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Metformin and Oral Contraceptives in PCOS
This study is currently recruiting participants.
Verified by Odense University Hospital, March 2007
First Received: March 22, 2007   No Changes Posted
Sponsored by: Odense University Hospital
Information provided by: Odense University Hospital
ClinicalTrials.gov Identifier: NCT00451568
  Purpose

Background: PCOS is a common condition with a prevalence of 5-8 % in premenopausal women. More than 50% of PCOS patients are insulin resistant and have a diabetes risk 5-8 times higher than age- and weight-matched controls. Studies using insulin sensitizers in PCOS found increased insulin sensitivity and decreased insulin levels to be followed by decreased androgen levels and improved ovulatory function. No studies however, evaluated the long term effects of insulin sensitizing treatment. Oral contraceptives normalize menstrual cycles and suppress androgen levels in PCOS, however no long-term studies evaluated the effects of combined treatment with metformin and oral contraceptives in PCOS. Design: Randomized open study in 3*30 PCOS patients. Patients are randomised to 24 months of treatment with 1: metformin, 2: metformin and oral contraceptives or 3: oral contraceptives. Primary outcome measures: fasting insulin, AUC insulin. Secundary endpoints: BMI, WHR, LH, FSH, total and free-testosterone, c-peptid, urinary cortisol, AUC for insulin, glucose and c-peptid during OGTT.

Inclusioncriteria:

  1. Irregular menses or anovulaty cycles
  2. High free testosterone > 0,035 nmol/l or hirsutism
  3. PCO in vaginal US Criteria 1 and 2 OR 2 and 3.

Design:


Condition Intervention Phase
Polycystic Ovary Syndrome
Drug: Metformin
Drug: Yasmin
Phase IV

Drug Information available for: Metformin Metformin hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • Changes in fasting insulin and area under the curve for insulin (2 hours)

Secondary Outcome Measures:
  • Changes in BMI, WHR, LH, FSH, total and free testosterone, fasting blood glucose, fasting C-peptide, urine-cortisol secretion, body composition, number of hypoglycaemic cases, AUC for insulin, glucose and C-peptide during OGTT (2 and 5 ho

Estimated Enrollment: 90
Study Start Date: March 2007
Estimated Study Completion Date: April 2010
  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Irregular menses or anovulaty cycles
  • High free testosterone > 0.035 nmol/l or hirsutism
  • PCO in vaginal US Criteria 1 and 2 OR 2 and 3

Exclusion Criteria:

  • Age > 18 years
  • Postmenopausal
  • Diagnosis diabetes mellitus
  • Use of medicine known to affect hormones measured in the project
  • Pregnancy or planned pregnancy during study period
  • Non-Caucasian
  • Previous tromboembolic disease
  • Heavy smoker > 35 years and BMI > 35 kg/m2
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00451568

Contacts
Contact: Dorte Glintborg, MD, PhD +45 6541 1769 dorte.glintborg@dadlnet.dk
Contact: Marianne Andersen, MD, PhD +45 6541 1769 marianne.andersen@ouh.regionsyddanmark.dk

Locations
Denmark
Odense University Hospital Recruiting
Odense, Denmark
Contact: Dorte Glintborg, MD, PhD     +45 6541 1769     dorte.glintborg@dadlnet.dk    
Contact: Marianne Andersen, MD, PhD     +45 6541 1769     marianne.andersen@ouh.regionsyddanmark.dk    
Sponsors and Collaborators
Odense University Hospital
Investigators
Principal Investigator: Marianne Andersen, MD, PhD Odense University Hospital
  More Information

No publications provided

Study ID Numbers: 027
Study First Received: March 22, 2007
Last Updated: March 22, 2007
ClinicalTrials.gov Identifier: NCT00451568     History of Changes
Health Authority: Denmark: National Board of Health

Keywords provided by Odense University Hospital:
Polycystic ovary syndrome

Study placed in the following topic categories:
Gonadal Disorders
Contraceptive Agents
Contraceptives, Oral
Metformin
Contraceptive Agents, Female
Endocrine System Diseases
Ovarian Diseases
Cysts
Polycystic Ovarian Syndrome
Genital Diseases, Female
Hypoglycemic Agents
Polycystic Ovary Syndrome
Endocrinopathy
Ovarian Cysts

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

ClinicalTrials.gov processed this record on May 07, 2009