RECRUITING

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

Description

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

Study Details

Study overview

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.

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

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

Condition
Sickle Cell Disease (SCD)
Intervention / Treatment

-

Contacts and Locations

Atlanta

Emory University, Atlanta, Georgia, United States, 30322

Philadelphia

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States, 19104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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, emergency room visit, outpatient infusion visit) for sickle cell-related pain during the past year
  • 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. Stable dose of hydroxyurea and other sickle cell-related medications for the past 6 months
  • 8. Access to a device with text-messaging capability
  • 9. Must be able to read and understand English
  • 10. Willing to comply with study procedures
  • 1. Chronic inflammatory conditions, such as lupus or inflammatory bowel disease
  • 2. History of VTE or stroke
  • 3. Current use of crizanlizumab, voxelotor, or red cell exchange transfusion, or 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

Ages Eligible for Study

18 Years to 50 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Pennsylvania,

Andrea Roe, MD MPH, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

Study Record Dates

2027-10