RecruitingPhase 4NCT05457972

Postpartum Vaginal Estrogen for Breastfeeding Patients

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


Sponsor

University Hospitals Cleveland Medical Center

Enrollment

100 participants

Start Date

Feb 22, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Sexual dysfunction is very common in the postpartum period and is more common in people who breastfeed or pump. This research study was designed to help determine whether postpartum patients who use vaginal estrogen cream while breastfeeding have improved sexual function compared to postpartum patients who do not.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether using a low-dose vaginal estrogen cream after childbirth can help breastfeeding mothers maintain their milk supply and improve vaginal health. Low estrogen during breastfeeding can cause vaginal dryness and discomfort, and there are concerns estrogen may reduce milk production — this study aims to find out. You may be eligible if: - You are 18 or older - You gave birth to a single baby at or after 37 weeks of pregnancy - You are planning to breastfeed or pump during the study - You successfully breastfed or pumped after a previous pregnancy - You are between 6 weeks and 6 months postpartum - You are sexually active - You can consent in English You may NOT be eligible if: - You delivered preterm (before 37 weeks) - You have had difficulty breastfeeding in the past - You experienced a severe perineal tear (3rd or 4th degree) - You have any contraindication to estrogen: history of breast cancer, blood clots (DVT/PE), stroke or heart attack, liver disease, protein C/S or antithrombin deficiency, or known thrombophilia Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEstradiol

Imvexxy is an FDA-approved drug produced by TherapeuticsMD.

DEVICEVaginal Moisturizer

Ingredients include hydrogenated coconut and palm oils and natural-source vitamin E (d-alpha tocopheryl acetate and tocopherols).


Locations(1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

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NCT05457972


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