NCT06775626

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)

• Status: Suspended
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Maíta Poli de Araújo · Academic / Other
• Sex: Female
• Age: 16 Years – 17 Years
• Healthy volunteers: Accepted

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

Conditions

• Menstrual Symptoms

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2025-04-01
• Primary completion: 2025-04-01
• Completion: 2025-12-01
• First posted: 2025-01-15
• Last updated: 2025-08-14

Locations

1 site across 1 country: Brazil

Regulatory

• FDA-regulated drug study
• FDA-regulated device study