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NCT05457972 · ClinicalTrials.gov registry record · Phase 4
Postpartum Vaginal Estrogen for Breastfeeding Patients
A Phase 4 study of Breastfeeding and Vaginal Atrophy, sponsored by University Hospitals Cleveland Medical Center.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT05457972: Recruiting Phase 4 study of Breastfeeding and Vaginal Atrophy, sponsored by University Hospitals Cleveland Medical Center.
NCT05457972 is a Phase 4 study of Breastfeeding and Vaginal Atrophy that is actively recruiting participants, run by University Hospitals Cleveland Medical Center. The registered enrollment target is 100 participants, below the 594-participant average among 36 other Breastfeeding trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05457972, a Phase 4 study of Breastfeeding and Vaginal Atrophy, is actively recruiting participants, sponsored by University Hospitals Cleveland Medical Center.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Female Sexual Function Index (FSFI) overall score has six domains and a maximum score of 36, with a higher score indicating better functioning. A score of 26 has been validated as a threshold for diagnosing female sexual dysfunction.
Conditions Studied
Interventions
- DRUG Estradiol
- DEVICE Vaginal Moisturizer
Study Locations (1)
Ohio
- University Hospitals Cleveland Medical Center - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2025-02-22 |
| Est. Completion | 2026-09-30 |
| Phase | Phase 4 |
What NCT05457972 shows while recruiting
NCT05457972 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 594-participant average among 36 other Breastfeeding trials with a reported enrollment target (83% lower).
The record links to 3 conditions, with Breastfeeding appearing as the primary indexed condition, and to 2 interventions - of which Estradiol is the first listed.
NCT05457972 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT05457972 about?
NCT05457972 is a clinical study titled "Postpartum Vaginal Estrogen for Breastfeeding Patients". 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 patie...
What is the current status of trial NCT05457972?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 100 participants. The study started on 2025-02-22. Estimated completion is 2026-09-30.
What conditions does trial NCT05457972 study?
This clinical trial studies the following conditions: Breastfeeding, Vaginal Atrophy, Postpartum Sexual Dysfunction.
What interventions are being tested in trial NCT05457972?
The interventions under investigation include: Estradiol (DRUG), Vaginal Moisturizer (DEVICE).
Who is sponsoring clinical trial NCT05457972?
This trial is sponsored by University Hospitals Cleveland Medical Center, which has 230 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05457972 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breastfeeding
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05457972's enrollment target sits among peer trials
100 23rd of 36 higher than 14 of 36 other Breastfeeding trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breastfeeding trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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