Metformin and Oral Contraceptives in PCOS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00451568
Recruitment Status : Completed
First Posted : March 23, 2007
Last Update Posted : April 13, 2015
Information provided by (Responsible Party):
Marianne Andersen, Odense University Hospital

Brief Summary:

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.


  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.


Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Drug: Metformin Drug: Desorelle Phase 4

Detailed Description:

90 patients are included and randomized to 12 months of treatment with metformin (1000+1000 mg/d) or OCP (150 mg desogestrel 30 microgram ethinylestradiol) or combined treatment (metformin+OCP).

Patients attend a biochemical and physical examination at study inclusion and at 12 months. Patients attend for registration of side effects and compliance after 6 months of study duration. Safety tests are performed at all three visits and include weight, blood pressure, HbA1c, liver enzymes, electrolytes, and white blood cell count. Pregnancy tests are performed by the participants each month. Patients are given general advice on lifestyle intervention. Patients are excluded if they initiated medical treatment with possible hormonal and metabolic effects during the intervention period. Lifestyle intervention is allowed. Laser treatment is offered to patients with moderate or severe facial hirsutism and patients are allowed to shave/wax. The patients accept not applying cosmetic treatment 3-4 days before attending for evaluation at the clinic.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Metformin and Oral Contraceptives in PCOS
Study Start Date : March 2007
Actual Primary Completion Date : January 2012
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Drug: Metformin
500 mg 2 tablets 2 times a day
Active Comparator: 2
Drug: Desorelle
1 tablet/day in 21 days
Active Comparator: 3
desorelle + metformin
Drug: Metformin
500 mg 2 tablets 2 times a day
Drug: Desorelle
1 tablet/day in 21 days

Primary Outcome Measures :
  1. Changes in fasting insulin and area under the curve for insulin (2 hours) [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Changes in BMD, 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 [ Time Frame: 12 months ]
  2. Changes in cortisol metabolism [ Time Frame: 12 months ]
  3. Changes in the prevalence of reactive hypoglycemia and areal under the curve for glucose (5 hours) [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00451568

Odense University Hospital
Odense, Denmark
Sponsors and Collaborators
Odense University Hospital
Principal Investigator: Marianne Andersen, MD, PhD Odense University Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Marianne Andersen, Professor, Odense University Hospital Identifier: NCT00451568     History of Changes
Other Study ID Numbers: 027
First Posted: March 23, 2007    Key Record Dates
Last Update Posted: April 13, 2015
Last Verified: April 2015

Keywords provided by Marianne Andersen, Odense University Hospital:
Polycystic ovary syndrome

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Contraceptive Agents
Contraceptives, Oral
Hypoglycemic Agents
Physiological Effects of Drugs
Reproductive Control Agents
Contraceptive Agents, Female