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

NCT03493126 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2021-12-22

Study results available
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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.

Conditions

  • Vaginal Atrophy

Interventions

DRUG

Estradiol

17β-estradiol vaginal cream

OTHER

Placebo

Compounded placebo cream

Sponsors & Collaborators

  • International Urogynecological Association

    collaborator OTHER

  • Ohio State University

    lead OTHER

Principal Investigators

  • Andrew F Hundley, MD · The Ohio State University, Female Pelvic Medicine and Reconstructive Surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-15
Primary Completion
2020-09-01
Completion
2020-09-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03493126 on ClinicalTrials.gov