PregMet 2 study

Phase 1

Conditions: Poly Cystic Ovarial Syndrome (PCOS) in pregnant women. PCOS should be diagnosed according to the Rotterdam Consensus criterias:- at least 2 out of 3 criterias1.PCO in at least one ovary2.Oligo-/anovulation (clinically diagnosed as oligo-/amenorrhea,i.e. menstrual cycles > 35 days or <10 menstruations/year3.Hyperandrogenism
clinical or biochemical
MedDRA version: 14.1Level: LLTClassification code 10065161Term: Polycystic ovarian syndromeSystem Organ Class: 100000004872
Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

Registration Number: EUCTR2011-002203-15-IS

Lead Sponsor: TNU, Norwegian University of Science and Technology

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 1000

Inclusion Criteria

Inclusion criteria
•Age: 18-45 years
•PCOS diagnosed or reconfirmed according to Rotterdam 2003 criteria, not more than 5 years prior to inclusion.
•Mode of conception: Any
•Single, viable fetus, diagnosed by vaginal ultrasound
•Gestational week at inclusion: week 6 + 0 to 12 + 0.
•Wash out for metformin: at least 7 days
•Able to communicate fluently in the official language at the study cite or English
•Informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1000
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion criteria
•Any type of diabetes (except GDM in former pregnancy).
•Known liver disease or ALAT > 100 IU/L
•Known kidney disease or creatinine > 110 µmol/L
•Known alcohol or drug abuse
•Use of drugs interfering with metformin: erytromycin (or other macrolides), cimetidin, anticoagulation therapy
•Unsuitable for participation of other reasons
• Participating in other medical trials in the same period of time