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

Phase 4

Not yet recruiting

• Conditions: Sickle Cell Disease (SCD); Vaso-Occlusive Pain Episode in Sickle Cell Disease
• Interventions: Drug: Depot medroxyprogesterone acetate (DMPA)

• Registration Number: NCT06665997
• Lead Sponsor: University of Pennsylvania

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-23
• Study First Submitted QC: 2024-10-28
• Last Update Submitted: 2024-10-28
• Study First Posted: 2024-10-30
• Last Update Posted: 2024-10-30
• Study Start: 2024-12
• Primary Completion: 2028-04
• Study Completion: 2028-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 65

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, 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

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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 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Depot Medroxyprogesterone Acetate (Depo-Provera)	Depot medroxyprogesterone acetate (DMPA)	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.

Primary Outcome Measures

Name	Time	Method
Frequency of acute vaso-occlusive episodes	6 months	The primary outcome is frequency of VOEs during each phase (baseline and intervention). A VOE is self-reported by the participant. Discrete pain episodes will be separated by at least 2 weeks from one other.; During both the baseline and intervention study phases, participants will provide weekly reports via electronic survey of vaso-occlusive pain. VOE will be defined as self-reported typical SCD pain that interferes with usual daily activities or requires emergency care or hospitalization, with distinct episodes separated by at least 2 weeks without pain.

Secondary Outcome Measures

Name	Time	Method
C-reactive protein	6 months	C-reactive protein will be measured from blood samples drawn twice, once during each study phase (baseline and intervention).
Hemoglobin	6 months	Hemoglobin will be measured from blood samples drawn twice, once during each study phase (baseline and intervention).
Reticulocyte count	6 months	Reticulocyte count will be measured from blood samples drawn twice, once during each study phase (baseline and intervention).
Platelet count	6 months	Platelet count will be measured from blood samples drawn twice, once during each study phase (baseline and intervention).
Fetal hemoglobin	6 months	Fetal hemoglobin will be measured from blood samples drawn twice, once during each study phase (baseline and intervention).
Bilirubin	6 months	Bilirubin will be measured from blood samples drawn twice, once during each study phase (baseline and intervention).
D-dimer	6 months	D-dimer will be measured from blood samples drawn twice, once during each study phase (baseline and intervention).
von Willebrand factor	6 months	von Willebrand factor will be measured from blood samples drawn twice, once during each study phase (baseline and intervention).

Trial Locations

Locations (3)

Johns Hopkins Medical Center; 🇺🇸 Baltimore, Maryland, United States

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States