Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:17 PM
Ignite Modification Date:
2025-12-24 @ 7:17 PM
NCT ID:
NCT02398903
Eligibility Criteria:
Eligibility Criteria:
Inclusion criteria :
* Obese women
* Obese women (BMI ≥ 35 kg/m² with obesity related comorbidity or BMI ≥ 40 kg/m²) with an indication of bariatric surgery by RYGB or sleeve gastrectomy under oral contraceptive treatment of interest in our study
* Aged 18 to 45 years if desogestrel or 18 to 35 years if COC
* Signed informed consent
* Affiliated to The French Social Security Health insurance
* Healthy Volunteers
* Normal weight (BMI \< 25 kg/m²)
* Women under oral contraceptive treatment
* Aged 18 to 45 years
* Signed informed consent
* Affiliated to The French Social Security Health insurance
Exclusion criteria :
* Drug treatment known to interact with cytochrome P450 (CYP3A4).
* Contraindication for an oral contraceptive agent as mentioned in the summary of product characteristics
* Positive pregnancy test
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT02398903
Study Brief:
Protocol Section:
NCT02398903