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Phase 4
18 Years
40 Years
Open (Enrolling)
Female
Polycystic Ovary Syndrome

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Trial Information


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Principal Investigator

Marianne Andersen, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Odense University Hospital

Authority:

Denmark: National Board of Health

Study ID:

027

NCT ID:

NCT00451568

Start Date:

March 2007

Completion Date:

April 2010

Related Keywords:

  • Polycystic Ovary Syndrome
  • Polycystic ovary syndrome
  • Polycystic Ovary Syndrome

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