Changes in Body Composition and Sport Performance Among Young Female Soccer Players Using Subdermic Etonogestrel (Implanon NXT)
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Anthropometric Measurements
研究概览
简要总结
The goal of this clinical trial study is to evaluate the effect of subdermic etonogestrel implant on body composition, sport performance parameters, quantify bleeding patters and quality of life parameters among young female soccer players.
详细描述
Studies indicate a worsening of performance in young people with excessive menstrual bleeding and menstrual cramps. Hormonal contraception has been used to "manipulate" menstrual symptoms among physically active women, amateur and elite athletes. The use of the etonogestrel subdermal implant (Implanon NXT) would be a good option for young female soccer players. The goal of this study is to evaluate some parameters among young female soccer players under 17 years old during one year, in use of subdermic etonogestrel implant comparing with a non-users subdermic etonogestrel implant
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 17 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •sexually active women of childbearing potential, with no contraindications to the use of a progestogen and who agreed to participate in this study.
排除标准
- •breastfeeding, irregular vaginal bleeding, increased risk of thromboembolism, ischemic heart disease or other medical conditions
研究组 & 干预措施
Users of etonogestrel subdermic implant (ESI)
20 female soccer players, under 17 years, who choose subdermic etonogestrel implant (Implanon NXT) as contraceptive . IMPLANON NXT® 68mg (each implant contains 68 mg of etonogestrel) will be the intervention administered.
干预措施: Implanon NXT® subdermal implant (Device)
Users of etonogestrel subdermic implant (ESI)
20 female soccer players, under 17 years, who choose subdermic etonogestrel implant (Implanon NXT) as contraceptive . IMPLANON NXT® 68mg (each implant contains 68 mg of etonogestrel) will be the intervention administered.
干预措施: Etonogestrel 68mg implant (Drug)
结局指标
主要结局
Anthropometric Measurements
时间窗: Clinical, body composition and sport parameters will be evaluation before, 3, 6, 9 and 12 months after implant insertion.
Weight in kilograms
anthropometric measurements
时间窗: will be evaluated before, 3, 6, 9 and 12 months after implant insertion.
Weight (in kilograms) and height (in meters) will be used to obtain the BMI (body mass index) (kg/m²)
Body Composition
时间窗: Will be evaluation before, 3, 6, 9 and 12 months after implant insertion.
Weight in kilograms and skinfolds in millimeters will be used to measure the athletes' body composition (body composition is used to assess an individual's percentage of body fat and percentage of fat-free mass)
次要结局
- Sports Performance Parameters(sport parameters will be evaluation before, 3, 6, 9 and 12 months after implant insertion.)
- Sports performance parameters(Will be evaluated before, 3, 6, 9 and 12 months after implant insertion.)
研究者
Maíta Poli de Araújo
Assistant professor in the Department of Gynecology at Federal University of São Paulo
Federal University of São Paulo