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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: f
View:

• 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, emergency room visit, outpatient infusion visit) for sickle cell-related pain during the past year

• 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.

• 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

Locations
United States
Georgia
Emory University
NOT_YET_RECRUITING
Atlanta
Pennsylvania
Children's Hospital of Philadelphia
RECRUITING
Philadelphia
Contact Information
Primary
Arden McAllister, MPH
arden.mcallister@pennmedicine.upenn.edu
267-785-8044
Time Frame
Start Date: 2025-06-26
Estimated Completion Date: 2027-10
Participants
Target number of participants: 65
Treatments
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.
Sponsors
Collaborators: Emory University, Children's Hospital of Philadelphia, National Heart, Lung, and Blood Institute (NHLBI)
Leads: University of Pennsylvania

This content was sourced from clinicaltrials.gov