Metformin and Oral Contraceptives in PCOS

NCT00451568 | Completed Phase 4 DMC

• 1 other identifier: 027
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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. Inclusioncriteria:

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

Conditions

Polycystic Ovary Syndrome

Keywords

Polycystic ovary syndrome

Outcome Measures

Primary Outcomes (1)

• Changes in fasting insulin and area under the curve for insulin (2 hours)

  12 months

Secondary Outcomes (3)

• 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

  12 months

• Changes in cortisol metabolism

  12 months

• Changes in the prevalence of reactive hypoglycemia and areal under the curve for glucose (5 hours)

  12 months

Study Arms (3)

1

ACTIVE COMPARATOR

metformin

Drug: Metformin

2

ACTIVE COMPARATOR

desorelle

Drug: Desorelle

3

ACTIVE COMPARATOR

desorelle + metformin

Drug: Metformin; Drug: Desorelle

Interventions

Metformin DRUG

500 mg 2 tablets 2 times a day

1; 3

Desorelle DRUG

1 tablet/day in 21 days

2; 3

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Odense University Hospital

Odense, Denmark

Location

Related Publications (4)

• Glintborg D, Petersen MH, Ravn P, Hermann AP, Andersen M. Comparison of regional fat mass measurement by whole body DXA scans and anthropometric measures to predict insulin resistance in women with polycystic ovary syndrome and controls. Acta Obstet Gynecol Scand. 2016 Nov;95(11):1235-1243. doi: 10.1111/aogs.12964.

  PMID: 27529295 DERIVED

• Mumm H, Altinok ML, Henriksen JE, Ravn P, Glintborg D, Andersen M. Prevalence and possible mechanisms of reactive hypoglycemia in polycystic ovary syndrome. Hum Reprod. 2016 May;31(5):1105-12. doi: 10.1093/humrep/dew046. Epub 2016 Mar 23.

  PMID: 27008892 DERIVED

• Glintborg D, Mumm H, Altinok ML, Richelsen B, Bruun JM, Andersen M. Adiponectin, interleukin-6, monocyte chemoattractant protein-1, and regional fat mass during 12-month randomized treatment with metformin and/or oral contraceptives in polycystic ovary syndrome. J Endocrinol Invest. 2014 Aug;37(8):757-764. doi: 10.1007/s40618-014-0103-8. Epub 2014 Jun 7.

  PMID: 24906976 DERIVED

• Glintborg D, Altinok ML, Mumm H, Hermann AP, Ravn P, Andersen M. Body composition is improved during 12 months' treatment with metformin alone or combined with oral contraceptives compared with treatment with oral contraceptives in polycystic ovary syndrome. J Clin Endocrinol Metab. 2014 Jul;99(7):2584-91. doi: 10.1210/jc.2014-1135. Epub 2014 Apr 17.

  PMID: 24742124 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

• Marianne Andersen, MD, PhD

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 22, 2007
• First Posted: March 23, 2007
• Study Start: March 1, 2007
• Primary Completion: January 1, 2012
• Study Completion: April 1, 2013
• Last Updated: April 13, 2015

Record last verified: 2015-04

Locations

DK (1)