Body Composition and Sport Performance Among Young Female Soccer Players Using Subdermic Etonogestrel

Early Phase 1

Not yet recruiting

• Conditions: Menstrual Symptoms
• Interventions: Device: Implanon NXT® subdermal implant; Drug: Etonogestrel 68mg implant

• Registration Number: NCT06775626
• Lead Sponsor: Maíta Poli de Araújo

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2024-12-27
• Study First Submitted QC: 2025-01-09
• Study First Posted: 2025-01-15
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-19
• Study Start: 2025-04
• Primary Completion: 2025-04
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• sexually active women of childbearing potential, with no contraindications to the use of a progestogen and who agreed to participate in this study.

Exclusion Criteria

• breastfeeding, irregular vaginal bleeding, increased risk of thromboembolism, ischemic heart disease or other medical conditions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Users of etonogestrel subdermic implant (ESI)	Implanon NXT® subdermal implant	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.
Users of etonogestrel subdermic implant (ESI)	Etonogestrel 68mg implant	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.

Primary Outcome Measures

Name	Time	Method
Anthropometric Measurements	Clinical, body composition and sport parameters will be evaluation before, 3, 6, 9 and 12 months after implant insertion.	Weight in kilograms
anthropometric measurements	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	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)

Secondary Outcome Measures

Name	Time	Method
Sports Performance Parameters	sport parameters will be evaluation before, 3, 6, 9 and 12 months after implant insertion.	* Kicking Tests : It consists of targets set on a goalkeeper divided into sectors with specific scores, and the numerical values reflect the accuracy of the shot.The goalkeeper is divided into 6 horizontal sectors, with scores assigned to each sector. For example: * Lower and central sectors: 2 points.; * Upper and lateral sectors: 4 points.; * Shots off goal: 0 points. The player takes 10 shots from within a delimited area (usually the penalty spot).The total points obtained in the 10 kicks are added together.
Sports performance parameters	Will be evaluated before, 3, 6, 9 and 12 months after implant insertion.	Dribbling test: evaluates ball control and agility, challenging the player to maneuver the ball through obstacle courses in a limited time without losing control.The course is set up with cones spaced alternately in a straight line: * Cones positioned every 2 meters, totaling 5 cones on a 10 meter path.; * The start and finish line is marked. Test Execution; 1. The athlete starts behind the starting line with the ball positioned on the ground.; 2. On command, the athlete dribbles the ball around the cones to the end line, returning to the starting point (round trip).; 3. The test is timed from start to finish. Scoring and Numerical Values; * Total Time: Performance is recorded in seconds; * Penalties: * Each cone dropped or incorrectly deflected adds 2 seconds to the final time.; * Losing control of the ball outside the path adds 1 second per occurrence.; * Evaluation Criteria: Excellent: ≤ 10 sec; Good:10.1 to 12 sec , Regular: 12.1 to 14 sec and Weak \> 14

Trial Locations

Locations (1)

Department of Gynecology of Federal University of São Paulo; 🇧🇷 São Paulo, Brazil