
DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
|
0.50% DHEA
n=148 Participants
DHEA (prasterone): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
|
Total
n=441 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
57.59 years
STANDARD_DEVIATION 6.47 • n=93 Participants
|
58.41 years
STANDARD_DEVIATION 6.02 • n=4 Participants
|
58.33 years
STANDARD_DEVIATION 6.16 • n=27 Participants
|
58.11 years
STANDARD_DEVIATION 6.22 • n=483 Participants
|
|
Sex/Gender, Customized
Female
|
150 Participants
n=93 Participants
|
143 Participants
n=4 Participants
|
148 Participants
n=27 Participants
|
441 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
White caucasian
|
135 Participants
n=93 Participants
|
132 Participants
n=4 Participants
|
131 Participants
n=27 Participants
|
398 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
12 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
34 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: 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.
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=139 Participants
Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
|
0.25% DHEA
n=134 Participants
DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
|
0.50% DHEA
n=134 Participants
DHEA (prasterone): Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
|
|---|---|---|---|
|
Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear
Baseline
|
60.66 percentage of parabasal cells
Standard Error 3.40
|
56.74 percentage of parabasal cells
Standard Error 3.69
|
59.54 percentage of parabasal cells
Standard Error 3.41
|
|
Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear
Week 12
|
62.22 percentage of parabasal cells
Standard Error 3.49
|
39.23 percentage of parabasal cells
Standard Error 3.15
|
33.02 percentage of parabasal cells
Standard Error 3.09
|
|
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
|
1.56 percentage of parabasal cells
Standard Error 1.98
|
-17.51 percentage of parabasal cells
Standard Error 2.74
|
-26.52 percentage of parabasal cells
Standard Error 2.94
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: 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.
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=139 Participants
Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
|
0.25% DHEA
n=134 Participants
DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
|
0.50% DHEA
n=134 Participants
DHEA (prasterone): Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
|
|---|---|---|---|
|
Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear
Baseline
|
0.97 percentage of superficial cells
Standard Error 0.13
|
1.12 percentage of superficial cells
Standard Error 0.13
|
0.93 percentage of superficial cells
Standard Error 0.11
|
|
Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear
Week 12
|
1.80 percentage of superficial cells
Standard Error 0.29
|
3.43 percentage of superficial cells
Standard Error 0.34
|
3.58 percentage of superficial cells
Standard Error 0.41
|
|
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
|
0.83 percentage of superficial cells
Standard Error 0.26
|
2.31 percentage of superficial cells
Standard Error 0.32
|
2.66 percentage of superficial cells
Standard Error 0.41
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=139 Participants
Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
|
0.25% DHEA
n=134 Participants
DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
|
0.50% DHEA
n=134 Participants
DHEA (prasterone): Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
|
|---|---|---|---|
|
Change From Baseline to Week 12 in Vaginal pH
Baseline
|
6.34 pH units
Standard Error 0.05
|
6.27 pH units
Standard Error 0.06
|
6.29 pH units
Standard Error 0.06
|
|
Change From Baseline to Week 12 in Vaginal pH
Week 12
|
6.06 pH units
Standard Error 0.08
|
5.69 pH units
Standard Error 0.09
|
5.67 pH units
Standard Error 0.08
|
|
Change From Baseline to Week 12 in Vaginal pH
Change from Baseline to Week 12
|
-0.28 pH units
Standard Error 0.06
|
-0.58 pH units
Standard Error 0.07
|
-0.62 pH units
Standard Error 0.07
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: 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.
The severity of vaginal dryness was evaluated by a questionnaire filled out by women. The severity of 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.
Outcome measures
| Measure |
Placebo
n=139 Participants
Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
|
0.25% DHEA
n=134 Participants
DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
|
0.50% DHEA
n=134 Participants
DHEA (prasterone): Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
|
|---|---|---|---|
|
Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness
Baseline
|
2.38 Severity score
Standard Error 0.04
|
2.37 Severity score
Standard Error 0.04
|
2.35 Severity score
Standard Error 0.04
|
|
Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness
Week 12
|
1.27 Severity score
Standard Error 0.07
|
1.10 Severity score
Standard Error 0.07
|
1.13 Severity score
Standard Error 0.08
|
|
Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness
Change from Baseline to Week 12
|
-1.12 Severity score
Standard Error 0.08
|
-1.28 Severity score
Standard Error 0.08
|
-1.22 Severity score
Standard Error 0.08
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Efficacy analyses on dyspareunia were performed on a subgroup 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 dyspareunia at Baseline.
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.
Outcome measures
| Measure |
Placebo
n=99 Participants
Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
|
0.25% DHEA
n=93 Participants
DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
|
0.50% DHEA
n=100 Participants
DHEA (prasterone): Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
|
|---|---|---|---|
|
Change From Baseline to Week 12 in Severity of Dyspareunia
Baseline
|
2.56 Severity score
Standard Error 0.05
|
2.58 Severity score
Standard Error 0.05
|
2.60 Severity score
Standard Error 0.05
|
|
Change From Baseline to Week 12 in Severity of Dyspareunia
Week 12
|
1.78 Severity score
Standard Error 0.11
|
1.48 Severity score
Standard Error 0.12
|
1.54 Severity score
Standard Error 0.10
|
|
Change From Baseline to Week 12 in Severity of Dyspareunia
Change from Baseline to Week 12
|
-0.78 Severity score
Standard Error 0.10
|
-1.10 Severity score
Standard Error 0.12
|
-1.06 Severity score
Standard Error 0.10
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=139 Participants
Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
|
0.25% DHEA
n=134 Participants
DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
|
0.50% DHEA
n=134 Participants
DHEA (prasterone): Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
|
|---|---|---|---|
|
Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions
Baseline
|
2.71 Severity score
Standard Error 0.05
|
2.55 Severity score
Standard Error 0.06
|
2.55 Severity score
Standard Error 0.06
|
|
Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions
Week 12
|
2.33 Severity score
Standard Error 0.06
|
2.07 Severity score
Standard Error 0.08
|
2.07 Severity score
Standard Error 0.06
|
|
Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions
Change from Baseline to Week 12
|
-0.38 Severity score
Standard Error 0.05
|
-0.48 Severity score
Standard Error 0.08
|
-0.48 Severity score
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=139 Participants
Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
|
0.25% DHEA
n=134 Participants
DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
|
0.50% DHEA
n=134 Participants
DHEA (prasterone): Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
|
|---|---|---|---|
|
Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity
Baseline
|
2.32 Severity score
Standard Error 0.07
|
2.19 Severity score
Standard Error 0.07
|
2.19 Severity score
Standard Error 0.08
|
|
Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity
Week 12
|
1.94 Severity score
Standard Error 0.07
|
1.74 Severity score
Standard Error 0.07
|
1.69 Severity score
Standard Error 0.07
|
|
Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity
Change from Baseline to Week 12
|
-0.38 Severity score
Standard Error 0.06
|
-0.46 Severity score
Standard Error 0.07
|
-0.50 Severity score
Standard Error 0.08
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=139 Participants
Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
|
0.25% DHEA
n=134 Participants
DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
|
0.50% DHEA
n=134 Participants
DHEA (prasterone): Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
|
|---|---|---|---|
|
Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness
Baseline
|
2.78 Severity score
Standard Error 0.06
|
2.66 Severity score
Standard Error 0.06
|
2.72 Severity score
Standard Error 0.06
|
|
Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness
Week 12
|
2.40 Severity score
Standard Error 0.07
|
2.25 Severity score
Standard Error 0.07
|
2.16 Severity score
Standard Error 0.06
|
|
Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness
Change from Baseline to Week 12
|
-0.38 Severity score
Standard Error 0.06
|
-0.40 Severity score
Standard Error 0.07
|
-0.56 Severity score
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=139 Participants
Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
|
0.25% DHEA
n=134 Participants
DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
|
0.50% DHEA
n=134 Participants
DHEA (prasterone): Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
|
|---|---|---|---|
|
Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color
Baseline
|
2.66 Severity score
Standard Error 0.05
|
2.60 Severity score
Standard Error 0.06
|
2.65 Severity score
Standard Error 0.06
|
|
Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color
Week 12
|
2.31 Severity score
Standard Error 0.07
|
2.16 Severity score
Standard Error 0.07
|
2.12 Severity score
Standard Error 0.06
|
|
Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color
Change from Baseline to Week 12
|
-0.35 Severity score
Standard Error 0.06
|
-0.45 Severity score
Standard Error 0.07
|
-0.53 Severity score
Standard Error 0.07
|
Adverse Events
Placebo
0.25% DHEA
0.50% DHEA
Serious adverse events
| Measure |
Placebo
n=150 participants at risk
Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
|
0.25% DHEA
n=143 participants at risk
DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
|
0.50% DHEA
n=148 participants at risk
DHEA (prasterone): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
|
|---|---|---|---|
|
Gastrointestinal disorders
Gastritis erosive
|
0.67%
1/150 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
0.00%
0/143 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
0.00%
0/148 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
|
Gastrointestinal disorders
Pancreatitis
|
0.67%
1/150 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
0.00%
0/143 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
0.00%
0/148 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.67%
1/150 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
0.00%
0/143 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
0.00%
0/148 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
|
Infections and infestations
Cellulitis
|
0.00%
0/150 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
0.00%
0/143 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
0.68%
1/148 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
|
Nervous system disorders
Movement disorder
|
0.00%
0/150 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
0.70%
1/143 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
0.00%
0/148 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
|
Psychiatric disorders
Stress
|
0.67%
1/150 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
0.00%
0/143 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
0.00%
0/148 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.67%
1/150 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
0.00%
0/143 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
0.00%
0/148 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
Other adverse events
| Measure |
Placebo
n=150 participants at risk
Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
|
0.25% DHEA
n=143 participants at risk
DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
|
0.50% DHEA
n=148 participants at risk
DHEA (prasterone): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
6.7%
10/150 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
4.9%
7/143 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
6.1%
9/148 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
|
Infections and infestations
Urinary tract infection
|
6.0%
9/150 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
7.0%
10/143 • From Baseline to Week 12 (+ 30-day follow-up period after last dose)
|
9.5%
14/148 • 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