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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01555190
Other study ID # 000102012
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2012
Est. completion date December 2013

Study information

Verified date July 2020
Source Catholic University of the Sacred Heart
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria:

- women with PCOS diagnosed in accordance with Rotterdam Consensus Conference Criteria 2003

- BMI > 25 kg/m2

- age 18-35 years

Exclusion Criteria:

- 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.

Study Design


Intervention

Drug:
myo-inositol 1500 gr

myo-inositol 2000 gr + folic acid 200 mcg


Locations

Country Name City State
Italy Catholic University of Sacred Heart Rome

Sponsors (1)

Lead Sponsor Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary number of cycles in six months of therapy We'll estimate the efficacy of the two treatments on the ovarian function and menstrual pattern. 6 months
Secondary effects on oral glucose tollerance test six months
Secondary effects on hoormonal assay 6 months
Secondary effects oon lipide profile 6 months
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