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

NCT06665997 | Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: 8570391R01HL175726-01
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

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

Keywords

Sickle Cell Disease; Depot Medroxyprogesterone Acetate (Depo-Provera); Contraception; Vaso-Occlusive Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• C-reactive protein

  6 months

• Hemoglobin

  6 months

• Reticulocyte count

  6 months

• Platelet count

  6 months

• Fetal hemoglobin

  6 months

Study Arms (1)

Depot Medroxyprogesterone Acetate (Depo-Provera)

EXPERIMENTAL

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)

Interventions

Depot medroxyprogesterone acetate (DMPA) DRUG

150mg dose intramuscular administration of depot medroxyprogesterone acetate (DMPA) injectable suspension

Depot Medroxyprogesterone Acetate (Depo-Provera)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• Current use of hormonal contraception or the copper intrauterine device
• Current pregnancy or pregnancy within the last 6 months
• Current lactation
• Polycystic ovary syndrome or irregular periods
• Blood pressure \>= 160 systolic or \>=100 diastolic at screening visit
• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead
• Emory University: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Children's Hospital of Philadelphia: collaborator

Study Sites (2)

Emory University

Atlanta, Georgia, 30322, United States

NOT YET RECRUITING

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Andrea Roe, MD MPH

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arden McAllister, MPH

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: October 30, 2024
• Study Start: June 26, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: February 27, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Data will be made available starting 6 months after publication. There is no planned end date.
• Access Criteria: Researchers will obtain access through NHLBI Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) in accordance with their SOPs.

Locations

US (2)