Recruiting

Depo-Provera

Sponsor:

University of Pennsylvania

Code:

NCT06665997

Conditions

Sickle Cell Disease (SCD)

Vaso-Occlusive Pain Episode in Sickle Cell Disease

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

Depot medroxyprogesterone acetate (DMPA)

Study Details

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.

Conditions

Sickle Cell Disease (SCD)

Vaso-Occlusive Pain Episode in Sickle Cell Disease

Study ID

NCT06665997

Start date

Jun 26, 2025

Status verified date

May, 2026

Completion date

Jul 31, 2028

Anticipated

Primary completion date

Jul 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

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, emergencyroom visit, outpatient infusion visit) for vaso-occlusive pain during the past year, unless approved by study PI Andrea Roe
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 chronic transfusion therapy, including simple transfusion and red cell exchange transfusion, 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
9. Has a history or current evidence of any condition, therapy, or other circumstance that in the opinion of the investigator exposes the participant to risk through participating in the trial, may confound the results of the trial, or could interfere with participation for the full duration of the trial.

Study Design

Enrollment

65 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

Depot medroxyprogesterone acetate (DMPA)

150mg dose intramuscular administration of depot medroxyprogesterone acetate (DMPA) injectable suspension

Primary outcome measure

  • Frequency of acute vaso-occlusive episodes [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Locations

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

More Information

Sponsor

University of Pennsylvania

Last update posted

May 28, 2026

Last verified

May, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-05-28.