Metformin and Oral Contraceptives in PCOS

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by Odense University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT00451568
First received: March 22, 2007
Last updated: NA
Last verified: March 2007
History: No changes posted
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


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
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: 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 by Odense University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00451568     History of Changes
Other Study ID Numbers: 027
Study First Received: March 22, 2007
Last Updated: March 22, 2007
Health Authority: Denmark: National Board of Health

Keywords provided by Odense University Hospital:
Polycystic ovary syndrome

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

ClinicalTrials.gov processed this record on September 18, 2014