Trial Information
Efficacy of Metformin and Diane-35 on PCOS Patients,a Randomized, Controlled, Prospective Clinical Trial
Inclusion Criteria:
with at least two of the following features : (i) oligo-amenorrhea or chronic anovulation;
(ii) clinical and/or biochemical hyperandrogenism; (iii) ultrasound appearance of
polycystic ovaries
Exclusion Criteria:
- other known causes of hyperandrogenemia and ovulatory dysfunction, including
21-hydroxylase deficiency, congenital adrenal hyperplasia, Cushing's syndrome,
androgen-secreting tumors, thyroid disease, and hyperprolactinemia.
use of hormone medications (including oral contraceptives) within the past month and the
use of medicines that affect insulin sensitivity (e.g., metformin or thiazolidinediones)
within the past three months
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
the efficacy of Metformin and Diane-35
Outcome Description:
Ovulation,Menstrual cycle,Insulin sensitivity
Outcome Time Frame:
at 12 weeks
Safety Issue:
No
Principal Investigator
Qifu Li, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
The First Affiliated Hospital of Chongqing Medical University
Authority:
China: Food and Drug Administration
Study ID:
PCOS-Qifu Li
NCT ID:
NCT01573377
Start Date:
February 2012
Completion Date:
January 2013
Related Keywords:
- Polycystic Ovary Syndrome
- Insulin Resistance
- polycystic ovary syndrome
- insulin resistance
- Insulin Resistance
- Polycystic Ovary Syndrome