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 @ 4:56 AM
Ignite Modification Date:
2025-12-25 @ 4:56 AM
NCT ID:
NCT01709318
Eligibility Criteria:
Inclusion Criteria:
* Body mass index (BMI) ≥18 and ≤35
* Regular cycles from 24 to 35 days in length, with an intra-individual variation of ±3 days permitted within this range
* Good physical and mental health
Exclusion Criteria:
* Diabetes mellitus with vascular involvement
* Presence of a severe or multiple risk factor(s) for venous or arterial thrombosis
* Severe dyslipoproteinemia
* Severe hypertension
* Presence or history of pancreatitis associated with severe hypertriglyceridaemia
* Presence or history of severe hepatic disease
* Undiagnosed vaginal bleeding
* Known or suspected pregnancy
* Participation in another investigational drug study within 30 days prior to screening visit
* History of malignancy ≤5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
* Documented abnormal cervical smear result in 6 months prior to screening visit
* Sterilization using a fallopian tube occlusion device (e.g., Essure method)
* Sex hormone therapy within 2 months prior to screening visit for purpose other than contraception, or injectable hormonal contraception within 6 months prior to screening
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
35 Years
Study:
NCT01709318
Study Brief:
Protocol Section:
NCT01709318