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

NCT06665997 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2026-05-13

No results posted yet for this study

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

Interventions

DRUG

Depot medroxyprogesterone acetate (DMPA)

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

Sponsors & Collaborators

Principal Investigators

  • Andrea Roe, MD MPH · University of Pennsylvania

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-26
Primary Completion
2028-07-31
Completion
2028-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06665997 on ClinicalTrials.gov