Trial · NCT01358760
Dehydroepiandrosterone (DHEA) Against Vaginal Atrophy
NCT01358760, Phase 3, Completed, EndoCeutics Inc.; results first posted 2017-06-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Dehydroepiandrosterone (DHEA) Against Vaginal Atrophy. Trials, record NCT01358760. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01358760
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dehydroepiandrosterone (DHEA) Against Vaginal Atrophy
- NCT number
- NCT01358760
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 450 participants, actual
- Lead sponsor
- EndoCeutics Inc.
- Conditions
- Vaginal Atrophy
- Interventions
- Placebo, DHEA, DHEA
- First posted
- 2011-05-24
- Last updated
- 2017-06-12
- Results first posted
- 2017-06-12
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness | Baseline and Week 12 | 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. |
| Secondary | Change From Baseline to Week 12 in Severity 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear | Baseline and Week 12 | 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. | percentage of parabasal cells | MEAN |
| PRIMARY | Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear | Baseline and Week 12 | 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. | percentage of superficial cells | MEAN |
| PRIMARY | Change From Baseline to Week 12 in Vaginal pH | Baseline and Week 12 | 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. | pH units | MEAN |
| PRIMARY | Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness | Baseline and Week 12 | 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. | Severity score | MEAN |
| SECONDARY | Change From Baseline to Week 12 in Severity of Dyspareunia | Baseline and Week 12 | 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. | Severity score | MEAN |
| SECONDARY | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions | Baseline and Week 12 | 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. | Severity score | MEAN |
| SECONDARY | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity | Baseline and Week 12 | 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. | Severity score | MEAN |
| SECONDARY | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness | Baseline and Week 12 | 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. | Severity score | MEAN |
| SECONDARY | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color | Baseline and Week 12 | 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. | Severity score | MEAN |
Source ClinicalTrials.gov
Results by group81
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear | Placebo | Baseline | 60.66 | Standard Error 3.40 | percentage of parabasal cells |
| Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear | 0.25% DHEA | Baseline | 56.74 | Standard Error 3.69 | percentage of parabasal cells |
| Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear | 0.50% DHEA | Baseline | 59.54 | Standard Error 3.41 | percentage of parabasal cells |
| Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear | Placebo | Week 12 | 62.22 | Standard Error 3.49 | percentage of parabasal cells |
| Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear | 0.25% DHEA | Week 12 | 39.23 | Standard Error 3.15 | percentage of parabasal cells |
| Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear | 0.50% DHEA | Week 12 | 33.02 | Standard Error 3.09 | percentage of parabasal cells |
| Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear | Placebo | Change from Baseline to Week 12 | 1.56 | Standard Error 1.98 | percentage of parabasal cells |
| Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear | 0.25% DHEA | Change from Baseline to Week 12 | -17.51 | Standard Error 2.74 | percentage of parabasal cells |
| Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear | 0.50% DHEA | Change from Baseline to Week 12 | -26.52 | Standard Error 2.94 | percentage of parabasal cells |
| Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear | Placebo | Baseline | 0.97 | Standard Error 0.13 | percentage of superficial cells |
1 to 10 of 81Source ClinicalTrials.gov
See all 81 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 152 | |
| Overall Study | STARTED | 0.25% DHEA | 148 | |
| Overall Study | STARTED | 0.50% DHEA | 150 | |
| Overall Study | Safety Population | Placebo | 150 | |
| Overall Study | Safety Population | 0.25% DHEA | 143 | |
| Overall Study | Safety Population | 0.50% DHEA | 148 | |
| Overall Study | ITT Population | Placebo | 139 | |
| Overall Study | ITT Population | 0.25% DHEA | 134 | |
| Overall Study | ITT Population | 0.50% DHEA | 134 | |
| Overall Study | COMPLETED | Placebo | 130 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events27
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | Placebo | 10 | 150 | |
| other | Nasopharyngitis | Infections and infestations | 0.25% DHEA | 7 | 143 | |
| other | Nasopharyngitis | Infections and infestations | 0.50% DHEA | 9 | 148 | |
| other | Urinary tract infection | Infections and infestations | Placebo | 9 | 150 | |
| other | Urinary tract infection | Infections and infestations | 0.25% DHEA | 10 | 143 | |
| other | Urinary tract infection | Infections and infestations | 0.50% DHEA | 14 | 148 | |
| serious | Gastritis erosive | Gastrointestinal disorders | Placebo | 1 | 150 | |
| serious | Gastritis erosive | Gastrointestinal disorders | 0.25% DHEA | 0 | 143 | |
| serious | Gastritis erosive | Gastrointestinal disorders | 0.50% DHEA | 0 | 148 | |
| serious | Pancreatitis | Gastrointestinal disorders | Placebo | 1 | 150 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | 0.25% DHEA | ||
| Total, all-cause mortality | 0.50% DHEA | ||
| Total, other adverse events | Placebo | 19 | 150 |
| Total, other adverse events | 0.25% DHEA | 17 | 143 |
| Total, other adverse events | 0.50% DHEA | 23 | 148 |
| Total, serious adverse events | Placebo | 5 | 150 |
| Total, serious adverse events | 0.25% DHEA | 1 | 143 |
| Total, serious adverse events | 0.50% DHEA | 1 | 148 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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