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 @ 1:04 AM
Ignite Modification Date:
2025-12-25 @ 1:04 AM
NCT ID:
NCT01107093
Eligibility Criteria:
Inclusion Criteria:
* Women of good general health aged 18 - 35 years
* Not at risk of pregnancy
* Regular menstrual cycles of 24-35 days duration
* Not pregnant
* Intact uterus and ovaries
* Haemoglobin ≥ 11 g/dl
* Normal laboratory tests and normal TSH
* Willing to abstain from any use of hormonal contraception until study completion
* No current use of hormonal contraception and having had at least one complete menstrual cycle (2 menses) since termination of previous hormonal contraception
* Had at least one complete menstrual cycle (2 menses) following delivery, miscarriage or induced abortion
* Able to give voluntary, written informed consent, and agreeing to observe all study requirements for 5 complete menstrual cycles
Exclusion Criteria:
* Current participation in any other trial of an investigational medicine
* Known hypersensitivity to the ingredients of the test active substances or excipients
* Suspected hyperplasia or carcinoma of the endometrium
* Current pregnancy as confirmed by positive serum beta-hCG at screening
* Desire to get pregnant before the planned end of the study participation
* Currently breastfeeding
* Abnormal Pap smear
* Cancer (past history of any carcinoma or sarcoma)
* Known or suspected alcoholism or drug abuse
* Abnormal thyroid status
* Body mass index \> 32
* Current use of hormonal contraception
* Use of hormonal emergency contraception since last menstrual period
* Severe asthma insufficiently controlled by oral glucocorticoids
* Hereditary galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
35 Years
Study:
NCT01107093
Study Brief:
Protocol Section:
NCT01107093