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 @ 2:03 AM
Ignite Modification Date:
2025-12-25 @ 2:03 AM
NCT ID:
NCT01802060
Eligibility Criteria:
Inclusion Criteria:
* Female
* Aged 18 - 40 years
* Menstrual cycle length between 23 and 35 days
* Had two natural cycles prior to study participation
* Using non-hormonal contraception to avoid pregnancy OR abstaining from intercourse for the last three months and the present cycle
N.B: Non hormonal contraception includes barrier methods such as male and female condoms, diaphragms or caps, non-hormonal intra-uterine devices such as coils, male and female sterilisation or natural family planning
Exclusion Criteria:
* Unwilling to provide written informed consent to participate in the study or comply with study procedures
* Pregnant
* Breastfeeding
* Has menopausal symptoms such as night sweats or hot flushes
* Using any hormonal treatments e.g. hormonal contraception, fertility treatments and hormone replacement therapy (except thyroxin)
* Taking antibiotics (based on decision by principle investigator)
* Has a diagnosis of polycystic ovarian syndrome (PCOS)
* Has impaired liver or kidney function
* Intending to use PERSONA as a contraceptive during the study period
* Contraindications to frequent blood sampling e.g. anaemia, hypotonia and blood clotting diseases
* Contraindications to frequent ultrasound examinations e.g. morbid obesity and recent abdominal surgery
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT01802060
Study Brief:
Protocol Section:
NCT01802060