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

December 26, 2013 updated by: Qifu Li, Chongqing Medical University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400016
        • The First Affiliated Hospital of Chongqing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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 Names:
  • Glucophage
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.
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 Names:
  • Diane-35

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the efficacy of Metformin and Diane-35
Time Frame: at 12 weeks
Ovulation,Menstrual cycle,Insulin sensitivity
at 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes of adipokine（PEDF,GPRN，etc）levels from baseline
Time Frame: at 12 weeks
changes of adipokine（PEDF,GPRN，etc）levels from baseline
at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chongqing Medical University

Investigators

  • Principal Investigator: Qifu Li, PhD, First Affiliated Hospital of Chongqing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

April 5, 2012

First Submitted That Met QC Criteria

April 6, 2012

First Posted (Estimate)

April 9, 2012

Study Record Updates

Last Update Posted (Estimate)

December 30, 2013

Last Update Submitted That Met QC Criteria

December 26, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCOS-Qifu Li

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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