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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Qifu Li, Chongqing Medical University
ClinicalTrials.gov Identifier:
NCT01573377
First received: April 5, 2012
Last updated: December 26, 2013
Last verified: December 2013

April 5, 2012
December 26, 2013
February 2012
February 2013   (final data collection date for primary outcome measure)
the efficacy of Metformin and Diane-35 [ Time Frame: at 12 weeks ] [ Designated as safety issue: No ]
Ovulation,Menstrual cycle,Insulin sensitivity
Same as current
Complete list of historical versions of study NCT01573377 on ClinicalTrials.gov Archive Site
changes of adipokine(PEDF,GPRN,etc)levels from baseline [ Time Frame: at 12 weeks ] [ Designated as safety issue: No ]
changes of adipokine(PEDF,GPRN,etc)levels from baseline
Same as current
Not Provided
Not Provided
 
Efficacy of Metformin and Diane-35 on PCOS Patients,a Randomized, Controlled, Prospective Clinical Trial
Efficacy of Metformin and Diane-35 on PCOS Patients,a Randomized, Controlled, Prospective Clinical Trial

Polycystic ovary syndrome (PCOS) is one of the most common endocrinopathies in reproductive-age women, and it affects 5-7% of this group. It is characterized by disturbed menstrual cycle, ovulatory dysfunction and hyperandrogenism. Over 40% of PCOS women might become the patients with impaired glucose tolerance or type 2 diabetes. It has been confirmed that insulin resistance (IR) is a common feature in PCOS and adipokines might play roles in the pathogenesis of IR and PCOS, because these adipokines have wide-ranging effects on carbohydrate and lipid metabolism.

The present clinical trial intends to compare the effects of metformin and oral contraceptives on PCOS patients, focusing on the insulin sensitivity, ovulation, and menstrual cycle etc. The investigators also aim to study the effects of metformin on serum adipokine levels(such as pigment epithelium-derived factor, progranulin etc.)in PCOS patients.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Polycystic Ovary Syndrome
  • Insulin Resistance
  • Drug: Metformin
    425mg bid for morning and evening after meals, one week after treatment, increase the dosage to 850 mg bid. If the patients have side effects such as nausea, diarrhea and other gastrointestinal symptoms, the dose would be reduced to 425mg bid for 1 week, and try the dosage to 425mg tid again, until the maximum tolerated dose.
    Other Name: Glucophage
  • Drug: Ethinylestradiol and Cyproterone Acetate
    from the first day of bleeding of the menstrual cycle, daily oral administration of one pill for 21 days consecutively, then stopped taking the pill for seven days, and on the eighth day to start taking the pill again.
    Other Name: Diane-35
  • Experimental: metformin
    425mg bid for morning and evening after meals, one week after treatment, increase the dosage to 850 mg bid. If the patients have side effects such as nausea, diarrhea and other gastrointestinal symptoms, the dose would be reduced to 425mg bid for 1 week, and try the dosage to 425mg tid again, until the maximum tolerated dose.
    Intervention: Drug: Metformin
  • Experimental: Ethinylestradiol and Cyproterone Acetate
    From the first day of the menstruation, oral administration of one pill daily for 21 days consecutively, then discontinue using the pill for seven days, and on the eighth day, restart taking the pill.
    Intervention: Drug: Ethinylestradiol and Cyproterone Acetate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
February 2013
February 2013   (final data collection date for primary outcome measure)

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

Female
18 Years to 35 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01573377
PCOS-Qifu Li
Yes
Qifu Li, Chongqing Medical University
Chongqing Medical University
Not Provided
Principal Investigator: Qifu Li, PhD First Affiliated Hospital of Chongqing Medical University
Chongqing Medical University
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP