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

Changes in Body Composition and Sport Performance Among Young Female Soccer Players Using Subdermic Etonogestrel (Implanon NXT)

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.

Study Overview

• Status: Suspended
• Conditions: Menstrual Symptoms
• Intervention / Treatment: Device: Implanon NXT® subdermal implant; Drug: Etonogestrel 68mg implant

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 04023-062
    • Department of Gynecology of Federal University of São Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Implanon NXT® subdermal implant; Each implant contains 68 mg of etonogestrel. The release rate is approximately 60-70 mcg/day in the 5th-6th week and reduces to approximately 35-45 mcg/day at the end of the first year; 30-40 mcg/day at the end of the second year and 25-30 mcg/day at the end of the third year. It will be evaluation before, 3, 6, 9 and 12 months after implant insertion.Participants' use of the device will be evaluated for one year; Other Names: Implanon NXT; Drug: Etonogestrel 68mg implant; Each implant contains 68 mg of etonogestrel. The release rate is approximately 60-70 mcg/day in the 5th-6th week and reduces to approximately 35-45 mcg/day at the end of the first year; 30-40 mcg/day at the end of the second year and 25-30 mcg/day at the end of the third year. It will be evaluation before, 3, 6, 9 and 12 months after implant insertion.Participants' use of the device will be evaluated for one year
No Intervention: Non users of etonogestrel subdermic implant (ESI); 20 female soccer players without use of any hormonal contraceptive

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anthropometric Measurements	Weight in kilograms	Clinical, body composition and sport parameters will be evaluation before, 3, 6, 9 and 12 months after implant insertion.
anthropometric measurements	skinfolds in millimeters	Will be evaluation before, 3, 6, 9 and 12 months after implant insertion.
anthropometric measurements	Height in meters	Will be evaluation before, 3, 6, 9 and 12 months after implant insertion.
Body Composition	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)	Will be evaluation before, 3, 6, 9 and 12 months after implant insertion.
anthropometric measurements	Weight (in kilograms) and height (in meters) will be used to obtain the BMI (body mass index) (kg/m²)	will be evaluated before, 3, 6, 9 and 12 months after implant insertion.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sports Performance Parameters	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.	sport parameters will be evaluation before, 3, 6, 9 and 12 months after implant insertion.
Sports performance parameters	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 ExecutionThe athlete starts behind the starting line with the ball positioned on the ground.On command, the athlete dribbles the ball around the cones to the end line, returning to the starting point (round trip).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	Will be evaluated before, 3, 6, 9 and 12 months after implant insertion.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bleeding pattern	The bleeding pattern will be classified as favorable or unfavorable: Favorable means regular menstrual cycle, between 21 and 35 days, lasting 3 to 7 days and the volume of blood loss does not bother the patient. Unfavorable means a cycle lasting less than 21 days, excessive bleeding lasting more than 7 days, intermenstrual bleeding	sport parameters will be evaluation before, 3, 6, 9 and 12 months after implant insertion.
Quality of life assessment	Quality of life will be measured through the application of the Brief Version in the World Health Organization Quality of Life Brief Version Questionnaire. It is a 26-item self-report questionnaire that assesses quality of life in four domains: physical health, psychological health, social relationships, and environment. Also includes two items that measure overall quality of life and general health. The World Health Organization Quality of Life Brief Version scale uses a 5-point Likert scale to score responses to 26 items. The scores are then transformed to a 0-100 scale, with 0 representing the worst possible health status and 100 representing the best	Quality of life will be evaluated before, 6 and 12 months after implant insertion.

Collaborators and Investigators

• Sponsor: Maíta Poli de Araújo
• Collaborators: Organon
• Investigators: Principal Investigator: Maíta Poli Araújo, PhD, Federal University of São Paulo

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Actual): April 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: December 27, 2024
• First Submitted That Met QC Criteria: January 9, 2025
• First Posted (Actual): January 15, 2025

Study Record Updates

• Last Update Posted (Actual): August 14, 2025
• Last Update Submitted That Met QC Criteria: August 11, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: menstrual symptoms; etonogestrel subdermal implant; female soccer players; young female athletes
• Additional Relevant MeSH Terms: Contraceptive Agents, Hormonal; Physiological Effects of Drugs; Reproductive Control Agents; Contraceptive Agents, Female; Contraceptive Agents; Etonogestrel
• Other Study ID Numbers: 76907423.1.0000.5505 (Registry Identifier: 76907423.1.0000.5505)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The individual participant data (IPD) will not be authorized because the sample is made up of minors and the information collected is confidential. After the study is completed, the results will be duly published in accordance with ethical standards.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes