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Efficacy of Metformin and Diane-35 on PCOS Patients,a Randomized, Controlled, Prospective Clinical Trial


N/A
18 Years
35 Years
Open (Enrolling)
Female
Polycystic Ovary Syndrome, Insulin Resistance

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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

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