Polycystic Ovary SyndromePhase 4NCT01366391
Therapeutic Monitoring of Metformin in Women With Polycystic Ovary Syndrome
A Phase 4 study testing Metformin in people with Polycystic Ovary Syndrome, run by Biocinese at 1 site in Brazil.
Trial summary
Metformin is one of the most commonly prescribed drugs worldwide for the treatment of Type 2 Diabetes. It has been currently used for the treatment of: polycystic ovary syndrome, gestational diabetes, metabolic syndrome and obesity. Read more about this study
- Who is it for?
- Ages 18 to 40 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?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2011to Oct 2011
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged between 18 and 40 years old, with no use of contraceptive drugs or insulin sensitizing agents for more than 3 months.
- PCOS diagnosis.
- Insulin resistance Index by the Homeostatic model Assessment Formula higher than 2.5.
Who cannot join
- Another diseases with androgen excess;
- Patients with history of serious adverse reaction or hypersensibility to any medicine;
- History or presence of renal, hepatic or gastrointestinal disorders.
- Continuous use of any pharmaco, inclusively metformin
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Biocinese
Toledo, Paraná, 85903-590
Joselia Manfio, Dr, +55 45 2103 1907, manfiojoselia@bol.com.br
Naura Angonese, Dr, +55 45 2103 1900, naura.tonin@hotmail.com
About this study
Metformin is one of the most commonly prescribed drugs worldwide for the treatment of Type 2 Diabetes. It has been currently used for the treatment of: polycystic ovary syndrome, gestational diabetes, metabolic syndrome and obesity. In patients with polycystic ovary syndrome (PCOS) the adverse side effects are a frequent cause for treatment discontinuation. In every day medical practice lower doses of Metformin are administered searching for the continuation of the treatment.
However, there is no clinical study to support this assertion. The objective of this study is to monitor and correlate the therapeutic effect of Metformin on patients with PCOS taking daily doses of 1500mg and 1000mg.
Read the detailed description
Patients with PCOS diagnosis and that are able to attempt the inclusion criteria are divided in two groups: administration of metformin 500 mg tablet three times/day as well 1500 mg/day (group A)and administration of metformin 500 mg tablet twice/day or 1000 mg/day (group B). Blood samples were collected to the pharmacokinetic evaluation from first day of administration until 3 months after beginning of treatment. The patients are monitored during 3 months and all side effects are register. The efficacy of both treatment are analyzed by biochemical and physical evaluation.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Metformin
- Keywords
- polycystic ovary syndrome, metformin, pharmacokinetic
- 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 Glifage 500 mg
Metformin 500 mg tablet (1000 or 1500 mg/day)
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Other | study parallel with one arm only. Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration of metformin
Blood samples are collected from each patient and the plasma concentration is analysed.
Measured: First day after administration until 3 months after begining of treatment
Secondary outcomes (1)
Number of adverse events
All adverse events are registered during the treatment
Measured: observation during 3 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2011 (estimated)
- Study startJan 2011
- Primary completionAug 2011 (estimated)
- Study completionOct 2011 (estimated)
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
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biocinese
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Naura Angonese, Dr, Principal investigator, Biocinese
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01366391
- Sponsor's protocol ID
- 0038.0 208.00-09
- Status last verified
- Jun 2011
- First submitted
- 2 Jun 2011
- Last updated
- 6 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Monitoring of Metformin in Women With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT01366391
- Acronym / sponsor ID
- 0038.0 208.00-09
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- polycystic ovary syndrome, metformin, pharmacokinetic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- BiocineseIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Aug 2011 (estimated)
- Study completion
- Oct 2011 (estimated)
- First posted
- 6 Jun 2011 (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 one of the most commonly prescribed drugs worldwide for the treatment of Type 2 Diabetes. It has been currently used for the treatment of: polycystic ovary syndrome, gestational diabetes, metabolic syndrome and obesity. In patients with polycystic ovary syndrome (PCOS) the adverse side effects are a frequent cause for treatment discontinuation. In every day medical practice lower doses of Metformin are administered searching for the continuation of the treatment.
However, there is no clinical study to support this assertion. The objective of this study is to monitor and correlate the therapeutic effect of Metformin on patients with PCOS taking daily doses of 1500mg and 1000mg.
Detailed description
Patients with PCOS diagnosis and that are able to attempt the inclusion criteria are divided in two groups: administration of metformin 500 mg tablet three times/day as well 1500 mg/day (group A)and administration of metformin 500 mg tablet twice/day or 1000 mg/day (group B). Blood samples were collected to the pharmacokinetic evaluation from first day of administration until 3 months after beginning of treatment. The patients are monitored during 3 months and all side effects are register. The efficacy of both treatment are analyzed by biochemical and physical evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metformin | Other | Drug: Metforminstudy parallel with one arm only. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients aged between 18 and 40 years old, with no use of contraceptive drugs or insulin sensitizing agents for more than 3 months.
- PCOS diagnosis.
- Insulin resistance Index by the Homeostatic model Assessment Formula higher than 2.5.
Key exclusion criteria (4 listed)
- Another diseases with androgen excess;
- Patients with history of serious adverse reaction or hypersensibility to any medicine;
- History or presence of renal, hepatic or gastrointestinal disorders.
- Continuous use of any pharmaco, inclusively metformin
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: Glifage 500 mgMetformin 500 mg tablet (1000 or 1500 mg/day) | Drug | Metformin |
Primary outcome
Plasma concentration of metformin
Time frame: First day after administration until 3 months after begining of treatment
Blood samples are collected from each patient and the plasma concentration is analysed.
1 secondary outcome
Number of adverse events
Time frame: observation during 3 months of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2011.
Related trials for Polycystic Ovary Syndrome
Recruiting
Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS
PCOS (Polycystic Ovary Syndrome)
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingObservational study
The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
Polycystic Ovary Syndrome (PCOS)
Recruiting
The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome)
Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Polycystic Ovary Syndrome (PCOS)
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.
Naura Angonese, Dr principal investigator
Biocinese
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 in people with Polycystic Ovary Syndrome, run by Biocinese at 1 site in Brazil.
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 3 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 6 Jun 2011. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Naura Angonese, Dr (+55 45 2103 1900, naura.tonin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma concentration of metformin (time frame: First day after administration until 3 months after begining of treatment). 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 6 Jun 2011.