Metformin and Oral Contraceptives in PCOS
Information source: Odense University Hospital
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Polycystic Ovary Syndrome
Intervention: Metformin (Drug); Yasmin (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Odense University Hospital Official(s) and/or principal investigator(s):
Marianne Andersen, MD, PhD, Principal Investigator, Affiliation: Odense University Hospital
Overall contact:
Dorte Glintborg, MD, PhD, Phone: +45 6541 1769, Email: dorte.glintborg@dadlnet.dk
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. 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:
Clinical Details
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Changes in fasting insulin and area under the curve for insulin (2 hours)
Secondary outcome: 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
Eligibility
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Female.
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
Locations and Contacts
Dorte Glintborg, MD, PhD, Phone: +45 6541 1769, Email: dorte.glintborg@dadlnet.dk
Odense University Hospital, Odense, Denmark; Recruiting
Dorte Glintborg, MD, PhD, Phone: +45 6541 1769, Email: dorte.glintborg@dadlnet.dk
Marianne Andersen, MD, PhD, Phone: +45 6541 1769, Email: marianne.andersen@ouh.regionsyddanmark.dk
Additional Information
Starting date: March 2007
Ending date: April 2010
Last updated: March 22, 2007
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