Trial · NCT01846442
Topical DHEA Against Vaginal Atrophy
NCT01846442, Phase 3, Completed, EndoCeutics Inc.; results first posted 2017-04-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Topical DHEA Against Vaginal Atrophy. Trials, record NCT01846442. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01846442
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Topical DHEA Against Vaginal Atrophy
- NCT number
- NCT01846442
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 218 participants, actual
- Lead sponsor
- EndoCeutics Inc.
- Conditions
- Vaginal Atrophy
- Interventions
- Placebo, DHEA (0.25%), DHEA (0.5%), DHEA (1.0%)
- First posted
- 2013-05-03
- Last updated
- 2017-08-29
- Results first posted
- 2017-04-28
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Parabasal Cells) | 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 | Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Superficial Cells) | 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 | Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal pH. | Baseline and Week 12 | 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. |
| Primary | Co-primary Endpoint: Change From Baseline to Week 12 of Self-assessment of the Most Bothersome Symptom Dyspareunia | Baseline and Week 12 | 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. |
| Secondary | Change From Baseline to Week 12 of Vaginal Secretions | Baseline and Week 12 | 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. |
| Secondary | Change From Baseline to Week 12 of Vaginal Epithelial Integrity | Baseline and Week 12 | 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. |
| Secondary | Change From Baseline to Week 12 of Vaginal Epithelial Surface Thickness | Baseline and Week 12 | 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. |
| Secondary | Change From Baseline to Week 12 of Vaginal Color | Baseline and Week 12 | 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. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Parabasal Cells) | Baseline and Week 12 | 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. | percentage of parabasal cells | MEAN |
| PRIMARY | Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Superficial Cells) | Baseline and Week 12 | 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. | percentage of superficial cells | MEAN |
| PRIMARY | Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal pH. | Baseline and Week 12 | 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. | pH | MEAN |
| PRIMARY | Co-primary Endpoint: Change From Baseline to Week 12 of Self-assessment of the Most Bothersome Symptom Dyspareunia | Baseline and Week 12 | 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. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to Week 12 of Vaginal Secretions | Baseline and Week 12 | 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. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to Week 12 of Vaginal Epithelial Integrity | Baseline and Week 12 | 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. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to Week 12 of Vaginal Epithelial Surface Thickness | Baseline and Week 12 | 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. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to Week 12 of Vaginal Color | Baseline and Week 12 | 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. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group96
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Parabasal Cells) | Placebo | Baseline | 46.7 | Standard Error 8.64 | percentage of parabasal cells |
| Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Parabasal Cells) | 0.25% DHEA | Baseline | 65.5 | Standard Error 6.92 | percentage of parabasal cells |
| Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Parabasal Cells) | 0.50% DHEA | Baseline | 53.4 | Standard Error 7.49 | percentage of parabasal cells |
| Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Parabasal Cells) | 1.00% DHEA | Baseline | 61.8 | Standard Error 6.88 | percentage of parabasal cells |
| Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Parabasal Cells) | Placebo | Week 12 | 47.8 | Standard Error 7.52 | percentage of parabasal cells |
| Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Parabasal Cells) | 0.25% DHEA | Week 12 | 16.9 | Standard Error 3.66 | percentage of parabasal cells |
| Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Parabasal Cells) | 0.50% DHEA | Week 12 | 11.0 | Standard Error 3.43 | percentage of parabasal cells |
| Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Parabasal Cells) | 1.00% DHEA | Week 12 | 6.90 | Standard Error 1.77 | percentage of parabasal cells |
| Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Parabasal Cells) | Placebo | Change from Baseline | 1.1 | Standard Error 3.62 | percentage of parabasal cells |
| Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Parabasal Cells) | 0.25% DHEA | Change from Baseline | -48.6 | Standard Error 6.78 | percentage of parabasal cells |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 54 | |
| Overall Study | STARTED | 0.25% DHEA | 54 | |
| Overall Study | STARTED | 0.50% DHEA | 56 | |
| Overall Study | STARTED | 1.00% DHEA | 54 | |
| Overall Study | Safety Population | Placebo | 54 | |
| Overall Study | Safety Population | 0.25% DHEA | 53 | |
| Overall Study | Safety Population | 0.50% DHEA | 56 | |
| Overall Study | Safety Population | 1.00% DHEA | 54 | |
| Overall Study | ITT Population | Placebo | 53 | |
| Overall Study | ITT Population | 0.25% DHEA | 53 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events48
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 | Abdominal pain | Gastrointestinal disorders | Placebo | 4 | 54 | |
| other | Abdominal pain | Gastrointestinal disorders | 0.25% DHEA | 2 | 53 | |
| other | Abdominal pain | Gastrointestinal disorders | 0.50% DHEA | 3 | 56 | |
| other | Abdominal pain | Gastrointestinal disorders | 1.00% DHEA | 5 | 54 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Placebo | 5 | 54 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | 0.25% DHEA | 2 | 53 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | 0.50% DHEA | 4 | 56 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | 1.00% DHEA | 5 | 54 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Placebo | 2 | 54 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | 0.25% DHEA | 2 | 53 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 adverse eventsAdverse event totals12
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, all-cause mortality | 1.00% DHEA | ||
| Total, other adverse events | Placebo | 34 | 54 |
| Total, other adverse events | 0.25% DHEA | 32 | 53 |
| Total, other adverse events | 0.50% DHEA | 46 | 56 |
| Total, other adverse events | 1.00% DHEA | 39 | 54 |
| Total, serious adverse events | Placebo | 0 | 54 |
| Total, serious adverse events | 0.25% DHEA | 1 | 53 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers9
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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