Clinical trial NCT06775626: Body Composition and Sport Performance Among Young Female Soccer Players Using Subdermic Etonogestrel
Official title: Changes in Body Composition and Sport Performance Among Young Female Soccer Players Using Subdermic Etonogestrel (Implanon NXT)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Menstrual Symptoms
Keywords: menstrual symptoms
etonogestrel subdermal implant
female soccer players
young female athletes
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Organon
First posted: 2025-01-15
Enrollment: 40
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: IMPLANON NXT® 68mg:

Each implant contains 68 mg of etonogestrel.
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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

Primary outcomes:
measure: Anthropometric Measurements
timeFrame: Clinical, body composition and sport parameters will be evaluation before, 3, 6, 9 and 12 months after implant insertion.
measure: anthropometric measurements
timeFrame: Will be evaluation before, 3, 6, 9 and 12 months after implant insertion.
measure: anthropometric measurements
timeFrame: Will be evaluation before, 3, 6, 9 and 12 months after implant insertion.
measure: Body Composition
timeFrame: Will be evaluation before, 3, 6, 9 and 12 months after implant insertion.
measure: anthropometric measurements
timeFrame: will be evaluated before, 3, 6, 9 and 12 months after implant insertion.
Secondary outcomes:
measure: Sports Performance Parameters
timeFrame: sport parameters will be evaluation before, 3, 6, 9 and 12 months after implant insertion.
measure: Sports performance parameters
timeFrame: Will be evaluated before, 3, 6, 9 and 12 months after implant insertion.
Other outcomes:
measure: Bleeding pattern
timeFrame: sport parameters will be evaluation before, 3, 6, 9 and 12 months after implant insertion.
measure: Quality of life assessment
timeFrame: Quality of life will be evaluated before, 6 and 12 months after implant insertion.
Locations:
city: São Paulo
country: Brazil
facility: Department of Gynecology of Federal University of São Paulo
Study officials:
affiliation: Federal University of São Paulo
name: Maíta Poli Araújo, PhD
role: PRINCIPAL_INVESTIGATOR
References: