Evaluation of Anterior Tibial Translation of the Knee in Healthy Women, at Two Times of the Menst… (NCT05177549) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Anterior Tibial Translation of the Knee in Healthy Women, at Two Times of the Menstrual Cycle, on Hormonal Contraceptives or Not (FLEX)
France45 participantsStarted 2022-06-08
Plain-language summary
Women's participation in sports at all levels has been increasing in recent decades. Many individual and team sports are at risk of anterior cruciate ligament (ACL) injury. This injury leads to a permanent or long-lasting interruption of sports practice and to significant medical and economic expenses. Women are recognized as being more at risk of anterior cruciate ligament injury with a risk 6 times higher than men. Hyperlaxity is a risk factor for anterior cruciate ligament injury, but the pathophysiological bases are little studied. Hormonal impregnation and certain periods of the menstrual cycle (ovulatory phase) are risk factors for anterior cruciate ligament injury. It therefore seems interesting to investigators to study the influence of hormonal impregnation on ligament laxity. To date no study has investigated such a relationship.
Who can participate
Age range
18 Years – 40 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Woman between 18 and 40 years old
* No history of surgery of the 2 lower limbs
* No change in contraceptive method in the last 6 months
* Signature of the informed consent
* Affiliation to the social security system
* To be at Day 14 of her menstrual cycle (+/-1 day) (the first day of the cycle (Day1) being considered as the first day of the menstrual period), except for those on micro-progestative contraception not regulated
By inclusion group:
\- For women without hormonal contraception: No method of contraception Or a copper intrauterine device Regular cycles of 26 to 33 days
\- For women on estrogen-progestin contraception: Correct use of the estrogen-progestin pill according to the MA Or wearing a vaginal ring according to the MA protocol Or wearing a contraceptive skin patch according to the MA protocol Regular cycles of 26 to 33 days
\- For women on micro-progestin contraception : Continuous use of the micro-progestogen pill Or wearing a subcutaneous hormonal implant,
Exception: women on micro-progestin contraception who are not regulated:
* They may have an irregular cycle or no cycle to be included
* They can be included on any day if they have no cycle
Exclusion Criteria:
* Pregnancy or breastfeeding in progress
* Hormonal intrauterine device or injectable contraception
* Menopause (defined as no menstruation for one year)
* Surgery: tubal ligation, oophorectomy, adnexectomy, hysterectomy
* History of microcrystalline or infectious pat…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.