Actively Recruiting
Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease
Led by University of Pennsylvania · Updated on 2026-05-13
65
Participants Needed
2
Research Sites
157 weeks
Total Duration
On this page
Sponsors
U
University of Pennsylvania
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Female aged 18 to 50 years old
- Diagnosed with sickle cell disease (SS, SB0, SB+, SC)
- At least 1 vaso-occlusive pain episode per month on average in the last 6 months
- 1 to 10 medical visits for vaso-occlusive pain in the past year, unless approved by the study PI
- Willing to stop any hormonal contraception at enrollment with required washout periods
- Regular menstrual cycles of 21 to 35 days when not on hormonal contraception
- Stable dose of hydroxyurea and other sickle cell medications for 6 months
- Access to a device with text-messaging capability
- Able to read and understand English
- Willing to follow study procedures
You will not qualify if you...
- Chronic inflammatory diseases like lupus or inflammatory bowel disease
- History of blood clots or stroke
- Current use of crizanlizumab, voxelotor, or chronic transfusion therapy
- Current use of hormonal contraception or the copper intrauterine device
- Currently pregnant or pregnant within the last 6 months
- Currently breastfeeding
- Polycystic ovary syndrome or irregular menstrual periods
- High blood pressure (systolic ≥160 or diastolic ≥100) at screening
- Any condition or treatment that risks participant safety, affects results, or prevents full participation as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Emory University
Atlanta, Georgia, United States, 30322
Not Yet Recruiting
2
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
A
Arden McAllister, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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