Trial · NCT02253173
Estradiol Vaginal Softgel Capsules in Treating Symptoms of Vulvar and Vaginal Atrophy in Postmenopausal Women
NCT02253173, Phase 3, Completed, TherapeuticsMD; results first posted 2017-05-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Estradiol Vaginal Softgel Capsules in Treating Symptoms of Vulvar and Vaginal Atrophy in Postmenopausal Women. Trials, record NCT02253173. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02253173
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Estradiol Vaginal Softgel Capsules in Treating Symptoms of Vulvar and Vaginal Atrophy in Postmenopausal Women
- NCT number
- NCT02253173
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 764 participants, actual
- Lead sponsor
- TherapeuticsMD
- Conditions
- Vulvovaginal Atrophy, Menopause, Dyspareunia, Painful Intercourse
- Interventions
- Estradiol, Placebo
- First posted
- 2014-10-01
- Last updated
- 2017-05-25
- Results first posted
- 2017-05-25
Source ClinicalTrials.gov
Registered outcomes48
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Co-Primary Efficacy Endpoint - Vaginal Superficial Cells | Baseline and 12 Weeks | • Change from Baseline to Week 12 in the percentage of vaginal superficial cells (by vaginal cytologic smear) compared to placebo |
| Primary | Co-Primary Efficacy Endpoint - Vaginal Parabasal Cells | Baseline and 12 Weeks | • Change from Baseline to Week 12 in the percentage of vaginal parabasal cells (by vaginal cytologic smear) compared to placebo |
| Primary | Co-Primary Efficacy Endpoint - Vaginal pH | Baseline and 12 Weeks | • Change from Baseline to Week 12 in vaginal pH as compared to placebo |
| Primary | Co-Primary Efficacy Endpoint - Severity of Most Bothersome Symptom (Dyspareunia) | Baseline and Week 12 | • Change from Baseline to Week 12 on the severity of the MBS of dyspareunia (vaginal pain associated with sexual activity) associated with VVA as compared to placebo VVA Symptoms Self-Assessment Questionnaire Severity Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe. Subjects assessed severity at Baseline and Week 12 |
| Secondary | Secondary Efficacy Endpoints - Vaginal Superficial Cells | Baseline and Week 2 | • Change from Baseline to Week 2 in the percentage of vaginal superficial cells (by vaginal cytologic smear) compared to placebo |
| Secondary | Secondary Efficacy Endpoints- Vaginal Superficial Cells | Baseline and Week 6 | Change from Baseline to Week 6 in the percentage of vaginal superficial cells (by vaginal cytologic smear) compared to placebo |
| Secondary | Secondary Efficacy Endpoints - Vaginal Superficial Cells | Baseline and Week 8 | Change from Baseline to Week 8 in the percentage of vaginal superficial cells (by vaginal cytologic smear) compared to placebo |
| Secondary | Secondary Efficacy Endpoints - Vaginal Parabasal Cells | Baseline and Week 2 | Change from Baseline to Week 2 in the percentage of vaginal parabasal cells (by vaginal cytologic smear) compared to placebo |
| Secondary | Secondary Efficacy Endpoints - Vaginal Parabasal Cells | Baseline and Week 6 | Change from Baseline to Week 6 in the percentage of vaginal parabasal cells (by vaginal cytologic smear) compared to placebo |
| Secondary | Secondary Efficacy Endpoints - Vaginal Parabasal Cells | Baseline and Week 8 | Change from Baseline to Week 8 in the percentage of vaginal parabasal cells (by vaginal cytologic smear) compared to placebo |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 registered outcomesOutcomes48
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Co-Primary Efficacy Endpoint - Vaginal Superficial Cells | Baseline and 12 Weeks | For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 12 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline. | percentage of vaginal superficial cells | LEAST_SQUARES_MEAN |
| PRIMARY | Co-Primary Efficacy Endpoint - Vaginal Parabasal Cells | Baseline and 12 Weeks | For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 12 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline. | percentage of vaginal parabasal cells | LEAST_SQUARES_MEAN |
| PRIMARY | Co-Primary Efficacy Endpoint - Vaginal pH | Baseline and 12 Weeks | For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 12 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline. | pH units | LEAST_SQUARES_MEAN |
| PRIMARY | Co-Primary Efficacy Endpoint - Severity of Most Bothersome Symptom (Dyspareunia) | Baseline and Week 12 | For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 12 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Secondary Efficacy Endpoints - Vaginal Superficial Cells | Baseline and Week 2 | For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 2 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline. | percentage of vaginal superficial cells | LEAST_SQUARES_MEAN |
| SECONDARY | Secondary Efficacy Endpoints- Vaginal Superficial Cells | Baseline and Week 6 | For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 6 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline. | percentage of vaginal superficial cells | LEAST_SQUARES_MEAN |
| SECONDARY | Secondary Efficacy Endpoints - Vaginal Superficial Cells | Baseline and Week 8 | For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 8 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline. | percentage of vaginal superficial cells | LEAST_SQUARES_MEAN |
| SECONDARY | Secondary Efficacy Endpoints - Vaginal Parabasal Cells | Baseline and Week 2 | For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 2 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline. | percentage of vaginal parabasal cells | LEAST_SQUARES_MEAN |
| SECONDARY | Secondary Efficacy Endpoints - Vaginal Parabasal Cells | Baseline and Week 6 | For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 6 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline. | percentage of vaginal parabasal cells | LEAST_SQUARES_MEAN |
| SECONDARY | Secondary Efficacy Endpoints - Vaginal Parabasal Cells | Baseline and Week 8 | For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 8 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline. | percentage of vaginal parabasal cells | LEAST_SQUARES_MEAN |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 outcomesResults by group188
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Co-Primary Efficacy Endpoint - Vaginal Superficial Cells | Estradiol 4mcg Vaginal Softgel Capsule | 17.50 | Standard Error 1.542 | percentage of vaginal superficial cells | |
| Co-Primary Efficacy Endpoint - Vaginal Superficial Cells | Estradiol 10mcg Vaginal Softgel Capsule | 16.72 | Standard Error 1.540 | percentage of vaginal superficial cells | |
| Co-Primary Efficacy Endpoint - Vaginal Superficial Cells | Estradiol 25mcg Vaginal Softgel Capsule | 23.20 | Standard Error 1.529 | percentage of vaginal superficial cells | |
| Co-Primary Efficacy Endpoint - Vaginal Superficial Cells | Placebo | 5.63 | Standard Error 1.537 | percentage of vaginal superficial cells | |
| Co-Primary Efficacy Endpoint - Vaginal Parabasal Cells | Estradiol 4mcg Vaginal Softgel Capsule | -40.63 | Standard Error 1.755 | percentage of vaginal parabasal cells | |
| Co-Primary Efficacy Endpoint - Vaginal Parabasal Cells | Estradiol 10mcg Vaginal Softgel Capsule | -44.07 | Standard Error 1.751 | percentage of vaginal parabasal cells | |
| Co-Primary Efficacy Endpoint - Vaginal Parabasal Cells | Estradiol 25mcg Vaginal Softgel Capsule | -45.55 | Standard Error 1.745 | percentage of vaginal parabasal cells | |
| Co-Primary Efficacy Endpoint - Vaginal Parabasal Cells | Placebo | -6.73 | Standard Error 1.750 | percentage of vaginal parabasal cells | |
| Co-Primary Efficacy Endpoint - Vaginal pH | Estradiol 4mcg Vaginal Softgel Capsule | -1.32 | Standard Error 0.066 | pH units | |
| Co-Primary Efficacy Endpoint - Vaginal pH | Estradiol 10mcg Vaginal Softgel Capsule | -1.42 | Standard Error 0.066 | pH units |
1 to 10 of 188Source ClinicalTrials.gov
See all 188 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Estradiol 4mcg Vaginal Softgel Capsule | 191 | |
| Overall Study | STARTED | Estradiol 10mcg Vaginal Softgel Capsule | 191 | |
| Overall Study | STARTED | Estradiol 25mcg Vaginal Softgel Capsule | 190 | |
| Overall Study | STARTED | Placebo Vaginal Softgel Capsule | 192 | |
| Overall Study | COMPLETED | Estradiol 4mcg Vaginal Softgel Capsule | 175 | |
| Overall Study | COMPLETED | Estradiol 10mcg Vaginal Softgel Capsule | 174 | |
| Overall Study | COMPLETED | Estradiol 25mcg Vaginal Softgel Capsule | 177 | |
| Overall Study | COMPLETED | Placebo Vaginal Softgel Capsule | 178 | |
| Overall Study | NOT COMPLETED | Estradiol 4mcg Vaginal Softgel Capsule | 16 | |
| Overall Study | NOT COMPLETED | Estradiol 10mcg Vaginal Softgel Capsule | 17 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events68
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 | Estradiol 4mcg Vaginal Softgel Capsule | 5 | 191 | |
| other | Nasopharyngitis | Infections and infestations | Estradiol 10mcg Vaginal Softgel Capsule | 6 | 191 | |
| other | Nasopharyngitis | Infections and infestations | Estradiol 25mcg Vaginal Softgel Capsule | 7 | 190 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 10 | 192 | |
| other | Upper respiratory infection | Infections and infestations | Estradiol 4mcg Vaginal Softgel Capsule | 5 | 191 | |
| other | Upper respiratory infection | Infections and infestations | Estradiol 10mcg Vaginal Softgel Capsule | 6 | 191 | |
| other | Upper respiratory infection | Infections and infestations | Estradiol 25mcg Vaginal Softgel Capsule | 3 | 190 | |
| other | Upper respiratory infection | Infections and infestations | Placebo | 5 | 192 | |
| other | Urinary tract infection | Infections and infestations | Estradiol 4mcg Vaginal Softgel Capsule | 5 | 191 | |
| other | Urinary tract infection | Infections and infestations | Estradiol 10mcg Vaginal Softgel Capsule | 5 | 191 |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Estradiol 4mcg Vaginal Softgel Capsule | ||
| Total, all-cause mortality | Estradiol 10mcg Vaginal Softgel Capsule | ||
| Total, all-cause mortality | Estradiol 25mcg Vaginal Softgel Capsule | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Estradiol 4mcg Vaginal Softgel Capsule | 46 | 191 |
| Total, other adverse events | Estradiol 10mcg Vaginal Softgel Capsule | 41 | 191 |
| Total, other adverse events | Estradiol 25mcg Vaginal Softgel Capsule | 45 | 190 |
| Total, other adverse events | Placebo | 66 | 192 |
| Total, serious adverse events | Estradiol 4mcg Vaginal Softgel Capsule | 0 | 191 |
| Total, serious adverse events | Estradiol 10mcg Vaginal Softgel Capsule | 3 | 191 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers5
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.
GET https://conductscience.org/api/trials/v1/NCT02253173
GET https://conductscience.org/api/trials/v1/NCT02253173/registered?page=2