Depo-Provera (depot medroxyprogesterone acetate) for pain and biomarker changes in women with sickle cell disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adult women with sickle cell disease who have regular menstrual cycles and frequent vaso-occlusive pain will complete a three-month baseline period without hormonal contraception. Participants will then receive a single injection of depot medroxyprogesterone acetate and be followed for three months to see changes in pain frequency, severity, and blood biomarkers. The protocol includes 6–7 in-person visits for urine pregnancy tests, blood draws, and surveys, plus weekly remote surveys and monthly home pregnancy tests. Study entry requires stable sickle cell medications and willingness to stop other hormonal contraception for the washout period and duration of the study.

Why it matters

Who can join: the full rules

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.

Where it's running

• Children's Hospital of Philadelphia
  Philadelphia, Pennsylvania, United States Recruiting
• Emory University
  Atlanta, Georgia, United States Not yet recruiting

Study contacts

• Principal investigator: Andrea Roe, MD MPH — University of Pennsylvania
• Study coordinator: Arden McAllister, MPH
• Email: arden.mcallister@pennmedicine.upenn.edu
• Phone: 267-785-8044

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Sickle cell disease registry at Ain Shams University

  This project creates an Ain Shams University registry of children and young people with sickle cell disease to track their health over time without providing a treatment.

  Recruiting Ain Shams University · Cairo and 1 other locations · NCT07800247

• Point-of-care newborn SCD screening and early care in Côte d'Ivoire

  This trial tests whether using a Gazelle-Multispectral point-of-care test at birth plus early, comprehensive SCD care can reduce illnesses and deaths for babies with SCD in the first years of life.

  Recruiting Phase 4 Swiss Tropical & Public Health Institute · Abidjan and 1 other locations · NCT07488520

• Low-dose ketamine for sickle cell vaso-occlusive pain in children and young adults

  This trial will test whether adding a low (sub-dissociative) dose ketamine infusion to usual IV opioid pain medicine helps children and young adults (ages 5–20) with sickle cell disease have better pain relief and remain safe during a vaso-occlusive episode.

  Recruiting Phase 2 Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center · Torrance, California · NCT07369024

• Lidocaine to Help Spare Opioids During Vaso-occlusive Crises in Sickle Cell Disease

  This study tests whether adding lidocaine to standard pain care during a vaso-occlusive crisis can reduce the total opioid use in adults with sickle cell disease.

  Recruiting at 12 sites Phase 3 Nantes University Hospital · Bordeaux and 11 other locations · NCT07274254

• Sickle Cell Kidney Sample Bank

  This project will collect blood and urine from adults with sickle cell disease or sickle cell trait to see if linked samples and medical records can help researchers learn how kidney disease starts and progresses.

  Recruiting at 2 sites University of Texas Southwestern Medical Center · Dallas, Texas and 1 other locations · NCT07064174

• Comparing stem cell transplantation to disease-modifying therapy for children with sickle cell disease

  This study is trying to see how well stem cell transplants work compared to other treatments for children with sickle cell disease over three years.

  Recruiting at 16 sites University of Rochester · Birmingham, Alabama and 36 other locations · NCT06941389

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.