Polycystic Ovary SyndromeNCT00317928
Efficacy of Metformin in PCOS: Metabolic and Hormonal Factors
A study testing Metformin in people with Polycystic Ovary Syndrome, run by Aarhus University Hospital Skejby.
Trial summary
Hypothesis: Metformin treatment normalises hormone values and metabolic parameters in women with PCOS. Ovulation is restored and bleeding periods become regular. Fifty women with PCOS (Rotterdam criteria) are randomised to either placebo or metformin for 6 months. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Metformin
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Aug 2001to Sep 2004
- Phase
- Interventional
- 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 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of PCOS
- Age 20 - 45
Who cannot join
- Diabetes
- Hormonal treatment
- Pregnancy, lactation
- Periclimacteric
About this study
Hypothesis: Metformin treatment normalises hormone values and metabolic parameters in women with PCOS. Ovulation is restored and bleeding periods become regular.
Fifty women with PCOS (Rotterdam criteria) are randomised to either placebo or metformin for 6 months. After a wash-out period of 3 months, the opposite treatment is given for another 6 months. Measurements are performed before ech treatment period, every second month during treatment and after completing treatment.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Metformin
- Keywords
- Polycystic Ovary Syndrome, Metformin, Metabolic Syndrome, Hyperandrogenism, Ovulation
- Medical subject headings
- Polycystic Ovary Syndrome, Metabolic Syndrome, Hyperandrogenism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2006 (estimated)
- Study startAug 2001
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital Skejby
- Sponsor type
- University, hospital or other
- Collaborators
- Regional Hospital Holstebro, Aarhus University Hospital
- Investigators
- Ditte Trolle, MD, Principal investigator, Skejby University Hospital, Aarhus, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00317928
- Sponsor's protocol ID
- 160350-1
- Status last verified
- Aug 2001
- First submitted
- 24 Apr 2006
- Last updated
- 11 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Metformin in PCOS: Metabolic and Hormonal Factors
- ClinicalTrials.gov ID
- NCT00317928
- Acronym / sponsor ID
- 160350-1
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- Polycystic Ovary Syndrome, Metformin, Metabolic Syndrome, Hyperandrogenism, Ovulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants
- Lead sponsor
- Aarhus University Hospital SkejbyUniversity, hospital or other
- Collaborators
- Regional Hospital Holstebro, Aarhus University Hospital
- Study start
- Aug 2001
- Study completion
- Sep 2004
- First posted
- 25 Apr 2006 (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.
Hypothesis: Metformin treatment normalises hormone values and metabolic parameters in women with PCOS. Ovulation is restored and bleeding periods become regular.
Fifty women with PCOS (Rotterdam criteria) are randomised to either placebo or metformin for 6 months. After a wash-out period of 3 months, the opposite treatment is given for another 6 months. Measurements are performed before ech treatment period, every second month during treatment and after completing treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Diagnosis of PCOS
- Age 20 - 45
Key exclusion criteria (4 listed)
- Diabetes
- Hormonal treatment
- Pregnancy, lactation
- Periclimacteric
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 |
|---|---|---|
| Metformin | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2006.
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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.
Ditte Trolle, MD principal investigator
Skejby University Hospital, Aarhus, Denmark
Questions about this trial
What is this clinical trial studying?
A study testing Metformin in people with Polycystic Ovary Syndrome, run by Aarhus University Hospital Skejby.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 11 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
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.
Where can I read the original study information?
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 11 Oct 2006.