Combination Therapy With Myo-inositol and Folic Acid Versus Myo-inositol Alone

NCT ID: NCT01555190

Last Updated: 2020-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Polycystic Ovary Syndrome Hirsutism Menstrual Irregularity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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myo-inositol 1500 gr

6 months treatment with myo-inositol 1500 gr

Group Type ACTIVE_COMPARATOR

myo-inositol 1500 gr

Intervention Type DRUG

myo-inositol 2000gr + folic acid 200 mcg

Group Type ACTIVE_COMPARATOR

myo-inositol 2000 gr + folic acid 200 mcg

Intervention Type DRUG

Interventions

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myo-inositol 1500 gr

Intervention Type DRUG

myo-inositol 2000 gr + folic acid 200 mcg

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Catholic University of the Sacred Heart

OTHER

Sponsor Role lead

Responsible Party

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Maurizio Guido

medical doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Catholic University of Sacred Heart

Rome, , Italy

Site Status

Countries

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Italy

Other Identifiers

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000102012

Identifier Type: -

Identifier Source: org_study_id

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