Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease (SCD Depo)

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.

Study Overview

• Status: Recruiting
• Conditions: Sickle Cell Disease (SCD); Vaso-Occlusive Pain Episode in Sickle Cell Disease
• Intervention / Treatment: Drug: Depot medroxyprogesterone acetate (DMPA)

• Study Type: Interventional
• Enrollment (Estimated): 65
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Arden McAllister, MPH; Phone Number: 267-785-8044; Email: arden.mcallister@pennmedicine.upenn.edu

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Not yet recruiting
      • Emory University
      • Contact: Hailly Butler; Phone Number: 404-712-8895; Email: hailly.butler@emory.edu
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Children's Hospital of Philadelphia
      • Contact: Kandace Gollomp; Phone Number: 215-590-3535; Email: gollompk@chop.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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
11. Willing to comply with study procedures

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Depot Medroxyprogesterone Acetate (Depo-Provera); 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.	Drug: Depot medroxyprogesterone acetate (DMPA); 150mg dose intramuscular administration of depot medroxyprogesterone acetate (DMPA) injectable suspension

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of acute vaso-occlusive episodes	The primary outcome is frequency of VOEs during each phase (baseline and intervention). A VOE is self-reported by the participant. Discrete pain episodes will be separated by at least 2 weeks from one other. During both the baseline and intervention study phases, participants will provide weekly reports via electronic survey of vaso-occlusive pain. VOE will be defined as self-reported typical SCD pain that interferes with usual daily activities or requires emergency care or hospitalization, with distinct episodes separated by at least 2 weeks without pain.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
C-reactive protein	C-reactive protein will be measured from blood samples drawn twice, once during each study phase (baseline and intervention).	6 months
Hemoglobin	Hemoglobin will be measured from blood samples drawn twice, once during each study phase (baseline and intervention).	6 months
Reticulocyte count	Reticulocyte count will be measured from blood samples drawn twice, once during each study phase (baseline and intervention).	6 months
Platelet count	Platelet count will be measured from blood samples drawn twice, once during each study phase (baseline and intervention).	6 months
Fetal hemoglobin	Fetal hemoglobin will be measured from blood samples drawn twice, once during each study phase (baseline and intervention).	6 months
Bilirubin	Bilirubin will be measured from blood samples drawn twice, once during each study phase (baseline and intervention).	6 months
D-dimer	D-dimer will be measured from blood samples drawn twice, once during each study phase (baseline and intervention).	6 months
von Willebrand factor	von Willebrand factor will be measured from blood samples drawn twice, once during each study phase (baseline and intervention).	6 months

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Children's Hospital of Philadelphia; National Heart, Lung, and Blood Institute (NHLBI); Emory University
• Investigators: Principal Investigator: Andrea Roe, MD MPH, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2025
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028

Study Registration Dates

• First Submitted: October 23, 2024
• First Submitted That Met QC Criteria: October 28, 2024
• First Posted (Actual): October 30, 2024

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Contraception; Sickle Cell Disease; Depot Medroxyprogesterone Acetate (Depo-Provera); Vaso-Occlusive Pain
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Hematologic Diseases; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hemoglobinopathies; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hemic and Lymphatic Diseases; Anemia, Sickle Cell; Contraceptive Agents, Hormonal; Antineoplastic Agents; Physiological Effects of Drugs; Antineoplastic Agents, Hormonal; Reproductive Control Agents; Contraceptive Agents, Female; Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Hormonal; Contraceptives, Oral, Synthetic; Contraceptive Agents, Male; Medroxyprogesterone Acetate; Medroxyprogesterone
• Other Study ID Numbers: 857039; 1R01HL175726-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After the study is completed, the de-identified, archived data will be transmitted to the NHLBI Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) for use by other researchers including those outside of the study.
• IPD Sharing Time Frame: Data will be made available starting 6 months after publication. There is no planned end date.
• IPD Sharing Access Criteria: Researchers will obtain access through NHLBI Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) in accordance with their SOPs.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes