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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
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| Name | Class |
|---|---|
| Organon | INDUSTRY |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Users of etonogestrel subdermic implant (ESI) | Experimental | 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. |
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| Non users of etonogestrel subdermic implant (ESI) | No Intervention | 20 female soccer players without use of any hormonal contraceptive |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implanon NXT® subdermal implant | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Anthropometric Measurements | Weight in kilograms | Clinical, body composition and sport parameters will be evaluation before, 3, 6, 9 and 12 months after implant insertion. |
| anthropometric measurements | skinfolds in millimeters | Will be evaluation before, 3, 6, 9 and 12 months after implant insertion. |
| anthropometric measurements | Height in meters | Will be evaluation before, 3, 6, 9 and 12 months after implant insertion. |
| 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) | Will be evaluation before, 3, 6, 9 and 12 months after implant insertion. |
| anthropometric measurements | Weight (in kilograms) and height (in meters) will be used to obtain the BMI (body mass index) (kg/m²) | will be evaluated before, 3, 6, 9 and 12 months after implant insertion. |
| Measure | Description | Time Frame |
|---|---|---|
| Sports Performance Parameters |
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| Measure | Description | Time Frame |
|---|---|---|
| Bleeding pattern | The bleeding pattern will be classified as favorable or unfavorable: Favorable means regular menstrual cycle, between 21 and 35 days, lasting 3 to 7 days and the volume of blood loss does not bother the patient. Unfavorable means a cycle lasting less than 21 days, excessive bleeding lasting more than 7 days, intermenstrual bleeding | sport parameters will be evaluation before, 3, 6, 9 and 12 months after implant insertion. |
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:
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| Name | Affiliation | Role |
|---|---|---|
| Maíta Poli Araújo, PhD | Federal University of São Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gynecology of Federal University of São Paulo | São Paulo | 04023-062 | Brazil |
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.
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| ID | Term |
|---|---|
| C044815 | etonogestrel |
| D004343 | Drug Implants |
| ID | Term |
|---|---|
| D003692 | Delayed-Action Preparations |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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IMPLANON NXT® 68mg:
Each implant contains 68 mg of etonogestrel.
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| Etonogestrel 68mg implant | Drug | 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 |
|
| sport parameters will be evaluation before, 3, 6, 9 and 12 months after implant insertion. |
| 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:
| Will be evaluated before, 3, 6, 9 and 12 months after implant insertion. |
| Quality of life assessment | Quality of life will be measured through the application of the Brief Version in the World Health Organization Quality of Life Brief Version Questionnaire. It is a 26-item self-report questionnaire that assesses quality of life in four domains: physical health, psychological health, social relationships, and environment. Also includes two items that measure overall quality of life and general health. The World Health Organization Quality of Life Brief Version scale uses a 5-point Likert scale to score responses to 26 items. The scores are then transformed to a 0-100 scale, with 0 representing the worst possible health status and 100 representing the best | Quality of life will be evaluated before, 6 and 12 months after implant insertion. |