Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease
University of Pennsylvania
Summary
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.
Eligibility
- Age range
- 18–50 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Female, aged 18-50 years old 3. Diagnosis of sickle cell disease (SS, SB0,SB+,SC) 4. Report of at least 1 vaso-occlusive pain episode per month on average in the previous 6 months 5. At least 1 and no more than 10 medical presentations (e.g. hospitalization, emergencyroom visit, outpatient infusion visit) for vaso-occlusive pain during the past year, unless approved by study PI Andrea Roe 6. Willing to discontinue any hormonal contraception at the time of enrollment. Washout period of 1 month since last use of all h…
Interventions
- DrugDepot medroxyprogesterone acetate (DMPA)
150mg dose intramuscular administration of depot medroxyprogesterone acetate (DMPA) injectable suspension
Locations (2)
- Emory UniversityAtlanta, Georgia
- Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania