Relationship Between Drug Exposure and DNA Markers With Depot Medroxyprogesterone Acetate-associated Side Effects in Adolescents
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Baseline to 48 Weeks
研究概览
简要总结
The investigators are doing this study to look at how different doses of the Depot medroxyprogesterone acetate (DMPA) shot effect weight gain and bone mineral density in teens. The investigators hope that what the investigators learn from this study will be used to develop ways to keep girls from gaining weight or losing bone density when receiving DMPA.
详细描述
Depot medroxyprogesterone acetate (DMPA) is a generic form of the DepoProvera® shot. When receiving the birth control shot some girls gain a lot of weight while others do not. Some girls also lose bone mineral density (BMD). Bone mineral density is the amount of weight and thickness of the bones.
In this study 1 of 3 doses of DMPA will be given as an injection into the muscle in the arm. The 150mg dose is approved for use in this age group by the Food and Drug Administration (FDA) when given into the muscle. The 104mg dose is approved for use in this age group by the FDA only when given under the skin therefore it is considered experimental. The 75mg dose is also considered experimental as this dose is not FDA approved regardless of how it is given.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 21 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 12-21 years
- •Healthy, post-menarcheal female
- •Self-selected to initiate depot medroxyprogesterone acetate (DMPA)
- •Willingness to use a barrier method of contraception in addition to DMPA
排除标准
- •Chronic disease known to affect weight or bone mineral density (BMD) (e.g. diabetes, kidney)
- •Use of medication known to affect weight or BMD (e.g. corticosteroids)
- •DMPA use within the past 12 months
- •Pregnancy within the past 6 months
- •Etonogestrel implant, levonorgestrel-releasing intrauterine system or combined estrogen/progesterone contraceptive use within the past 30 days (OC, patch, vaginal ring)
- •Weight exceeding 450 lbs
- •Need for confidential contraceptive care for individuals < 18 years of age.
研究组 & 干预措施
150 mg DMPA
Depot medroxyprogesterone acetate (DMPA) 150 mg every 12 weeks IM
干预措施: Depot medroxyprogesterone acetate (DMPA) (Drug)
104mg DMPA
Depot medroxyprogesterone acetate (DMPA) 104 mg every 12 weeks IM
干预措施: Depot medroxyprogesterone acetate (DMPA) (Drug)
75mg DMPA
Depot medroxyprogesterone acetate (DMPA) 75 mg every 12 weeks IM
干预措施: Depot medroxyprogesterone acetate (DMPA) (Drug)
结局指标
主要结局
Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Baseline to 48 Weeks
时间窗: Percent change from baseline to 48 Weeks
Lumbar spine bone mineral density measured at baseline and 48 weeks. Percent change over this time was calculated.
Proportion of Participants With >5% Weight Gain at 24 Weeks
时间窗: Week 24
Individual subjects will be assessed after their Week 24 visit.
次要结局
- Percent Change in Total Hip BMD From Baseline to 48 Weeks(Percent change from baseline to 48 weeks)
研究者
Andrea Bonny
Assistant Professor, Department of Pediatrics, The Ohio State University
Nationwide Children's Hospital