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Postpartum Vaginal Estrogen for Breastfeeding Patients

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Sep 30, 2026 → Dec 31, 2026
See other at-risk trials from University Hospitals Cleveland Medical Center

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Sep 30, 2026 to Dec 31, 2026
    • Secondary endpoints: 7 to 9
    v12
  2. Primary and study completion dates: Mar 30, 2026 to Sep 30, 2026v11
  3. Primary and study completion dates: Oct 2025 to Mar 30, 2026v10
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 31, 2025 to Feb 22, 2025
    • Site details revised
    v9
  5. Start date: Nov 1, 2024 to Jan 31, 2025
    • Primary and study completion dates: Aug 2025 to Oct 2025
    v8
Show 6 earlier versionsHide 6 earlier versions
  1. Start date: Jul 1, 2024 to Nov 1, 2024
    • Primary and study completion dates: Apr 2025 to Aug 2025
    v7
  2. Start date: Jan 1, 2024 to Jul 1, 2024
    • Primary and study completion dates: Oct 2024 to Apr 2025
    v6
  3. Start date: Sep 1, 2023 to Jan 1, 2024
    • Primary and study completion dates: Jun 2024 to Oct 2024
    v5
  4. Start date: Jun 1, 2023 to Sep 1, 2023v4
  5. Start date: Jan 22, 2023 to Jun 1, 2023v3
  6. Primary and study completion dates: Aug 2023 to Jun 2024v2 Show 6 more changesShow less
    • Start date: Aug 2022 to Jan 22, 2023
    • Primary endpoint revised
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints revised (7)
    • Study description expanded, about 34 words
    • Study title expanded, about 3 words
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05457972
Lead Sponsor University Hospitals Cleveland Medical Center
Conditions
(from sponsor)		 Breastfeeding, Postpartum Sexual Dysfunction, Vaginal Atrophy
Related terms Breast Feeding, Dyspareunia, Sexual Dysfunction, Physiological
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov