NCT06665997RecruitingPhase 4
Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease
Source: ClinicalTrials.gov · Last updated 28 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 65 (estimated)
- First submitted
- 23 Oct 2024
- Start date
- 26 Jun 2025
- Primary completion date
- 31 Jul 2028
- Lead sponsor
- University of Pennsylvania
- Diseases
- Sickle cell disease
- NCT number
- NCT06665997
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 65
- From 26 Jun 2025 to the primary completion date, 31 Jul 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Chronic inflammatory conditions, such as lupus or inflammatory bowel disease
- History of VTE or stroke
- Current use of crizanlizumab, voxelotor, or chronic transfusion therapy, including simple transfusion and red cell exchange transfusion, history of hematopoietic stem cell transplantation
- Polycystic ovary syndrome or irregular periods
- Has a history or current evidence of any condition, therapy, or other circumstance that in the opinion of the investigator exposes the participant to risk through participating in the trial, may confound the results of the trial, or could interfere with participation for the full duration of the trial.
Other
- Current use of hormonal contraception or the copper intrauterine device
- Current pregnancy or pregnancy within the last 6 months
- Current lactation
- Blood pressure \>= 160 systolic or \>=100 diastolic at screening visit
Who the study is looking for
- Provision of signed and dated informed consent form
- Female, aged 18-50 years old
- Diagnosis of sickle cell disease (SS, SB0,SB+,SC)
- Report of at least 1 vaso-occlusive pain episode per month on average in the previous 6 months
- 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
- Willing to discontinue any hormonal contraception at the time of enrollment. Washout period of 1 month since last use of all hormonal contraception, and 4 months since most recent administration of depot medroxyprogesterone, is required prior to enrollment in the study.
- Have regular menstrual cycles (when not on hormonal contraception) with a usual length of 21 to 35 days.
- Stable dose of hydroxyurea and other sickle cell-related medications for the past 6 months
- Access to a device with text-messaging capability
- Must be able to read and understand English
- Willing to comply with study procedures
Age in the registry: 18 years to 50 years · Sex: Female · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Emory University Coordinator of this site? Confirm its status | Atlanta | United States | Not yet recruiting |
| Children's Hospital of Philadelphia Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.