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

NCT06775626 · Status: SUSPENDED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-08-14

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Organon

    collaborator INDUSTRY

  • Maíta Poli de Araújo

    lead OTHER

Principal Investigators

  • Maíta Poli Araújo, PhD · Federal University of São Paulo

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
17 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2025-04-01
Completion
2025-12-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • Brazil

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06775626 on ClinicalTrials.gov