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:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2025-12-24 @ 9:15 PM
NCT ID:
NCT00005104
Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Patients with chronic anovulation due to polycystic ovary syndrome (PCOS) who have failed clomiphene citrate
Must have oligoovulation and hyperandrogenemia
--Prior/Concurrent Therapy--
Endocrine therapy: At least 2 months since prior clomiphene citrate
Other:
* At least 2 months since prior standard therapy (including over the counter drugs)
* At least 2 months since prior investigational drugs
* Prior multi/prenatal vitamins allowed
--Patient Characteristics--
Hematopoietic: Hematocrit greater than 38%
Hepatic:
* Liver function normal
* No clinically significant hepatic disease
Renal:
* No clinically significant renal disease
* Creatinine less than 1.4 mg/dL
* No proteinuria
Cardiovascular: No clinically significant cardiac disease
Pulmonary: No clinically significant pulmonary disease
Hormonal:
* Thyroid function normal
* Prolactin normal
* Estradiol normal
* Fasting 17 alpha-hydroxy progesterone less than 200 ng/dL OR No late onset adrenal hyperplasia 21 alpha-hydroxylase deficiency
Other:
* Not pregnant
* Negative pregnancy test
* Male partner must have a normal semen analysis by WHO criteria
* Must be in acceptable health by interview, medical history, physical exam, and laboratory tests
* No diabetes mellitus
* No clinically significant neurologic, psychiatric, infectious, neoplastic, or metabolic disease
* No clinically significant malignant disease except nonmelanomatous skin cancer
* At least 1 year since any prior drug abuse or alcoholism
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT00005104
Study Brief:
Protocol Section:
NCT00005104