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:
2025-12-26 @ 10:43 PM
Ignite Modification Date:
2025-12-26 @ 10:43 PM
NCT ID:
NCT06245512
Eligibility Criteria:
Inclusion Criteria:
For all participants:
Women 18-45 of age who
* Have their period
* Have given their written consent
* Have already used a menstrual cup as a method of hygienic protection
* Residing or working in Ile de France (Paris Metropolitan area, France)
For participants with endometriosis:
* diagnosis of endometriosis established by surgery or imaging (ultrasound and/or MRI)
* presence of one or more painful symptoms \> 3 on a visual scale (dysmenorrhea and/or dyspareunia and/or chronic pelvic pain) and/or infertility
* for the surgery subgroup: planned surgery in the next 3 months
For participants without endometriosis:
* painful symptoms \< or equal to 3 on a visual scale (for dysmenorrhea and dyspareunia and chronic pelvic pain),
* absence of intense period pain in adolescence (leading to taking pills to control this pain and/or peri-menstrual school absenteeism)
Exclusion Criteria:
For all participants:
* Autoimmune diseases
* Chronic diseases other than endometriosis (diabetes, hypertension)
* A person who is the subject of a judicial safeguard measure (by declaration)
* Infectious diseases (HIV, HBV, if known)
* History of menstrual toxic shock syndrome
For patients with endometriosis:
* endometriosis surgery within the last 3 months.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT06245512
Study Brief:
Protocol Section:
NCT06245512