Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Frequency of acute vaso-occlusive episodes
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Depot medroxyprogesterone acetate (DMPA) (Drug)
结局指标
主要结局
Frequency of acute vaso-occlusive episodes
时间窗: 6 months
The primary outcome is frequency of VOEs during each phase (baseline and intervention). A VOE is self-reported by the participant. Discrete pain episodes will be separated by at least 2 weeks from one other. During both the baseline and intervention study phases, participants will provide weekly reports via electronic survey of vaso-occlusive pain. VOE will be defined as self-reported typical SCD pain that interferes with usual daily activities or requires emergency care or hospitalization, with distinct episodes separated by at least 2 weeks without pain.
次要结局
- C-reactive protein(6 months)
- Hemoglobin(6 months)
- Reticulocyte count(6 months)
- Platelet count(6 months)
- Fetal hemoglobin(6 months)
- Bilirubin(6 months)
- D-dimer(6 months)
- von Willebrand factor(6 months)
研究者
Andrea Roe, MD, MPH
Assistant Professor of Obstetrics and Gynecology
University of Pennsylvania