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NCT03493126 · ClinicalTrials.gov registry record · Phase 4

Vaginal Estrogen on Postpartum Atrophy, Perineal Pain, and Sexual Function

A Phase 4 study, sponsored by Ohio State University.

Completed
Registry status
Phase 4
Development phase
59
Enrollment target

NCT03493126: Completed Phase 4 study, sponsored by Ohio State University.

NCT03493126 is a Phase 4 study that has completed, run by Ohio State University. The registered enrollment target is 59 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03493126, a Phase 4 study, has completed, sponsored by Ohio State University.

COMPLETED
Registry status
Phase 4
Development phase
59 participants
Enrollment target

Study Summary

Pilot randomized, placebo-controlled trial of nulliparous postpartum women with a perineal laceration following a term vaginal delivery comparing vulvovaginal atrophy symptoms between women using vaginal estrogen in the postpartum period with those using placebo.

Primary Outcome

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 i

Interventions

  • OTHER Placebo
  • DRUG Estradiol

Trial Details

FieldValue
Enrollment Target 59 participants
Start Date 2018-10-15
Est. Completion 2020-09-01
Phase Phase 4
Ohio State University

552 total trials

What the finished NCT03493126 record still lists

NCT03493126 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT03493126 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03493126 about?

NCT03493126 is a clinical study titled "Vaginal Estrogen on Postpartum Atrophy, Perineal Pain, and Sexual Function". Pilot randomized, placebo-controlled trial of nulliparous postpartum women with a perineal laceration following a term vaginal delivery comparing vulvovaginal atrophy symptoms between women using vaginal estrogen in the postpartum period with those using placebo.

What is the current status of trial NCT03493126?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 59 participants. The study started on 2018-10-15. Estimated completion is 2020-09-01.

What interventions are being tested in trial NCT03493126?

The interventions under investigation include: Placebo (OTHER), Estradiol (DRUG).

Who is sponsoring clinical trial NCT03493126?

This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03493126's enrollment target sits among peer trials

59 1202nd of 2000 higher than 796 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03493126, the US trial registry maintained by the National Library of Medicine. NCT03493126 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.