Postpartum Vaginal Estrogen for Breastfeeding Patients
United States100 participantsStarted 2025-02-22
Plain-language 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.
Who can participate
Age range18 Years – 50 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18 or older
* 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 (patients may be recruited at any time during the postpartum period, but the study period will not start until 6 weeks postpartum)
* Ability to consent in English
* Not meeting any exclusion criteria
Exclusion Criteria:
* Preterm delivery
* Perinatal mortality
* History of difficulty breastfeeding
* 3rd or 4th degree perineal laceration
* Any contraindications to estrogen, including, but not limited to, breast cancer or a history of breast cancer, estrogen-dependent neoplasia, active deep vein thrombosis (DVT)/pulmonary embolism (PE) or a history of these conditions, active arterial thromboembolic disease (for example, stroke and MI) or a history of these conditions, known anaphylactic reaction, angioedema, or hypersensitivity to estrogen, hepatic impairment or disease, protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders.
What they're measuring
1
Total Female Sexual Function Index (FSFI) score
Timeframe: Up to 12 weeks into study period
Trial details
NCT IDNCT05457972
SponsorUniversity Hospitals Cleveland Medical Center