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RecruitingPhase 4

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 50 Years
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether Depo-Provera, a birth control shot, can reduce sickle cell pain. It is for women ages 18–50 with sickle cell disease who have regular pain episodes. Participants spend 3 months without hormonal birth control, then have 3 months of follow-up after the shot.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be a woman age 18–50 with sickle cell disease type SS, SB0, SB+, or SC.
  • Have an average of at least 1 sickle cell pain episode a month over the past 6 months. These episodes happen when blood flow is blocked.
  • Have 1–10 medical visits for sickle cell pain in the past year, unless the study leader approves an exception.
  • Be willing to stop hormonal birth control. Before joining, wait at least 1 month after other hormonal birth control or 4 months after a Depo-Provera shot.
  • Have regular periods, with cycles usually lasting 21–35 days when not using hormonal birth control.
  • Have no dose changes in hydroxyurea or other sickle cell medicines for the past 6 months.
  • Have access to a device that can send and receive texts, and be able to read and understand English.
  • Sign and date a consent form and agree to follow study steps, including visits, blood draws, surveys, and pregnancy tests.

Who can't join

  • Have a long-term illness that causes inflammation, such as lupus or inflammatory bowel disease.
  • Have had a blood clot in a vein or a stroke.
  • Currently use crizanlizumab or voxelotor, receive regular blood transfusions or red blood cell exchanges, or have had a blood-forming stem cell transplant.
  • Currently use hormonal birth control or a copper IUD, a birth control device placed in the womb.
  • Are pregnant, were pregnant in the past 6 months, or are breastfeeding.
  • Have polycystic ovary syndrome, a hormone condition, or irregular periods.
  • Have blood pressure with a top number of 160 or higher or a bottom number of 100 or higher at screening.
  • Have another condition, treatment, or situation that the study doctor thinks could make the study unsafe, affect its results, or prevent you from finishing.

Simplified for readability. The official criteria below are what the study team uses.

Official 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, 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 sites (2)

GA

PA