Polycystic Ovary SyndromePhase 3FlowMetNCT00466622
Uterine Artery Blood Flow in Pregnant Women With PCOS Treated With Metformin
A Phase 3 study testing Metformin in people with Polycystic Ovary Syndrome, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2007to Feb 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Same as in the PregMet study
Trial locations and contacts
1 site in 1 country.
Norway1 site
Dept. of Obstetrics and Gynecology, National Center for fetal Medicine, University Hospital of Trondheim
Trondheim, 7006
About this study
Official title: Uterine Artery Blood Flow in Pregnant Women With Polycystic Ovary Syndrome(PCOS)Treated With Metformin - a Substudy to The PregMet Study
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.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Metformin, Placebo
- Keywords
- PCOS, pregnancy, metformin, blood flow, Pulsatility index
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called metformin 500mg tablets from Weifa
1000 mg x 2 daily. Orally. First tablet taken after the first Doppler examination and 3 hours before the next Doppler examination.
PlaceboDrug
Also called Placebo tablets from Weifa
Placebo 2 tablets x 2 daily. Orally from Weifa
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Metformin 1000mg x 2 daily. Orally. From Weifa Receives: Drug: Metformin |
| 2 | Placebo comparator | Placebo 2 tablets x 2 daily. Orally From Weifa Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulsatility index of the uterine artery
3 hrs before and after drug intake, 2 weeks after inclusion, and during medication
Measured: up to delivery
Secondary outcomes (1)
Blood flow in the umbilical artery and fetal cerebral artery
Measured: 24 weeks gestational
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2007 (estimated)
- Study startApr 2007
- Primary completionAug 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Eszter Vanky, MD, Phd, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00466622
- Sponsor's protocol ID
- 2004-000792-33
- Other IDs
- 2004
- Acronym
- FlowMet
- Status last verified
- Jul 2016
- First submitted
- 26 Apr 2007
- Last updated
- 20 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Stridsklev S, Carlsen SM, Salvesen O, Clemens I, Vanky E. Midpregnancy Doppler ultrasound of the uterine artery in metformin- versus placebo-treated PCOS women: a randomized trial. J Clin Endocrinol Metab. 2014 Mar;99(3):972-7. doi: 10.1210/jc.2013-3227. Epub 2014 Jan 1.
PubMed 24423336Stridsklev S, Salvesen O, Salvesen KA, Carlsen SM, Vanky E. Uterine Artery Doppler in Pregnancy: Women with PCOS Compared to Healthy Controls. Int J Endocrinol. 2018 Aug 16;2018:2604064. doi: 10.1155/2018/2604064. eCollection 2018.
PubMed 30186323
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uterine Artery Blood Flow in Pregnant Women With Polycystic Ovary Syndrome(PCOS)Treated With Metformin - a Substudy to The PregMet Study
- ClinicalTrials.gov ID
- NCT00466622
- Acronym / sponsor ID
- FlowMet / 2004-000792-33
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- PCOS, pregnancy, metformin, blood flow, Pulsatility index
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- Apr 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 27 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: MetforminMetformin 1000mg x 2 daily. Orally. From Weifa |
| 2 | Placebo comparator | Drug: PlaceboPlacebo 2 tablets x 2 daily. Orally From Weifa |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Same as in the PregMet study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetforminAlso: metformin 500mg tablets from Weifa1000 mg x 2 daily. Orally. First tablet taken after the first Doppler examination and 3 hours before the next Doppler examination. | Drug | 1 |
| PlaceboAlso: Placebo tablets from WeifaPlacebo 2 tablets x 2 daily. Orally from Weifa | Drug | 2 |
Primary outcome
Pulsatility index of the uterine artery
Time frame: up to delivery
3 hrs before and after drug intake, 2 weeks after inclusion, and during medication
1 secondary outcome
Blood flow in the umbilical artery and fetal cerebral artery
Time frame: 24 weeks gestational
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2016.
- Results publication: PubMed 24423336Stridsklev S, Carlsen SM, Salvesen O, Clemens I, Vanky E. Midpregnancy Doppler ultrasound of the uterine artery in metformin- versus placebo-treated PCOS women: a randomized trial. J Clin Endocrinol Metab. 2014 Mar;99(3):972-7. doi: 10.1210/jc.2013-3227. Epub 2014 Jan 1.
- Derived from this study: PubMed 30186323Stridsklev S, Salvesen O, Salvesen KA, Carlsen SM, Vanky E. Uterine Artery Doppler in Pregnancy: Women with PCOS Compared to Healthy Controls. Int J Endocrinol. 2018 Aug 16;2018:2604064. doi: 10.1155/2018/2604064. eCollection 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eszter Vanky, MD, Phd principal investigator
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Metformin in people with Polycystic Ovary Syndrome, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulsatility index of the uterine artery (time frame: up to delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00466622, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2016.