Ignite Creation Date:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2025-12-31 @ 4:36 PM
Study NCT ID:
NCT05028959
Status:
UNKNOWN
Last Update Posted:
2021-08-31
First Post:
2021-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hormonal Status, Performance and Health in Elite Female Athlete
Sponsor:
Université Paris-Saclay-Assistance publique des hôpitaux de Paris
Organization:
Study Overview
Official Title:
Menstrual Cycle, Amenorrhea and Contraception in Elite Female Athletes: Impact on Performance, Health and the Athlete's Biological Passport
Status:
UNKNOWN
Status Verified Date:
2021-08
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FEMMES
Brief 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
* 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
Detailed 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)
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)
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: