An interventional study of myo-inositol 1500 gr and myo-inositol 2000 gr + folic acid 200 mcg in Polycystic Ovary Syndrome, Hirsutism and Menstrual Irregularity, sponsored by Catholic University of the Sacred Heart. Completed at 1 site in Italy. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-24.
Sponsored by Catholic University of the Sacred Heart · Not applicable, Interventional, and Treatment
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.
956 studies on the registry are indexed under Polycystic Ovary Syndrome; 176 are open to participants now.
This study's enrollment of 50 is below the median of 70 across 697 interventional studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →Catholic University of the Sacred Heart is the lead sponsor of 237 studies on the registry; 29 are open to participants now.
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Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
6 months treatment with myo-inositol 1500 gr
Drug: myo-inositol 1500 gr
Drug: myo-inositol 2000 gr + folic acid 200 mcg
number of cycles in six months of therapy
We'll estimate the efficacy of the two treatments on the ovarian function and menstrual pattern.
Time frame: 6 months
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
Ran from Jan 2012 to primary completion in Dec 2013, 23 months.
Of 202 non-industry interventional studies with no phase under Polycystic Ovary Syndrome, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 39. This study's 23 months is above that.
Counting every sponsor, half of 217 studies reached it within 18 months; a quarter within 7 and three quarters within 39.
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This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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