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长效醋酸甲羟孕酮对女性镰状细胞病患者的临床和生物标志物影响 (SCD Depo)

2026年11月2日 更新者：Andrea Roe, MD, MPH、University of Pennsylvania

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.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

65

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 美国
    • Georgia
      • Atlanta、Georgia、美国、30322
        • 尚未招聘
        • Emory University
        • 接触：
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19104
        • 招聘中
        • Children's Hospital of Philadelphia
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 50年 (成人)

接受健康志愿者

不

有资格学习的性别

女性

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
药品：Depot medroxyprogesterone acetate (DMPA)

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

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Frequency of acute vaso-occlusive episodes
大体时间：6 months

The primary outcome is frequency of VOEs during each phase (baseline and intervention). A VOE is self-reported by the participant.

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 one week without pain.
6 months

次要结果测量

结果测量
措施说明
大体时间
C-reactive protein
大体时间：6 months

C-reactive protein will be measured from blood samples drawn twice, once during each study phase (baseline and intervention).
6 months
Hemoglobin
大体时间：6 months

Hemoglobin will be measured from blood samples drawn twice, once during each study phase (baseline and intervention).
6 months
Reticulocyte count
大体时间：6 months

Reticulocyte count will be measured from blood samples drawn twice, once during each study phase (baseline and intervention).
6 months
Platelet count
大体时间：6 months

Platelet count will be measured from blood samples drawn twice, once during each study phase (baseline and intervention).
6 months
Fetal hemoglobin
大体时间：6 months

Fetal hemoglobin will be measured from blood samples drawn twice, once during each study phase (baseline and intervention).
6 months
Bilirubin
大体时间：6 months

Bilirubin will be measured from blood samples drawn twice, once during each study phase (baseline and intervention).
6 months
D-dimer
大体时间：6 months

D-dimer will be measured from blood samples drawn twice, once during each study phase (baseline and intervention).
6 months
von Willebrand factor
大体时间：6 months

von Willebrand factor will be measured from blood samples drawn twice, once during each study phase (baseline and intervention).
6 months
Pain intensity
大体时间：6 months

Pain intensity, as measured by the PROMIS Pain Intensity 1a Numeric Rating Scale, comparing baseline and intervention phases.
6 months
Pain intensity
大体时间：6 months

Pain intensity, as measured by the PROMIS Pain Intensity 3a scale, comparing baseline and intervention phases.
6 months
Pain interference
大体时间：6 months

PROMIS pain interference 8a scale, comparing baseline and intervention phases.
6 months
Number of vaso-occlusive pain days
大体时间：6 months

Number of vaso-occlusive pain days as measured in the study diary, comparing baseline and intervention phases.
6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Pennsylvania

合作者

Children's Hospital of Philadelphia
National Heart, Lung, and Blood Institute (NHLBI)
Emory University

调查人员

  • 首席研究员：Andrea Roe, MD MPH、University of Pennsylvania

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年6月26日

初级完成 (估计的)

2028年7月31日

研究完成 (估计的)

2028年7月31日

研究注册日期

首次提交

2024年10月23日

首先提交符合 QC 标准的

2024年10月28日

首次发布 (实际的)

2024年10月30日

研究记录更新

最后更新发布 (实际的)

2026年11月5日

上次提交的符合 QC 标准的更新

2026年11月2日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 857039
  • 1R01HL175726-01 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

After the study is completed, the de-identified, archived data will be transmitted to the NHLBI Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) for use by other researchers including those outside of the study.

IPD 共享时间框架

Data will be made available starting 6 months after publication. There is no planned end date.

IPD 共享访问标准

Researchers will obtain access through NHLBI Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) in accordance with their SOPs.

IPD 共享支持信息类型

  • 研究方案
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

是的

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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