Uterine Artery Blood Flow in Pregnant Women With PCOS Treated With Metformin - Full Text View

Sponsor:	Norwegian University of Science and Technology
Collaborator:	St. Olavs Hospital
Information provided by:	Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:	NCT00466622

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:

before and 3h after the first tablet intake of metformin/placebo
and 10-14 days after inclusion in the trial
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 III

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Placebo Control 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:

Drug Information available for: Metformin Metformin hydrochloride

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 before and 3h after first medicine intake [ Time Frame: 2009 ] [ Designated as safety issue: No ]
Pulsatility index of the uterine artery 10-14 days after inclusion, and ongoing medication [ Time Frame: 2009 ] [ Designated as safety issue: No ]
Blood flow in the umbilical artery and fetal cerebral artery at gestational week 24 [ Time Frame: 2009 ] [ 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
1: Experimental 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.
2: Placebo Comparator Placebo 2 tablets x 2 daily. Orally From Weifa	Drug: Placebo Placebo 2 tablets x 2 daily. Orally 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, St.Olavs Hospital ( Eszter Vanky and Solhild Stridsklev )
Study ID Numbers:	2004-000792-33
Study First Received:	April 26, 2007
Last Updated:	March 16, 2010
ClinicalTrials.gov Identifier:	NCT00466622 History of Changes
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:

Gonadal Disorders
Metformin
Physiological Effects of Drugs
Endocrine System Diseases
Ovarian Diseases
Cysts
Pharmacologic Actions

Adnexal Diseases
Genital Diseases, Female
Neoplasms
Hypoglycemic Agents
Polycystic Ovary Syndrome
Ovarian Cysts

ClinicalTrials.gov processed this record on March 18, 2010