Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease
NCT ID: NCT06665997
Last Updated: 2026-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
65 participants
INTERVENTIONAL
2025-06-26
2027-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Depot medroxyprogesterone acetate (DMPA)
150mg dose intramuscular administration of depot medroxyprogesterone acetate (DMPA) injectable suspension
Interventions
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Depot medroxyprogesterone acetate (DMPA)
150mg dose intramuscular administration of depot medroxyprogesterone acetate (DMPA) injectable suspension
Eligibility Criteria
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Inclusion Criteria
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. 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
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
18 Years
50 Years
FEMALE
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Emory University
OTHER
Children's Hospital of Philadelphia
OTHER
University of Pennsylvania
OTHER
Responsible Party
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Andrea Roe, MD, MPH
Assistant Professor of Obstetrics and Gynecology
Principal Investigators
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Andrea Roe, MD MPH
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
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Emory University
Atlanta, Georgia, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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857039
Identifier Type: -
Identifier Source: org_study_id
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