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Phase 4
16 Years
45 Years
Not Enrolling
Polycystic Ovary Syndrome

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Trial Information

Inclusion Criteria:

- All patients should have at least two of three following criteria: I) chronic
anovulation, II) clinical and/or biochemical evidence of androgen excess and III)
polycystic-appearing ovaries on transvaginal ultrasound.

Exclusion Criteria:

- Patients with Cushing's syndrome, hyperprolactinemia, diabetes mellitus (DM), thyroid
disease, adrenal hyperplasia and androgen-secreting tumors or other endocrinopathies,
will be excluded from the study.

- Patients with adrenal hyperplasia will be excluded by ACTH-stimulated
17-hydroxyprogesterone levels less than 10 ng/ml (15), and ACTH-stimulated
11-deoxycortisol levels less than 21 ng/ml [3-fold the 95th percentile (16) of a
historical control group of 60 healthy women controls].

- Those subjects who have kidney or liver diseases and those who were smoker or had
breast cancer will also be excluded from the study.

- None of the participants receive oral contraceptives (OCPs), steroid hormones or any
medications that interfere with lipid metabolism, ovarian and pituitary and
hypothalamic function, or insulin sensitivity in the last 3 months before study.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Serum total testosterone

Outcome Time Frame:

6 weeks

Safety Issue:



Iran: Ministry of Health

Study ID:

SUMS 84-258



Start Date:

January 2008

Completion Date:

November 2009

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