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Uterine Artery Blood Flow in Pregnant Women With PCOS Treated With Metformin (FlowMet)

This study has been completed.
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00466622
First received: April 26, 2007
Last updated: November 16, 2011
Last verified: November 2011
History of Changes
  Purpose

FlowMet study is a "sub-study" of the PregMet study (registered in 2005).

The aim of the FlowMet study is to register the possible effect of metformin on the blood flow of the uterine artery in pregnant PCOS women. The participants will be examined with ultrasound Doppler in gestational week 10-13:

  1. before and 3h after the first tablet intake of metformin/placebo
  2. and 10-14 days after inclusion in the trial
  3. blood flow in the umbilical artery and fetal cerebral artery in gestational week 24.

Condition Intervention Phase
Polycystic Ovary Syndrome
 Drug: Metformin
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Uterine Artery Blood Flow in Pregnant Women With Polycystic Ovary Syndrome(PCOS)Treated With Metformin - a Substudy to The PregMet Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Pulsatility index of the uterine artery [ Time Frame: up to delivery ] [ Designated as safety issue: No ]
    3 hrs before and after drug intake, 2 weeks after inclusion, and during medication


Secondary Outcome Measures:
  • Blood flow in the umbilical artery and fetal cerebral artery [ Time Frame: 24 weeks gestational ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: April 2007
Study Completion Date: February 2010
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Metformin 1000mg x 2 daily. Orally. From Weifa
 Drug: Metformin
1000 mg x 2 daily. Orally. First tablet taken after the first Doppler examination and 3 hours before the next Doppler examination.
Other Name: metformin 500mg tablets from Weifa
Placebo Comparator: 2
Placebo 2 tablets x 2 daily. Orally From Weifa
 Drug: Placebo
Placebo 2 tablets x 2 daily. Orally from Weifa
Other Name: Placebo tablets from Weifa

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Same as in the PregMet study. As this study is a sub-study/extended study of the PregMet study, ONLY those included in the PregMet study (NCT00159536) can participate.

Exclusion Criteria:

  • Same as in the PregMet study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00466622

Locations
Norway
Dept. of Obstetrics and Gynecology, National Center for fetal Medicine, University Hospital of Trondheim
Trondheim, Norway, 7006
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Investigators
Principal Investigator: Eszter Vanky, MD, Phd Norwegian University of Science and Technology
  More Information

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00466622     History of Changes
Other Study ID Numbers: 2004-000792-33
Study First Received: April 26, 2007
Last Updated: November 16, 2011
Health Authority: Norway: Norwegian Medicines Agency
Norway: Norwegian Social Science Data Services

Keywords provided by Norwegian University of Science and Technology:
PCOS
pregnancy
metformin
blood flow
Pulsatility index

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
 Gonadal Disorders
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013