Trial · NCT01256684
DHEA Against Vaginal Atrophy - 3-Month Efficacy Study
NCT01256684, Phase 3, Completed, EndoCeutics Inc.; results first posted 2017-04-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. DHEA Against Vaginal Atrophy - 3-Month Efficacy Study. Trials, record NCT01256684. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01256684
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- DHEA Against Vaginal Atrophy - 3-Month Efficacy Study
- NCT number
- NCT01256684
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 255 participants, actual
- Lead sponsor
- EndoCeutics Inc.
- Conditions
- Vaginal Atrophy
- Interventions
- Placebo, DHEA, DHEA
- First posted
- 2010-12-08
- Last updated
- 2017-06-26
- Results first posted
- 2017-04-25
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 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. |
| 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 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. |
| 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 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 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. |
| 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 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. |
| 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 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. |
| 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 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. |
| 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 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. |
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. | units on a scale | MEAN |
| PRIMARY | Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Dyspareunia | 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. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to Week 12 in Severity of Vaginal Dryness | Baseline and Week 12 | 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. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions | Baseline and Week 12 | 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. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity | Baseline and Week 12 | 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. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness | Baseline and Week 12 | 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. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color | Baseline and Week 12 | 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. | units on a scale | 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 | 68.48 | Standard Error 4.41 | 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 | 65.72 | Standard Error 4.56 | 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 | 65.05 | Standard Error 4.63 | 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 | 66.86 | Standard Error 4.37 | 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 | 28.43 | Standard Error 3.62 | 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 | 17.65 | Standard Error 2.87 | 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 | -1.62 | Standard Error 3.22 | 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 | -37.29 | Standard Error 4.16 | 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 | -47.40 | Standard Error 4.72 | 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 | 0.73 | Standard Error 0.15 | 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 | 81 | |
| Overall Study | STARTED | 0.25% DHEA | 87 | |
| Overall Study | STARTED | 0.50% DHEA | 87 | |
| Overall Study | Safety Population | Placebo | 80 | |
| Overall Study | Safety Population | 0.25% DHEA | 86 | |
| Overall Study | Safety Population | 0.50% DHEA | 87 | |
| Overall Study | ITT Population | Placebo | 77 | |
| Overall Study | ITT Population | 0.25% DHEA | 79 | |
| Overall Study | ITT Population | 0.50% DHEA | 81 | |
| Overall Study | COMPLETED | Placebo | 72 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events24
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 | Application site discharge | General disorders | Placebo | 5 | 80 | |
| other | Application site discharge | General disorders | 0.25% DHEA | 6 | 86 | |
| other | Application site discharge | General disorders | 0.50% DHEA | 5 | 87 | |
| other | Urinary tract infection | Infections and infestations | Placebo | 4 | 80 | |
| other | Urinary tract infection | Infections and infestations | 0.25% DHEA | 6 | 86 | |
| other | Urinary tract infection | Infections and infestations | 0.50% DHEA | 5 | 87 | |
| serious | Gastrointestinal haemorrhage | Gastrointestinal disorders | Placebo | 0 | 80 | |
| serious | Gastrointestinal haemorrhage | Gastrointestinal disorders | 0.25% DHEA | 1 | 86 | |
| serious | Gastrointestinal haemorrhage | Gastrointestinal disorders | 0.50% DHEA | 0 | 87 | |
| serious | Cholecystitis acute | Hepatobiliary disorders | Placebo | 0 | 80 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 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 | 9 | 80 |
| Total, other adverse events | 0.25% DHEA | 12 | 86 |
| Total, other adverse events | 0.50% DHEA | 10 | 87 |
| Total, serious adverse events | Placebo | 0 | 80 |
| Total, serious adverse events | 0.25% DHEA | 3 | 86 |
| Total, serious adverse events | 0.50% DHEA | 1 | 87 |
Source ClinicalTrials.gov
Papers3
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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