Polycystic Ovary SyndromeNCT02984722
Extended-release vs Immediate-release Metformin in PCOS Women
A study testing Metformin in people with Polycystic Ovary Syndrome, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial summary
The aim of our study is to compare the different effects of 6 months treatment with extended-release metformin and immediate-release metformin on clinical, endocrine and metabolic parameters in women affected by polycystic ovary syndrome. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2016to Dec 2017
- 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 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women with PCOS in accordance with Rotterdam criteria
Who cannot join
- pregnancy
- diabetes mellitus (or impaired glucose tolerance as determined by a standard 75 gr oral glucose tolerance test)
- past history of cardiovascular diseases
- past history of gastro-intestinal diseases
- significant liver or renal dysfunction (hypothalamic, pituitary, thiroidal or adrenal);
- neoplasms.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of our study is to compare the different effects of 6 months treatment with extended-release metformin and immediate-release metformin on clinical, endocrine and metabolic parameters in women affected by polycystic ovary syndrome. We also evaluate gastrointestinal disorders associated with the two different compouds.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Metformin
- Keywords
- PCOS, metformin
- 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
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | PCOS women treated with 1500 mg/die of extended-release metformin Receives: Drug: Metformin |
| 2 | Experimental | PCOS women treated with 1500 mg/die of immediate-release metformin Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastro intestinal disorders
Measured: 6 months
Secondary outcomes (10)
number of cycles in 6 months of therapy
Measured: 6 months
insulin levels
Measured: 6 months
hirsutism score
Measured: 6 months
androstenedione levels
Measured: 6 months
testosterone levels
Measured: 6 months
free androgen index
Measured: 6 months
dheas levels
Measured: 6 months
ovarian volume
Measured: 6 months
total cholesterol
Measured: 6 months
tryglycerides levels
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2017 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rosanna Apa, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02984722
- Sponsor's protocol ID
- Metformin XR
- Status last verified
- Dec 2016
- First submitted
- 3 Dec 2016
- Last updated
- 7 Dec 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended-release vs Immediate-release Metformin in PCOS Women
- ClinicalTrials.gov ID
- NCT02984722
- Acronym / sponsor ID
- Metformin XR
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- PCOS, metformin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2017 (estimated)
- First posted
- 7 Dec 2016 (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.
The aim of our study is to compare the different effects of 6 months treatment with extended-release metformin and immediate-release metformin on clinical, endocrine and metabolic parameters in women affected by polycystic ovary syndrome. We also evaluate gastrointestinal disorders associated with the two different compouds.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: MetforminPCOS women treated with 1500 mg/die of extended-release metformin |
| 2 | Experimental | Drug: MetforminPCOS women treated with 1500 mg/die of immediate-release metformin |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- women with PCOS in accordance with Rotterdam criteria
Key exclusion criteria (6 listed)
- pregnancy
- diabetes mellitus (or impaired glucose tolerance as determined by a standard 75 gr oral glucose tolerance test)
- past history of cardiovascular diseases
- past history of gastro-intestinal diseases
- significant liver or renal dysfunction (hypothalamic, pituitary, thiroidal or adrenal);
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 | 1, 2 |
Primary outcome
Gastro intestinal disorders
Time frame: 6 months
10 secondary outcomes
number of cycles in 6 months of therapy
Time frame: 6 months
insulin levels
Time frame: 6 months
hirsutism score
Time frame: 6 months
androstenedione levels
Time frame: 6 months
testosterone levels
Time frame: 6 months
free androgen index
Time frame: 6 months
dheas levels
Time frame: 6 months
ovarian volume
Time frame: 6 months
total cholesterol
Time frame: 6 months
tryglycerides levels
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metformin in people with Polycystic Ovary Syndrome, run by Catholic University of the Sacred Heart 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: status not confirmed, as of the sponsor's last update on 7 Dec 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 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.
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.
What does the primary outcome measure?
Gastro intestinal disorders (time frame: 6 months). 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 7 Dec 2016.