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 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT01103518
Eligibility Criteria:
Inclusion Criteria:
* Female subject
* Premenopausal subject
* 18 years or older
* Medical history of irregular menses lasting at least 3 months
* Signature of informed consent
Exclusion Criteria:
* Pregnancy
* Use of hormonal contraceptives within 3 months of screening
* Primary bilateral oophorectomy
* Chemotherapy and / or radiotherapy within 6 months of screening
* Hysterectomy
* Myotonic dystrophy
* Galactosemia
* Galactorrhea
* History of tuberculosis or schistosomiasis
* Elevated prolactin / other significant laboratory alterations
* Diabetes
* Premature ovarian deficiency
* Sensitivity to any component of the drug formula
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01103518
Study Brief:
Protocol Section:
NCT01103518