Polycystic Ovary SyndromeNCT01555190
Combination Therapy With Myo-inositol and Folic Acid Versus Myo-inositol Alone
A study testing myo-inositol 1500 gr and myo-inositol 2000 gr + folic acid 200 mcg in people with Polycystic Ovary Syndrome and Hirsutism, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial summary
Previous studies have demonstrated that Myo-inositol is capable of restoring spontaneous ovarian activity, and consequently fertility, in most patients with PCOS. The aim of our study is to investigate the role of folic acid conteined in the inositol preparation. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome, Hirsutism, Menstrual Irregularity
- What is being tested?
- myo-inositol 1500 gr and myo-inositol 2000 gr + folic acid 200 mcg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2012to Dec 2013
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- women with PCOS diagnosed in accordance with Rotterdam Consensus Conference Criteria 2003
- BMI > 25 kg/m2
- age 18-35 years
Who cannot join
- pregnancy
- significant liver or renal impairment
- other hormonal dysfunctions (hypothalamic, pituitary, thyroidal or adrenal causes for the clinical signs)
- neoplasms
- unstable mental illness
- diagnosis of diabetes mellitus or impaired glucose tolerance
- use of drugs able to interfere with gluco-insulinaemic metabolism for at least three months prior entering the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combination Therapy With Myo-inositol and Folic Acid Versus Myo-inositol Alone: Effects of Six Months Treatment on Clinical, Endocrine and Metabolic Features in Obese Women With Polycystic Ovary Syndrome
Previous studies have demonstrated that Myo-inositol is capable of restoring spontaneous ovarian activity, and consequently fertility, in most patients with PCOS. The aim of our study is to investigate the role of folic acid conteined in the inositol preparation. The study group included 50 patients, randomly allocated to subgroup A (myo-inositol 1500 gr) and subgroup B (myo-inositol 2000 gr + folic acid 200 mcg). The investigation include menstrual pattern and hirsutism score evaluation, hormonal assays, oral glucose tolerance test, euglycemic hyperinsulinaemic clamp and lipide profile at baseline and after six months of treatment.
- Conditions
- Polycystic Ovary Syndrome, Hirsutism, Menstrual Irregularity
- Being tested
- myo-inositol 1500 gr, myo-inositol 2000 gr + folic acid 200 mcg
- Keywords
- myo-inositol, folic acid
- Medical subject headings
- Polycystic Ovary Syndrome, Hirsutism, Menstruation Disturbances
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
myo-inositol 1500 grDrug
myo-inositol 2000 gr + folic acid 200 mcgDrug
| Study group | Role | What they receive |
|---|---|---|
| myo-inositol 1500 gr | Active comparator | 6 months treatment with myo-inositol 1500 gr Receives: Drug: myo-inositol 1500 gr |
| myo-inositol 2000gr + folic acid 200 mcg | Active comparator | Not described Receives: Drug: myo-inositol 2000 gr + folic acid 200 mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of cycles in six months of therapy
We'll estimate the efficacy of the two treatments on the ovarian function and menstrual pattern.
Measured: 6 months
Secondary outcomes (3)
effects on oral glucose tollerance test
Measured: six months
effects on hoormonal assay
Measured: 6 months
effects oon lipide profile
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 posted15 Mar 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2013
- Study completionDec 2013
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maurizio Guido, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01555190
- Sponsor's protocol ID
- 000102012
- Status last verified
- Jul 2020
- First submitted
- 13 Mar 2012
- Last updated
- 24 Jul 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Therapy With Myo-inositol and Folic Acid Versus Myo-inositol Alone: Effects of Six Months Treatment on Clinical, Endocrine and Metabolic Features in Obese Women With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT01555190
- Acronym / sponsor ID
- 000102012
- Conditions
- Polycystic Ovary Syndrome, Hirsutism, Menstrual Irregularity
- Keywords
- myo-inositol, folic acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- Jan 2012 (actual)
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 15 Mar 2012 (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.
Previous studies have demonstrated that Myo-inositol is capable of restoring spontaneous ovarian activity, and consequently fertility, in most patients with PCOS. The aim of our study is to investigate the role of folic acid conteined in the inositol preparation. The study group included 50 patients, randomly allocated to subgroup A (myo-inositol 1500 gr) and subgroup B (myo-inositol 2000 gr + folic acid 200 mcg). The investigation include menstrual pattern and hirsutism score evaluation, hormonal assays, oral glucose tolerance test, euglycemic hyperinsulinaemic clamp and lipide profile at baseline and after six months of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| myo-inositol 1500 gr | Active comparator | Drug: myo-inositol 1500 gr6 months treatment with myo-inositol 1500 gr |
| myo-inositol 2000gr + folic acid 200 mcg | Active comparator | Drug: myo-inositol 2000 gr + folic acid 200 mcg |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- women with PCOS diagnosed in accordance with Rotterdam Consensus Conference Criteria 2003
- BMI > 25 kg/m2
- age 18-35 years
Key exclusion criteria (7 listed)
- pregnancy
- significant liver or renal impairment
- other hormonal dysfunctions (hypothalamic, pituitary, thyroidal or adrenal causes for the clinical signs)
- neoplasms
- unstable mental illness
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 |
|---|---|---|
| myo-inositol 1500 gr | Drug | myo-inositol 1500 gr |
| myo-inositol 2000 gr + folic acid 200 mcg | Drug | myo-inositol 2000gr + folic acid 200 mcg |
Primary outcome
number of cycles in six months of therapy
Time frame: 6 months
We'll estimate the efficacy of the two treatments on the ovarian function and menstrual pattern.
3 secondary outcomes
effects on oral glucose tollerance test
Time frame: six months
effects on hoormonal assay
Time frame: 6 months
effects oon lipide profile
Time frame: 6 months
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 24 Jul 2020.
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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 myo-inositol 1500 gr and myo-inositol 2000 gr + folic acid 200 mcg in people with Polycystic Ovary Syndrome and Hirsutism, 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 3 inclusion and 7 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 24 Jul 2020. 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?
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?
number of cycles in six months of therapy (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 24 Jul 2020.