Trial · NCT03493126
Vaginal Estrogen on Postpartum Atrophy, Perineal Pain, and Sexual Function
NCT03493126, Phase 4, Completed, Ohio State University; results first posted 2021-12-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Vaginal Estrogen on Postpartum Atrophy, Perineal Pain, and Sexual Function. Trials, record NCT03493126. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03493126
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Vaginal Estrogen on Postpartum Atrophy, Perineal Pain, and Sexual Function
- NCT number
- NCT03493126
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 59 participants, actual
- Lead sponsor
- Ohio State University
- Conditions
- Vaginal Atrophy
- Interventions
- Estradiol, Placebo
- First posted
- 2018-04-10
- Last updated
- 2021-12-22
- Results first posted
- 2021-12-22
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Vulvar Assessment Scale (VUAS) | 3 months | The VUAS is a four-item measurement administered by a clinical provider that quantifies and rates the patient's responses to questions of dryness, soreness, irritation and pain to external stimulation. Patients are asked whether they have experienced specific symptoms ("yes/no") during the past 4 weeks and rate symptom severity ("none," "mild," "moderate," "severe"). The first 3 items assess dryness, soreness, and irritation during routine activities excluding sexual intercourse and the fourth item assesses pain with external manual stimulation. An option for "no attempt" indicates a patient has not been sexually active within the past 4 weeks. Each item in the VuAS is scored from 0 (none) to 3 (severe) with composite scores calculated by taking the mean of the items when at least two of four items are not missing. Higher scores indicate worse symptoms. The minimum composite score is 0 and maximum composite score is 3. |
| Secondary | Depression | 3 months | Edinburgh Postnatal Depression Scale (EPDS) The EPDS is a validated 10-question depression assessment for postpartum women, which includes anxiety symptoms and excludes constitutional symptoms associated with depression common in the postpartum period, such as changes in sleeping patterns. Questions 1, 2, \& 4 are scored 0, 1, 2 or 3 with top box scored as 0 and the bottom box scored as 3. Questions 3 and 5--10 are reverse scored, with the top box scored as a 3 and the bottom box scored as 0. Minimum total score: 0 Maximum total score: 30. Total score of 10 or higher may be indicative of postpartum depression. |
| Secondary | Urinary Symptoms | 3 months | Urinary Distress Inventory (UDI-6) The UDI-6 is a questionnaire that includes 6 items evaluating bother from urinary symptoms with higher scores indicating more disability. Each item is scored from 0-3. The total score is the average individual score multiplied by 25. The minimal score is 0 and maximum score is 100. |
| Secondary | Fecal Incontinence | 3 months | Fecal Incontinence Severity Index (FISI) for bowel symptoms The FISI evaluates patient responses symptom severity to fecal incontinence with higher scores indicating more bothersome anal incontinence symptoms. The FISI score ranges from 0 to 61 with higher score indicating higher severity of the fecal incontinence. |
| Secondary | Sexual Function | 3 months | Female Sexual Function Index (FSFI) The FSFI is a validated questionnaire to assess sexual function in six domains of sexual function, including desire, arousal, lubrication, orgasm, satisfaction, and pain over the 4 weeks prior to administration of questionnaire with lower scores indicating more sexual dysfunction. The FSFI score ranges from 2-36 with LOWER score indicating worse sexual dysfunction. |
| Secondary | Satisfaction Via Likert Scale | 3 months | Likert scale Satisfaction will be assessed using the patient satisfaction questionnaire in response to the question, "How satisfied were you with your progress with this treatment?" |
| Secondary | Adverse Outcomes | 3 months | At each clinical/research visit the participant will be asked about any adverse events (AEs). AEs will be reported with study outcomes. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Vulvar Assessment Scale (VUAS) | 3 months | score on a scale | MEAN | |
| SECONDARY | Depression | 3 months | score on a scale | MEAN | |
| SECONDARY | Urinary Symptoms | 3 months | score on a scale | MEAN | |
| SECONDARY | Fecal Incontinence | 3 months | score on a scale | MEAN | |
| SECONDARY | Sexual Function | 3 months | score on a scale | MEAN | |
| SECONDARY | Satisfaction Via Likert Scale | 3 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Adverse Outcomes | 3 months | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Vulvar Assessment Scale (VUAS) | Estradiol | 0.10 | Standard Deviation 0.25 | score on a scale | |
| Vulvar Assessment Scale (VUAS) | Placebo | 0.20 | Standard Deviation 0.22 | score on a scale | |
| Depression | Estradiol | 4.07 | Standard Deviation 3.71 | score on a scale | |
| Depression | Placebo | 4.07 | Standard Deviation 2.99 | score on a scale | |
| Urinary Symptoms | Estradiol | 5.6 | Standard Deviation 10.2 | score on a scale | |
| Urinary Symptoms | Placebo | 10.5 | Standard Deviation 23.5 | score on a scale | |
| Fecal Incontinence | Estradiol | 16.5 | Standard Deviation 14.3 | score on a scale | |
| Fecal Incontinence | Placebo | 15.4 | Standard Deviation 12.4 | score on a scale | |
| Sexual Function | Estradiol | 25.4 | Standard Deviation 8.1 | score on a scale | |
| Sexual Function | Placebo | 20.5 | Standard Deviation 10.8 | score on a scale |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Estradiol | 31 | |
| Overall Study | STARTED | Placebo | 28 | |
| Overall Study | COMPLETED | Estradiol | 28 | |
| Overall Study | COMPLETED | Placebo | 28 | |
| Overall Study | NOT COMPLETED | Estradiol | 3 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Estradiol | 0 | 31 |
| Total, all-cause mortality | Placebo | 0 | 28 |
| Total, other adverse events | Estradiol | 0 | 31 |
| Total, other adverse events | Placebo | 0 | 28 |
| Total, serious adverse events | Estradiol | 0 | 31 |
| Total, serious adverse events | Placebo | 0 | 28 |
Source ClinicalTrials.gov
Papers5
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Estradiol vs Placebo: Adverse Outcomes | Trial comparisons |
| Estradiol vs Placebo: deaths from any cause | Trial comparisons |
| Estradiol vs Placebo: serious adverse events | Trial comparisons |
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/NCT03493126
GET https://conductscience.org/api/trials/v1/NCT03493126/registered