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Menstrual SymptomsEarly Phase 1NCT06775626

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

A Early Phase 1 study testing Implanon NXT® subdermal implant and Etonogestrel 68mg implant in people with Menstrual Symptoms, run by Maíta Poli de Araújo at 1 site in Brazil.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 to 17 years, women onlyHealthy volunteers can take part
Conditions the study is for
Menstrual Symptoms
What is being tested?
Implanon NXT® subdermal implant and Etonogestrel 68mg implant
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteBrazil
Study dates
1 Apr 2025to Dec 2025
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 17 years
  • Women only
  • Healthy volunteers accepted
  • Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Department of Gynecology of Federal University of São Paulo

    São Paulo, 04023-062

Other trials in Brazil

About this study

Official title: Changes in Body Composition and Sport Performance Among Young Female Soccer Players Using Subdermic Etonogestrel (Implanon NXT)

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.

Read the 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

Being tested
Implanon NXT® subdermal implant, Etonogestrel 68mg implant
Keywords
menstrual symptoms, etonogestrel subdermal implant, female soccer players, young female athletes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Implanon NXT® subdermal implantDevice

    Also called Implanon NXT

    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

  • Etonogestrel 68mg implantDrug

    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

Study groups in NCT06775626
Study groupRoleWhat they receive
Users of etonogestrel subdermic implant (ESI)Experimental20 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.
Receives: Device: Implanon NXT® subdermal implant; Drug: Etonogestrel 68mg implant
Non users of etonogestrel subdermic implant (ESI)No intervention20 female soccer players without use of any hormonal contraceptive

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Anthropometric Measurements

    Weight in kilograms

    Measured: Clinical, body composition and sport parameters will be evaluation before, 3, 6, 9 and 12 months after implant insertion.

  2. anthropometric measurements

    skinfolds in millimeters

    Measured: Will be evaluation before, 3, 6, 9 and 12 months after implant insertion.

  3. anthropometric measurements

    Height in meters

    Measured: Will be evaluation before, 3, 6, 9 and 12 months after implant insertion.

  4. 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)

    Measured: Will be evaluation before, 3, 6, 9 and 12 months after implant insertion.

  5. anthropometric measurements

    Weight (in kilograms) and height (in meters) will be used to obtain the BMI (body mass index) (kg/m²)

    Measured: will be evaluated before, 3, 6, 9 and 12 months after implant insertion.

Secondary outcomes (2)

  1. Sports Performance Parameters

    • Kicking Tests : It consists of targets set on a goalkeeper divided into sectors with specific scores, and the numerical values reflect the accuracy of the shot.The goalkeeper is divided into 6 horizontal sectors, with scores assigned to each sector. For example:
    • Lower and central sectors: 2 points.
    • Upper and lateral sectors: 4 points.
    • Shots off goal: 0 points. The player takes 10 shots from within a delimited area (usually the penalty spot).The total points obtained in the 10 kicks are added together.

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

  2. Sports performance parameters

    Dribbling test: evaluates ball control and agility, challenging the player to maneuver the ball through obstacle courses in a limited time without losing control.The course is set up with cones spaced alternately in a straight line:

    • Cones positioned every 2 meters, totaling 5 cones on a 10 meter path.
    • The start and finish line is marked. Test Execution
    1. The athlete starts behind the starting line with the ball positioned on the ground.
    2. On command, the athlete dribbles the ball around the cones to the end line, returning to the starting point (round trip).
    3. The test is timed from start to finish. Scoring and Numerical Values
    • Total Time: Performance is recorded in seconds
    • Penalties:
    • Each cone dropped or incorrectly deflected adds 2 seconds to the final time.
    • Losing control of the ball outside the path adds 1 second per occurrence.
    • Evaluation Criteria: Excellent: ≤ 10 sec; Good:10.1 to 12 sec , Regular: 12.1 to 14 sec and Weak > 14

    Measured: Will be evaluated before, 3, 6, 9 and 12 months after implant insertion.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2025
  2. Study start1 Apr 2025
  3. Primary completion1 Apr 2025
  4. Study completionDec 2025 (estimated)

Why it stopped: The study was suspended due to non-compliance with the partnership agreement between the research team and the company that would supply Implanon. Therefore, it was not possible to continue the study

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
IMPLANON NXT® 68mg: Each implant contains 68 mg of etonogestrel.
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06775626
Sponsor's protocol ID
76907423.1.0000.5505
Status last verified
Aug 2025
First submitted
27 Dec 2024
Last updated
14 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No: The individual participant data (IPD) will not be authorized because the sample is made up of minors and the information collected is confidential. After the study is completed, the results will be duly published in accordance with ethical standards.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Implanon NXT® subdermal implant and Etonogestrel 68mg implant in people with Menstrual Symptoms, run by Maíta Poli de Araújo at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anthropometric Measurements (time frame: Clinical, body composition and sport parameters will be evaluation before, 3, 6, 9 and 12 months after implant insertion.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06775626.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.

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