Polycystic Ovary SyndromePhase 4NCT00437333
Metformin Suspension and Insulin Sensitivity
A Phase 4 study testing Metformin cloridrate in people with Polycystic Ovary Syndrome, run by University Magna Graecia at 1 site in Italy.
Trial summary
Metformin is an insulin sensitizing drug routinely used for the treatment of anovulatory patients with polycystic ovary syndrome (PCOS). To date, the metabolic effects of the long-term metformin administration are know but no data are available on the effects after its suspension. Read more about this study
- Who is it for?
- Ages 20 to 30 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Metformin cloridrate
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2003to Apr 2006
- Phase
- Phase 4
- 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 30 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Polycystic ovary syndrome (using NIH criteria).
Who cannot join
- Age <20 or >30 years;
- BMI higher than 25 and lower than 18;
- Neoplastic, metabolic, hepatic, and cardiovascular disorders or other concurrent medical illnesses;
- Hypothyroidism, hyperprolactinemia, Cushing's syndrome, and non-classical congenital adrenal hyperplasia;
- Current or previous use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic and anti-obesity drugs or other hormonal drugs;
- Intention to start a diet or a specific program of physical activity.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Insulin Sensitivity After Metformin Suspension in Normal-Weight Women With Polycystic Ovary Syndrome
Metformin is an insulin sensitizing drug routinely used for the treatment of anovulatory patients with polycystic ovary syndrome (PCOS). To date, the metabolic effects of the long-term metformin administration are know but no data are available on the effects after its suspension.
The purpose of this study is to evaluate the effects of metformin suspension on insulin sensitivity in PCOS patients.
Read the detailed description
Thirty young normal-weight anovulatory PCOS women will be enrolled. The diagnosis of PCOS will be based on the presence of clinical [Ferriman-Gallwey score ≥ 8] or biochemical hyperandrogenism (serum testosterone levels (>2 SD above our reference mean values) and chronic anovulation [serum luteal progesterone (P) below 2 ng/mL)].
Patients will be randomly allocated into two groups (metformin and placebo group) using a computer-software. Fifteen PCOS patients will be treated with metformin at a dosage of 1700 mg daily (one tablet of 850 mg twice daily; metformin group), whereas other 15 PCOS will be treated with placebo tables (one tablet twice daily; placebo group). The duration of the treatment will be 12 months. Patients will be instructed to follow their usual diet and physical activity, and to use barrier contraception throughout the study. The length and the frequency of the menstrual cycles, and the adverse experiences (AEs) will be reported on a daily diary.
Each subject will undergo follow-up visits under (at six and 12 months from treatment starting) and after treatment (at six and 12 months from treatment withdrawal). At each follow-up visit, in all subjects the same operator will perform clinical, hormonal, metabolic, and insulin sensitivity assessments by euglycemic hyperinsulinemic clamp.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Metformin cloridrate
- Keywords
- Insulin sensitivity, Insulin-sensitizing drug, Metformin, PCOS, Treatment
- Medical subject headings
- Polycystic Ovary Syndrome, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin cloridrateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity by euglycemic hyperinsulinemic clamp
Secondary outcomes (1)
Clinical, hormonal, and metabolic assessments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2007 (estimated)
- Study startDec 2003
- Study completionApr 2006
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- University Magna Graecia
- Sponsor type
- University, hospital or other
- Investigators
- Stefano Palomba, MD, Principal investigator, Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00437333
- Sponsor's protocol ID
- MM-187-2004
- Other IDs
- Prot. 2004063411_003
- Status last verified
- Feb 2007
- First submitted
- 20 Feb 2007
- Last updated
- 21 Feb 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin Sensitivity After Metformin Suspension in Normal-Weight Women With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT00437333
- Acronym / sponsor ID
- MM-187-2004
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- Insulin sensitivity, Insulin-sensitizing drug, Metformin, PCOS, Treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- University Magna GraeciaUniversity, hospital or other
- Study start
- Dec 2003
- Study completion
- Apr 2006
- First posted
- 21 Feb 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.
Metformin is an insulin sensitizing drug routinely used for the treatment of anovulatory patients with polycystic ovary syndrome (PCOS). To date, the metabolic effects of the long-term metformin administration are know but no data are available on the effects after its suspension.
The purpose of this study is to evaluate the effects of metformin suspension on insulin sensitivity in PCOS patients.
Detailed description
Thirty young normal-weight anovulatory PCOS women will be enrolled. The diagnosis of PCOS will be based on the presence of clinical [Ferriman-Gallwey score ≥ 8] or biochemical hyperandrogenism (serum testosterone levels (>2 SD above our reference mean values) and chronic anovulation [serum luteal progesterone (P) below 2 ng/mL)].
Patients will be randomly allocated into two groups (metformin and placebo group) using a computer-software. Fifteen PCOS patients will be treated with metformin at a dosage of 1700 mg daily (one tablet of 850 mg twice daily; metformin group), whereas other 15 PCOS will be treated with placebo tables (one tablet twice daily; placebo group). The duration of the treatment will be 12 months. Patients will be instructed to follow their usual diet and physical activity, and to use barrier contraception throughout the study. The length and the frequency of the menstrual cycles, and the adverse experiences (AEs) will be reported on a daily diary.
Each subject will undergo follow-up visits under (at six and 12 months from treatment starting) and after treatment (at six and 12 months from treatment withdrawal). At each follow-up visit, in all subjects the same operator will perform clinical, hormonal, metabolic, and insulin sensitivity assessments by euglycemic hyperinsulinemic clamp.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Polycystic ovary syndrome (using NIH criteria).
Key exclusion criteria (6 listed)
- Age <20 or >30 years;
- BMI higher than 25 and lower than 18;
- Neoplastic, metabolic, hepatic, and cardiovascular disorders or other concurrent medical illnesses;
- Hypothyroidism, hyperprolactinemia, Cushing's syndrome, and non-classical congenital adrenal hyperplasia;
- Current or previous use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic and anti-obesity drugs or other hormonal drugs;
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 cloridrate | Drug | – |
Primary outcome
Insulin sensitivity by euglycemic hyperinsulinemic clamp
1 secondary outcome
Clinical, hormonal, and metabolic assessments
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 21 Feb 2007.
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Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
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Safety of Cultured Allogeneic Adult Umbilical Cord or Placental Derived Mesenchymal Stem Cells for PCOS
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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.
Stefano Palomba, MD principal investigator
Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metformin cloridrate in people with Polycystic Ovary Syndrome, run by University Magna Graecia at 1 site in Italy.
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 6 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 21 Feb 2007. 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 Italy. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Insulin sensitivity by euglycemic hyperinsulinemic clamp. It is what the study was designed to measure, not a finding.
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 21 Feb 2007.