NCT03493126

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

A Pilot Randomized Controlled Trial of Vaginal Estrogen on Postpartum Atrophy, Perineal Pain, and Sexual Function

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Ohio State University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

The overall goal of this study is to determine whether there are benefits to use of low-dose vaginal estrogen in the postpartum period. Dyspareunia and vaginal/perineal pain are well-known sequelae after vaginal delivery. However, the contribution of postpartum vaginal atrophy to these issues is largely unknown. Although the relationship between lactation, relative estrogen deprivation, and vulvovaginal atrophy has been established, there is a paucity of data regarding on the prevalence of vulvovaginal atrophy symptoms in the postpartum period. Additionally, although the benefits of vaginal estrogen in postmenopausal atrophy are well-established, the benefits in the postpartum period are unknown.

Conditions

• Vaginal Atrophy

Interventions

Type	Name	Description
DRUG	Estradiol	17β-estradiol vaginal cream
OTHER	Placebo	Compounded placebo cream

Timeline

• Start date: 2018-10-15
• Primary completion: 2020-09-01
• Completion: 2020-09-01
• First posted: 2018-04-10
• Last updated: 2021-12-22
• Results posted: 2021-12-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study