Clinical trial NCT06665997: Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease
Official title: Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Sickle Cell Disease (SCD)
Vaso-Occlusive Pain Episode in Sickle Cell Disease
Keywords: Sickle Cell Disease
Depot Medroxyprogesterone Acetate (Depo-Provera)
Contraception
Vaso-Occlusive Pain
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2024-10-30
Enrollment: 65
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

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

Primary outcomes:
measure: Frequency of acute vaso-occlusive episodes
timeFrame: 6 months
Secondary outcomes:
measure: C-reactive protein
timeFrame: 6 months
measure: Hemoglobin
timeFrame: 6 months
measure: Reticulocyte count
timeFrame: 6 months
measure: Platelet count
timeFrame: 6 months
measure: Fetal hemoglobin
timeFrame: 6 months
measure: Bilirubin
timeFrame: 6 months
measure: D-dimer
timeFrame: 6 months
measure: von Willebrand factor
timeFrame: 6 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Andrea Roe, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: