Depo-Provera for Sickle Cell Anemia
(SCD Depo Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byAndrea Roe, MD MPH

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: University of Pennsylvania

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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 Criteria

Adult women with sickle cell disease who often have pain from their condition can join this study. They must not be using hormonal contraception during the initial 3-month baseline period and should be willing to receive Depo-Provera injections and complete various tests and surveys.

Inclusion Criteria

I agree to stop using hormonal birth control and have followed the required waiting period.

Must be able to read and understand English

I've had 1 to 10 hospital visits for sickle cell pain in the last year.

+7 more

Exclusion Criteria

Current pregnancy or pregnancy within the last 6 months

Current lactation

I am currently using hormonal birth control or a copper IUD.

+5 more

Participant Groups

The trial is testing if Depot Medroxyprogesterone Acetate (Depo-Provera), an injectable contraceptive, can lessen pain in women with sickle cell disease. It involves a comparison between a 3-month period without hormonal contraception and a subsequent 3-month period after receiving the injection.

1Treatment groups

Experimental Treatment

Group I: Depot Medroxyprogesterone Acetate (Depo-Provera)Experimental Treatment1 Intervention

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.