At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 59 enrolled
Drug / intervention
Estradiol +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Pilot Randomized Controlled Trial of Vaginal Estrogen on Postpartum Atrophy, Perineal Pain, and Sexual Function
In Brief
A Phase 4 clinical trial evaluating Estradiol and Placebo for Vaginal Atrophy. Completed, enrolled 59 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVaginal Atrophy
CountriesUnited States
CollaboratorsInternational Urogynecological Association
Timeline
Phase 4CompletedFinished
20192020202120222023202420252026
First PostedApr 2018
Enrollment StartOct 2018
Primary CompletionSep 2020
TodayJul 2026
First PostedApr 10, 2018
Enrollment StartOct 15, 2018
Primary CompletionSep 1, 2020
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 8.2 years ago
Interventions
Estradioldrug
17β-estradiol vaginal cream
Placeboother
Compounded placebo cream