Postpartum Vaginal Estrogen for Breastfeeding Patients
Postpartum Vaginal Estrogen for Sexual Function in Breastfeeding Patients: A Randomized Controlled Trial
University Hospitals Cleveland Medical Center
100 participants
Feb 22, 2025
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
Inclusion Criteria7
- 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
Exclusion Criteria5
- Preterm delivery
- Perinatal mortality
- History of difficulty breastfeeding
- rd 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.
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Interventions
Imvexxy is an FDA-approved drug produced by TherapeuticsMD.
Ingredients include hydrogenated coconut and palm oils and natural-source vitamin E (d-alpha tocopheryl acetate and tocopherols).
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05457972