Hormonal Status, Performance and Health in Elite Female Athlete — FEMMES  

Healthy Clinical Trial

Official title: Menstrual Cycle, Amenorrhea and Contraception in Elite Female Athletes: Impact on Performance, Health and the Athlete's Biological Passport

Status Not yet recruiting

Clinical Trial Summary

The repercussions of the hormonal status of high-level sportswomen on their performance and health as well as on the Athlete's Biological Passport (ABP) have been little studied and remain poorly known. The investigators therefore propose to contribute to the improvement of current knowledge by determining, thanks to the implementation of a multidisciplinary monitoring, with the use of various tests and matrices, in female elite athletes and recreational athletes (control group):

• 1) the impact of cycle phase, absence of cycle or contraceptive use on physical and psychological performance, health as well as on ABP;

• 2) the potential confounding effects of the athlete's environment

• 3) correlations between the different matrices analyzed

Clinical Trial Description

Volunteers to be studied: 80 healthy female subjects (16 to 30 years old), divided into 2 groups:

Group 1: 60 athletes, from different sports disciplines, in amenorrhea, with menstrual cycle or taking contraceptives

Group 2: 20 leisure sports subjects with menstrual cycle or taking contraceptives

Following the oral and written information of the project, the subjects have a minimum of 15 days of reflection before signing the written consent form. They will have the possibility, at any time, to voluntarily interrupt the study without having to justify themselves.

Investigations to be performed:

1. Annual complete clinical examination :

2. "Out-of-competition" follow-up, time frame 6 months

• medical, nutritional and respiratory monitoring

• biological monitoring

• psychological monitoring

• performance monitoring

3. Non-invasive "in-competition" monitoring, only for Group 1, once in a year on the day before/after a major competition:

• biological monitoring

• psychological monitoring

• performance monitoring (interview) ;

Related Conditions & MeSH terms

• Amenorrhea
• Healthy

• NCT number: NCT05028959
• Study type: Interventional
• Source: Université Paris-Saclay-Assistance publique des hôpitaux de Paris
• Contact: Emmanuelle DURON, PU-PH
• Phone: 33144083503
• Email: emmanuelle.duron@aphp.fr
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 15, 2021
• Completion date: May 31, 2025