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

NCT06775626 | Suspended Early Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: 76907423.1.0000.5505
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Menstrual Symptoms

Keywords

menstrual symptoms; etonogestrel subdermal implant; female soccer players; young female athletes

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• 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.

Other Outcomes (2)

• Bleeding pattern

  sport parameters will be evaluation before, 3, 6, 9 and 12 months after implant insertion.

• Quality of life assessment

  Quality of life will be evaluated before, 6 and 12 months after implant insertion.

Study Arms (2)

Users of etonogestrel subdermic implant (ESI)

EXPERIMENTAL

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; Drug: Etonogestrel 68mg implant

Non users of etonogestrel subdermic implant (ESI)

NO INTERVENTION

20 female soccer players without use of any hormonal contraceptive

Interventions

Implanon NXT® subdermal implant DEVICE

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

Also known as: Implanon NXT

Users of etonogestrel subdermic implant (ESI)

Etonogestrel 68mg implant DRUG

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

Users of etonogestrel subdermic implant (ESI)

Eligibility Criteria

• Age: 16 Years - 17 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Maíta Poli de Araújo: lead
• Organon: collaborator

Study Sites (1)

Department of Gynecology of Federal University of São Paulo

São Paulo, 04023-062, Brazil

Location

MeSH Terms

Interventions

etonogestrel; Drug Implants

Intervention Hierarchy (Ancestors)

Delayed-Action Preparations; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Maíta Poli Araújo, PhD

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor in the Department of Gynecology at Federal University of São Paulo

Model Details: IMPLANON NXT® 68mg: Each implant contains 68 mg of etonogestrel.

Study Record Dates

• First Submitted: December 27, 2024
• First Posted: January 15, 2025
• Study Start: April 1, 2025
• Primary Completion: April 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)