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 @ 2:42 AM
Ignite Modification Date:
2025-12-25 @ 2:42 AM
NCT ID:
NCT00647933
Eligibility Criteria:
Inclusion Criteria:
* Good physical and mental health;
* Body Mass Index between 18 and 29 kg/m\^2;
* Good venous accessibility;
Exclusion Criteria:
* Clinically relevant abnormal blood chemistry, hematology and/or urinalysis at screening;
* Hypertension (sitting diastolic blood pressure \> 90 mmHg and/or systolic blood pressure \> 150 mmHg);
* Contraindications for the use of oral contraceptives or gonadotropins;
* PAP-smear (= III) according to the Papanicolaou classification;
* History of endocrine abnormalities such as hyperprolactinaemia, polycystic ovary syndrome or any evidence of ovarian dysfunction;
* Primary ovarian failure;
* Ovarian cysts or enlarged ovaries, not related to polycystic ovarian disease;
* Any ovarian and/or abdominal abnormality that would interfere with adequate ultrasound investigation;
* Ovarian surgery;
* Smoking more than 10 cigarettes or equivalents a day;
* History (within 12 months) of alcohol or drugs abuse;
* Blood donation (\> 200 ml) within 90 days prior to screening;
* Administration of investigational drugs within 90 days prior to start Org 36286.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
38 Years
Study:
NCT00647933
Study Brief:
Protocol Section:
NCT00647933