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

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

ChemIDplus related topics:

Metformin Metformin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Official Title:	Uterine Artery Blood Flow in Pregnant Women With Polycystic Ovary Syndrome(PCOS)Treated With Metformin - a Substudy to The PregMet Study

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 ]

Estimated Enrollment:	60
Study Start Date:	April 2007
Estimated Study Completion Date:	August 2009
Estimated 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

Contacts


Contact: Eszter Vanky, MD, PhD	+47 72573819	eszter.vanky@ntnu.no

Contact: Sven Magnus Carlsen, MD, PhD	+47 73868567	sven.carlsen@ntnu.no

Locations


Norway
	Dept. of Obstetrics and Gynecology, National Center for fetal Medicine, University Hospital of Trondheim	Recruiting
	Trondheim, Norway, 7006
	Contact: Solhild Stridsklev, MD +47 72571817 solhild.stridsklev@stolav.no
	Contact: Eszter Vanky, MD, PhD +47 72573819 eszter.vanky@ntnu.no
	Principal Investigator: Eszter Vanky, MD, PhD

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

Responsible Party:	Norwegian University of Science and Technology, St.Olavs Hospital ( Eszter Vanky and Solhild Stridsklev )
Study ID Numbers:	2004-000792-33
First Received:	April 26, 2007
Last Updated:	May 15, 2008
ClinicalTrials.gov Identifier:	NCT00466622
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

Study placed in the following topic categories:

Genital Diseases, Female

Gonadal Disorders

Metformin

Polycystic Ovary Syndrome

Endocrine System Diseases

Endocrinopathy

Ovarian Diseases

Cysts

Ovarian Cysts

Additional relevant MeSH terms:

Neoplasms

Hypoglycemic Agents

Pathologic Processes

Disease

Syndrome

Physiological Effects of Drugs

Pharmacologic Actions

Adnexal Diseases

ClinicalTrials.gov processed this record on September 05, 2008

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