Metformin and Lifestyle Intervention in Women With Polycystic Ovary Syndrome

NCT00679679 | Completed Phase 4

• 1 other identifier: Fux-1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Polycystic Ovary Syndrome

Keywords

Polycystic ovary syndrome; Treatment; Metformin

Outcome Measures

Primary Outcomes (1)

• 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

  4 months

Study Arms (2)

Metformin

EXPERIMENTAL

Every patient will be given diet and exercise counseling in both arms. Intervention arm will receive metformin

Drug: Metformin

Placebo

PLACEBO COMPARATOR

Every patient will be given diet and exercise counseling in both arms. Intervention arm will receive metformin

Drug: Placebo

Interventions

Metformin DRUG

Metformin 750 mg BID for 4 months

Also known as: D.B.I. 500 mg. 1 1/2 tables BID

Metformin

Placebo DRUG

Diet counseling and exercise

Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Privado de Cordoba, Argentina: lead

Study Sites (1)

Hospital Privado de Córdoba

Córdoba, Córdoba Province, X5016KEH, Argentina

Location

Related Publications (38)

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• Fux Otta C, Wior M, Iraci GS, Kaplan R, Torres D, Gaido MI, Wyse EP. Clinical, metabolic, and endocrine parameters in response to metformin and lifestyle intervention in women with polycystic ovary syndrome: a randomized, double-blind, and placebo control trial. Gynecol Endocrinol. 2010 Mar;26(3):173-8. doi: 10.3109/09513590903215581.

  PMID: 20148739 DERIVED

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Metformin

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Carolina Fux Otta, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 15, 2008
• First Posted: May 19, 2008
• Study Start: January 1, 2003
• Primary Completion: September 1, 2005
• Study Completion: December 1, 2005
• Last Updated: May 19, 2008

Record last verified: 2008-05

Locations

AR (1)