Actively Recruiting

Phase 4
Age: 18Years - 50Years
FEMALE
ID05457972

Postpartum Vaginal Estrogen for Sexual Function in Breastfeeding Patients: A Randomized Controlled Trial

Led by University Hospitals Cleveland Medical Center · Updated on 2026-03-10

100

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying sexual dysfunction in breastfeeding postpartum patients to see if using vaginal estrogen cream improves sexual function compared to not using it. This randomized clinical trial focuses on patients who have recently given birth and are breastfeeding or pumping, aiming to better understand treatment options during the postpartum period. Participants will be randomly assigned to one of two groups: one group will use estradiol vaginal inserts, and the other will use a vaginal moisturizer. Both treatments start after 6 weeks postpartum, with daily use for two weeks followed by twice-weekly use for ten weeks. Study supplies will be delivered to participants' homes, and instructions on usage will be provided. The study period lasts 12 weeks, with follow-up questionnaires at 6 weeks, 12 weeks, 6 months, and 1 year to assess long-term effects. Participants will complete questionnaires about sexual function, anxiety, depression, urinary symptoms, and vaginal health using secure online tools. Weekly messages will check breastfeeding status, sexual activity, vaginal pain, treatment use, and health changes. Safety monitoring will be conducted, and those showing signs of depression or anxiety will be referred for further care. The study measures sexual function scores up to 12 weeks and tracks participant wellbeing over one year.

CONDITIONS

Brief Title

Postpartum Vaginal Estrogen for Breastfeeding Patients

Who Can Participate

Age: 18Years - 50Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 or older
  • Female sex
  • Sexually active
  • Singleton, term (37 weeks 0 days) birth
  • Planning to breastfeed or pump during the study period
  • History of successful breastfeeding or pumping after a prior pregnancy
  • Between 6 weeks and 6 months postpartum
  • Ability to consent in English
  • Not meeting any exclusion criteria
Not Eligible

You will not qualify if you...

  • Preterm delivery
  • Perinatal mortality
  • History of difficulty breastfeeding
  • 3rd or 4th degree perineal laceration
  • Any contraindications to estrogen, including breast cancer or history of breast cancer
  • Estrogen-dependent neoplasia
  • Active or history of deep vein thrombosis (DVT) or pulmonary embolism (PE)
  • Active or history of arterial thromboembolic disease such as stroke or myocardial infarction (MI)
  • Known anaphylactic reaction, angioedema, or hypersensitivity to estrogen
  • Hepatic impairment or disease
  • Protein C, protein S, or antithrombin deficiency
  • Other known thrombophilic disorders

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - Up to hospital discharge after delivery

Participants are screened for eligibility to participate in the trial.

1 visit (in-person at hospital before discharge)

Enrollment and Baseline Assessment

Duration - Between 5 and 6 weeks postpartum

Participants provide informed consent and complete a baseline questionnaire about demographics, prior deliveries, and baseline sexual activity.

1 baseline contact (remote via text or email)

Treatment

Duration - 12 weeks

Participants use either vaginal estrogen inserts or vaginal moisturizer nightly for two weeks, then twice weekly for ten weeks. Weekly messaging collects information on breastfeeding, sexual activity, vaginal pain, product use, and health changes.

Weekly remote contacts with messages and questionnaires; 2 remote questionnaires at Weeks 6 and 12

Follow-up

Duration - Up to 1 year after treatment

Participants complete additional questionnaires at 6 months and 1 year to assess longer-term outcomes after stopping study treatment.

2 remote questionnaire contacts

Trial Site Locations

Total: 1 location

1

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States, 44106

Actively Recruiting

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Research Team

S

Susan D Wherley, MD

R

Rosemary Brewka

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

The REJOICE trial: a phase 3 randomized, controlled trial evaluating the safety and efficacy of a novel vaginal estradiol soft-gel capsule for symptomatic vulvar and vaginal atrophy.

Ginger D Constantine, James A Simon, James H Pickar...

https://pubmed.ncbi.nlm.nih.gov/27922936

The risks and rewards of covariate adjustment in randomized trials: an assessment of 12 outcomes from 8 studies.

Brennan C Kahan, Vipul Jairath, Caroline J Doré...

https://pubmed.ncbi.nlm.nih.gov/24755011

Incidence and Prevalence of Sexual Dysfunction in Women and Men: A Consensus Statement from the Fourth International Consultation on Sexual Medicine 2015.

Marita P McCabe, Ira D Sharlip, Ron Lewis...

https://pubmed.ncbi.nlm.nih.gov/26953829

Genitourinary syndrome of menopause: new terminology for vulvovaginal atrophy from the International Society for the Study of Women's Sexual Health and the North American Menopause Society.

David J Portman, Margery L S Gass, Vulvovaginal Atrophy Terminology Consensus Conference Panel

https://pubmed.ncbi.nlm.nih.gov/25160739