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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Frequency of acute vaso-occlusive episodes [Срок оценки: 6 months]

Вторичные конечные точки (8)

• C-reactive protein [Срок оценки: 6 months]
• Hemoglobin [Срок оценки: 6 months]
• Reticulocyte count [Срок оценки: 6 months]
• Platelet count [Срок оценки: 6 months]
• Fetal hemoglobin [Срок оценки: 6 months]
• Bilirubin [Срок оценки: 6 months]
• D-dimer [Срок оценки: 6 months]
• von Willebrand factor [Срок оценки: 6 months]

Критерии участия

Критерии включения

• Provision of signed and dated informed consent form
• Female, aged 18-50 years old
• Diagnosis of sickle cell disease (SS, SB0,SB+,SC)
• Report of at least 1 vaso-occlusive pain episode per month on average in the previous 6 months
• 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
• 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.
• Have regular menstrual cycles (when not on hormonal contraception) with a usual length of 21 to 35 days.
• Stable dose of hydroxyurea and other sickle cell-related medications for the past 6 months
• Access to a device with text-messaging capability
• Must be able to read and understand English
• Willing to comply with study procedures

Критерии исключения

• Chronic inflammatory conditions, such as lupus or inflammatory bowel disease
• History of VTE or stroke
• Current use of crizanlizumab, voxelotor, or chronic transfusion therapy, including simple transfusion and red cell exchange transfusion, history of hematopoietic stem cell transplantation
• Current use of hormonal contraception or the copper intrauterine device
• Current pregnancy or pregnancy within the last 6 months
• Current lactation
• Polycystic ovary syndrome or irregular periods
• Blood pressure >= 160 systolic or >=100 diastolic at screening visit
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Emory University — Atlanta
• Children's Hospital of Philadelphia — Philadelphia

Идентификаторы

NCT: NCT06665997 · 857039 · 1R01HL175726-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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