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RECRUITINGPHASE4

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

NCT06665997•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

18 - 50 years

Sex

FEMALE

Healthy Volunteers

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 hormonal contraception, and 4 months since most recent administration of depot medroxyprogesterone, is required prior to enrollment in the study.
•7. Have regular menstrual cycles (when not on hormonal contraception) with a usual length of 21 to 35 days.
•8. Stable dose of hydroxyurea and other sickle cell-related medications for the past 6 months
•9. Access to a device with text-messaging capability
•10. Must be able to read and understand English
+1 more criteria

Exclusion Criteria

•1. Chronic inflammatory conditions, such as lupus or inflammatory bowel disease
•2. History of VTE or stroke
•3. Current use of crizanlizumab, voxelotor, or chronic transfusion therapy, including simple transfusion and red cell exchange transfusion, history of hematopoietic stem cell transplantation
•4. Current use of hormonal contraception or the copper intrauterine device
•5. Current pregnancy or pregnancy within the last 6 months
•6. Current lactation
•7. Polycystic ovary syndrome or irregular periods
•8. Blood pressure \>= 160 systolic or \>=100 diastolic at screening visit
•9. 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.

Locations (2)

Emory University

Atlanta, Georgia, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

June 26, 2025

Primary Completion Date

October 1, 2027

Completion Date

October 1, 2027

Last Updated

February 27, 2026

Enrollment

ESTIMATED participants

Conditions

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

Interventions

Depot medroxyprogesterone acetate (DMPA)

DRUG

Contacts

Arden McAllister, MPH

CONTACT

267-785-8044 arden.mcallister@pennmedicine.upenn.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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