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:
2025-12-25 @ 2:58 AM
Ignite Modification Date:
2025-12-25 @ 2:58 AM
NCT ID:
NCT06019533
Eligibility Criteria:
Inclusion Criteria:
* At Visit 1a, subjects must meet ALL of the following criteria:
1. Sexually active, postmenarcheal and premenopausal female subjects at risk of pregnancy including breastfeeding women.
2. Women who either
1. have never used hormonal contraceptives before consent/assent (naïve users), or
2. have used hormonal contraceptives in the past, but have had a hormonal contraceptive-free period before consent/assent and a full menstrual cycle during the drug-free period (previous users) or
3. directly switch from another hormonal contraceptive (switchers).
3. Only for subjects who were not pregnant and did not use hormonal contraception during the last 6 months before consent/assent:
Regular cycles (i.e. cycle length between 24 and 35 days) during the last 6 months.
Exclusion Criteria:
1. Pregnancy or wish of pregnancy.
2. Subject is known to or suspected of not being able to comply with the trial protocol, the use of the trial medication or the use of the trial diary.
3. History of infertility.
4. Known bleeding disorder or history of unexplained bleeding or bruising within the last 12 months prior to V1a.
5. Unexplained amenorrhoea.
6. Abnormal finding on pelvic, breast or ultrasound examination that in the investigator's opinion contraindicates participation in the trial.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
15 Years
Maximum Age:
45 Years
Study:
NCT06019533
Study Brief:
Protocol Section:
NCT06019533