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Metformin Treatment of Pregnant Women With Polycystic Ovary Syndrome (PCOS)


Phase 3
18 Years
45 Years
Not Enrolling
Female
Polycystic Ovary Syndrome

Thank you

Trial Information

Metformin Treatment of Pregnant Women With Polycystic Ovary Syndrome (PCOS)


Inclusion Criteria:



- 18-45 years,

- PCOS diagnosis according to Rotterdam criteria

- single, viable, ultrasound verified fetus

- if metformin was used at conception and early pregnancy, at least 7 days of "wash
out"

Exclusion Criteria:

- known liver disease or ALAT > 90 nmol/L

- known renal disease or creatinine > 110 micromol/L

- diabetes mellitus

- alcohol or drug abuse

- peroral steroid treatment

- cimetidine, anticoagulant or erythromycin treatment at time of inclusion

- not suitable for other reasons

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Gestational diabetes

Outcome Time Frame:

up to delivery

Safety Issue:

No

Principal Investigator

Eszter I Vanky, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Norwegian University of Science and Technology

Authority:

Norway: Norwegian Medicines Agency

Study ID:

PregMet

NCT ID:

NCT00159536

Start Date:

February 2005

Completion Date:

October 2009

Related Keywords:

  • Polycystic Ovary Syndrome
  • PCOS
  • metformin
  • pregnancy
  • preeclampsia
  • diabetes
  • preterm delivery
  • Polycystic Ovary Syndrome

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