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Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease

Study acronym: SCD Depo
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary and study completion pushed from Jul 2028 to Jul 31, 2028v9
  2. Primary and study completion pushed from Oct 2027 to Jul 2028v8
  3. Eligibility criteria expanded, about 60 wordsv7 See this version in full on ClinicalTrials.gov ↗
  4. Eligibility criteria expanded, about 18 wordsv6 See this version in full on ClinicalTrials.gov ↗
  5. Trial status: Not Yet Recruiting to Recruiting Study sites: 3 to 2 · Start date changed from estimate of Jun 2025 to Jun 26, 2025 · Collaborators: 1 to 3v5 Show 3 more changesShow less
    • Study sites: 3 to 2
    • Start date changed from estimate of Jun 2025 to Jun 26, 2025
    • Collaborators: 1 to 3

    See this version in full on ClinicalTrials.gov ↗

Show 3 earlier versionsHide 3 earlier versions
  1. Primary and study completion dates: Apr 2028 to Oct 2027v4
  2. Start date: Apr 2025 to Jun 2025v3
  3. Start date: Dec 2024 to Apr 2025 Study sites revised (3)v2 Show 1 more changeShow less
    • Study sites revised (3)

    See this version in full on ClinicalTrials.gov ↗

  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This research is being conducted to see if using an injectable contraception, Depot Medroxyprogesterone Acetate (Depo-Provera), can reduce the pain experienced by women with sickle cell disease. Participants in this study will be adult women with sickle cell disease who regularly experience sickle cell pain. They will complete a 3-month "baseline "with no use of hormonal contraception, and then a 3-month follow-up after receiving an injection of Depo-Provera. Participants will complete 6 to 7 in-person visits with a urine pregnancy test, blood draw, and surveys, as well as complete remote weekly surveys and monthly home pregnancy tests.
Trial Details
NCT Number NCT06665997
Lead Sponsor University of Pennsylvania
Collaborators: National Heart, Lung, and Blood Institute (NHLBI), Emory University, Children's Hospital of Philadelphia
Conditions Sickle Cell Disease (SCD), Vaso-Occlusive Pain Episode in Sickle Cell Disease
Enrollment 65 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov