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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
University of Pennsylvania
Study ID
NCT06665997
Phase
PHASE4
Status
Recruiting
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Conditions

  • Sickle Cell Disease (SCD)
  • Vaso-Occlusive Pain Episode in Sickle Cell Disease

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Depot medroxyprogesterone acetate (DMPA) — DRUG
    150mg dose intramuscular administration of depot medroxyprogesterone acetate (DMPA) injectable suspension

Study Details

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.

Key Dates

Start date
Jun 26, 2025
Status verified
May 2026
Primary completion
Jul 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
65 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Depot Medroxyprogesterone Acetate (Depo-Provera)
    All participants will receive a 150mg dose intramuscular administration of depot medroxyprogesterone acetate (DMPA) injectable suspension after a 3-month baseline with no hormonal contraception.

Primary Outcome Measure

Frequency of acute vaso-occlusive episodes [ Time Frame: 6 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Emory UniversityAtlantaGeorgia30322
Hailly Butler
[email protected]
404-712-8895
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Kandace Gollomp
[email protected]
215-590-3535

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