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Metformin and Oral Contraceptives in PCOS

This study has been completed.
Information provided by (Responsible Party):
Marianne Andersen, Odense University Hospital Identifier:
First received: March 22, 2007
Last updated: April 10, 2015
Last verified: April 2015

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 Intervention Phase
Polycystic Ovary Syndrome
Drug: Metformin
Drug: Desorelle
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Metformin and Oral Contraceptives in PCOS

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) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Changes in cortisol metabolism [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Changes in the prevalence of reactive hypoglycemia and areal under the curve for glucose (5 hours) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: March 2007
Study Completion Date: April 2013
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Genders 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
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Please refer to this study by its identifier: NCT00451568

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

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 
Study First Received: March 22, 2007
Last Updated: April 10, 2015
Health Authority: Denmark: National Board of Health

Keywords provided by 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 processed this record on October 21, 2016