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

Maíta Poli de Araújo

Status and phase: Suspended; Early Phase 1

Conditions: Menstrual Symptoms

Treatments: Device: Implanon NXT® subdermal implant; Drug: Etonogestrel 68mg implant

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06775626

76907423.1.0000.5505

Details and patient eligibility

About

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.

Full 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

Enrollment: 40 estimated patients

Sex: Female

Ages: 16 to 17 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Users of etonogestrel subdermic implant (ESI)

Experimental group

Description:

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.

Treatment:

Drug: Etonogestrel 68mg implant

Device: Implanon NXT® subdermal implant

Non users of etonogestrel subdermic implant (ESI)

No Intervention group

Description:

20 female soccer players without use of any hormonal contraceptive