Metformin and Lifestyle Intervention in Women With Polycystic Ovary Syndrome

This study has been completed.
Sponsor:
Information provided by:
Hospital Privado de Cordoba, Argentina
ClinicalTrials.gov Identifier:
NCT00679679
First received: May 15, 2008
Last updated: May 16, 2008
Last verified: May 2008
  Purpose

Polycystic ovary syndrome is a frequent cause of abnormal menses and infertility. It has also been related to cardiovascular disease.

The objective of this trial is to evaluate the clinical and metabolic efficacy of metformin plus life style modifications in women with polycystic ovary syndrome compared with life style modifications and placebo


Condition Intervention Phase
Polycystic Ovary Syndrome
Drug: Metformin
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Metabolic and Endocrine Parameters in Response to Metformin and Lifestyle Intervention in Women With Polycystic Ovary Syndrome: A Phase 4 Randomized, Double- Blind and Placebo Control Trial

Resource links provided by NLM:


Further study details as provided by Hospital Privado de Cordoba, Argentina:

Primary Outcome Measures:
  • Body mass index,Normalization of menses,Pregnancy,Hirsutism,Waist to hip ratio, Testosterone, Androstenedione, DHEAS,Progesterone, FSH, LH,Glucose, OGTT,Insulinemia,Total HDL and LDL Cholesterol, Triglycerides,Uric acid, Prostate specific antigen [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: January 2003
Study Completion Date: December 2005
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Metformin
Every patient will be given diet and exercise counseling in both arms. Intervention arm will receive metformin
Drug: Metformin
Metformin 750 mg BID for 4 months
Other Name: D.B.I. 500 mg. 1 1/2 tables BID
Placebo Comparator: Placebo
Every patient will be given diet and exercise counseling in both arms. Intervention arm will receive metformin
Drug: Placebo
Diet counseling and exercise

Detailed Description:

Polycystic ovary syndrome (PCOS) is a common and heterogeneous disorder of women in reproductive age. It is characterized by hyperandrogenism and chronic anovulation. Several studies in diverse populations estimate it's prevalence at 5-10%. Women present, in a high percentage of cases, with obesity, hirsutism, acne, menstrual irregularities and infertility. Although the exact physiopathology of PCOS remains unknown, several studies tend to point to insulinoresistance (IR) as the cause of the syndrome. IR is present in 60 to 70% of patients independently of obesity. Compensatory hyperinsulinism has a pivotal role in the physiopathogenesis of PCOS. In vitro, insulin stimulates androgen synthesis in thecal cells and decrease sex hormone-binding globulin synthesis in the liver, increasing free androgen availability.

Due to the high prevalence of IR, PCOS shares components of metabolic syndrome: abdominal obesity, impaired glucose tolerance, gestational and type 2 diabetes, abnormalities in lipid profile, blood hypertension, endothelial dysfunction and probably cardiovascular disease.

In the past, PCOS treatment was focus on ovulation induction for infertility, oral contraceptives for irregular bleeding, and androgens antagonists for hirsutism or acne. In later years insulin sensitizing agents have been used to reduce hyperinsulinemia, improve ovary function and associated metabolic abnormalities. Metformin (MTF), a biguanide, usually used in obese patients with type 2 diabetes,inhibits glucose hepatic production,decreases insulin secretion and increases peripheral insulin sensitivity.

Some studies have reported an improvement in insulin sensitivity associated with reduction of hyperandrogenism and improvements in reproductive abnormalities with MTF. On the other hand, other authors failed to observe those changes. However, an off label indication for it usage in PCOS for FDA and the lack of large controlled trials, MTF indication to treat PCOS has grown dramatically in later years.

In obese women with PCOS, weight loss effectively ameliorates hyperandrogenism and metabolic disorders by improving insulin resistance.

Some trials have suggested that those effects could be improved with insulin sensitizing agents without changes in body weigh.

The present study was designed to assess, in a randomized, double-blind, placebo-controlled way, the effects of MTF in addition to lifestyle modifications on endocrine and metabolic disturbances in women with PCOS.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women in reproductive age
  • With polycystic ovary syndrome defined by hyperandrogenism (elevated serum testosterone concentrations), and oligomenorrhea (cycles of 35 days or longer), or amenorrhea (no menses in the last 6 months) after negative screening pregnancy test

Exclusion Criteria:

  • Pregnancy
  • Cushing' s syndrome
  • Late onset congenital adrenal hyperplasia
  • Androgen-secreting tumors
  • Uncontrolled thyroid disease
  • Hyperprolactinemia
  • Diabetes any
  • Cardiovascular diseases (Ischaemic heart disease, uncontrolled hypertension, heart failure)
  • Acute or chronic infections at baseline
  • Renal disease
  • Liver disease
  • Had taken any medications for at least 3 months before enrolment in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00679679

Locations
Argentina
Hospital Privado de Córdoba
Cordoba, Argentina, X5016KEH
Sponsors and Collaborators
Hospital Privado de Cordoba, Argentina
Investigators
Principal Investigator: Carolina Fux Otta, MD
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Carolina Fux Otta, Hospital Privado de Córdoba, Argentina
ClinicalTrials.gov Identifier: NCT00679679     History of Changes
Other Study ID Numbers: Fux-1
Study First Received: May 15, 2008
Last Updated: May 16, 2008
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by Hospital Privado de Cordoba, Argentina:
Polycystic ovary syndrome
Treatment
Metformin

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Disease
Pathologic Processes
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014