NCT05457972 Postpartum Vaginal Estrogen for Breastfeeding Patients
| NCT ID | NCT05457972 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University Hospitals Cleveland Medical Center |
| Condition | Breastfeeding |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-02-22 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 100 participants in total. It began in 2025-02-22 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Rachel Pope, MD
PRINCIPAL INVESTIGATOR
University Hospitals Cleveland Medical Center
Frequently Asked Questions
Who can join the NCT05457972 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 50 Years, studying Breastfeeding. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05457972 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05457972 currently recruiting?
Yes, NCT05457972 is actively recruiting participants. Contact the research team at susan.wherley@uhhospitals.org for enrollment information.
Where is the NCT05457972 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT05457972 clinical trial?
NCT05457972 is sponsored by University Hospitals Cleveland Medical Center. The principal investigator is Rachel Pope, MD at University Hospitals Cleveland Medical Center. The trial plans to enroll 100 participants.