RECRUITING

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

Conditions

Sickle Cell Disease (SCD)Vaso-Occlusive Pain Episode in Sickle Cell Disease Sickle Cell Disease Depot Medroxyprogesterone Acetate (Depo-Provera)Contraception Vaso-Occlusive Pain

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-06-26

Study Completion:2027-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06665997

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.

Ages Eligible for Study:18 Years to 50 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Arden McAllister, MPH

CONTACT

267-785-8044

arden.mcallister@pennmedicine.upenn.edu

Principal Investigator

Andrea Roe, MD MPH

PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Study Locations (Sites)

Emory University

Atlanta, Georgia, 30322

United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104

United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

Andrea Roe, MD MPH, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-26

Study Completion Date2027-10

Study Record Updates

Study Start Date2025-06-26

Study Completion Date2027-10

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

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