An interventional study of Myo-inositol+L-tyrosine in Polycystic Ovary Syndrome, Menstrual Problem and Hirsutism, sponsored by Pharmarte srl. Completed at 1 site in Italy. Open to female participants aged 16 Years to 38 Years. Per ClinicalTrials.gov, last updated 2020-06-16.
Sponsored by Pharmarte srl · Not applicable, Interventional, and Treatment
PCOS patients were treated every day, with one sachet containing 2000 mg myo-inositol, 500 mg L-tyrosine, 40 mcg chromium picolinate, 55 mcg selenium, 200 mcg folic acid. All patients underwent, before starting the therapy, after 3 months and 6 months, hormonal evaluation , hirsutism scoring and ovulation assesment. Most of them during the treatment improved their symptoms.
956 studies on the registry are indexed under Polycystic Ovary Syndrome; 176 are open to participants now.
This study's enrollment of 186 is above the median of 70 across 697 interventional studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →This is the only study on the registry with Pharmarte srl as lead sponsor.
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° PCOS patients
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
One sachet per day containing 2000 mg myo-inositol, 500 mg L-tyrosine, 40 mcg chromium picolinate, 55 mcg selenium, 200 mcg folic acid for improving PCOS symptoms.
Dietary Supplement: Myo-inositol+L-tyrosine
Drug pages: Inositol · Tyrosine
PCOS patients were treated every day, with one sachet containing 2000 mg myo-inositol, 500 mg L-tyrosine, 40 mcg chromium picolinate, 55 mcg selenium, 200 mcg folic acid. All patients underwent, before starting the therapy, after 3 months and 6 months, hormonal, hirsutism and ovulation assesment.
Restore of regular menstrual period
Self report
Time frame: 6 months of treatment
Improving hirsutism
Standardised visual scales are preferred when assessing hirsutism, such as the modified Ferriman Gallwey score (mFG) with a level ≥ 4 - 6 indicating hirsutism,
Time frame: 6 months of treatment
Restore ovulation
Progesterone value in luteal phase
Time frame: 6 months of treatment
Ran from May 2017 to primary completion in Aug 2018, 15 months.
Of 217 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 15 months is below that.
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This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Inositol · Tyrosine