Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease (SCD Depo)

University of Pennsylvania

Status and phase: Enrolling; Phase 4

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

Treatments: Drug: Depot medroxyprogesterone acetate (DMPA)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06665997

857039

1R01HL175726-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 65 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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. 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 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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65 participants in 1 patient group

Depot Medroxyprogesterone Acetate (Depo-Provera)

Experimental group

Description:

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.

Treatment:

Drug: Depot medroxyprogesterone acetate (DMPA)