Effects of the Contraceptive Implant in Women With Sickle Cell Disease
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Frequency of vaso-occlusive crises
研究概览
简要总结
The objective of this study is to measure the acceptability and impact of the progestin implant on frequency of vaso-occlusive crises, quality of life, and hematologic parameters in women with SCD.
详细描述
Sickle cell disease (SCD) is the most common inherited blood disorder in the United States, affecting 100,000 primarily Black people. The disease is characterized by chronic pain and infection, and ultimately reduces life expectancy by 20 years compared to people without SCD. Given the importance of effective contraception for women with sickle cell disease, as well as previously demonstrated therapeutic benefits of hormonal contraception, the etonogestrel implant may be an optimal method of contraception for women with SCD.
This study aims to measure the acceptability and impact of the progestin implant on frequency of vaso-occlusive crises, quality of life, and hematologic parameters in women with SCD.
This is a crossover study. Participants will be observed over two phases: 1) a 3-month phase with no hormonal contraceptive intervention and 2) a 6-month phase with the progestin implant. During the phase with no hormonal contraceptive intervention, participants must be willing to be abstinent or use a barrier method, or they must have had a permanent contraception procedure such as a tubal ligation or salpingectomy or be using the copper intrauterine device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female aged 18-45
- •Diagnosis of sickle cell disease (SS, SB 0, SB+, SC)
- •Report of at least 1 vaso-occlusive pain episode per month on average in the previous 6 months
- •Willing to discontinue any hormonal contraception at the time of enrollment. Washout period of 1 month required for all hormonal contraception prior to enrollment in the study.
- •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
- •Use of Depo Provera in the past 6 months
- •Changes to sickle cell medications in the past 3 months
- •Regular blood transfusions
- •History of hematopoeitic stem cell transplantation
- •Contraindications to use of Nexplanon device as per clinical standards (not including history of venous thromboemblosim [VTE])
- •Currently pregnant or pregnant within the last month or seeking to become pregnant
- •Currently breastfeeding
研究组 & 干预措施
Nexplanon
干预措施: Nexplanon 68 MG Drug Implant (Drug)
结局指标
主要结局
Frequency of vaso-occlusive crises
时间窗: 9 months
Self-reported pain crises, discrete pain episodes will be separated by at least 2 weeks
次要结局
未报告次要终点