- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01555190
Combination Therapy With Myo-inositol and Folic Acid Versus Myo-inositol Alone
July 22, 2020 updated by: Maurizio Guido, Catholic University of the Sacred Heart
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Rome, Italy, 00168
- Catholic University Of Sacred Heart
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: myo-inositol 1500 gr
6 months treatment with myo-inositol 1500 gr
|
|
Active Comparator: myo-inositol 2000gr + folic acid 200 mcg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
effects on oral glucose tollerance test
Time Frame: six months
|
six months
|
effects on hoormonal assay
Time Frame: 6 months
|
6 months
|
effects oon lipide profile
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2012
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
March 13, 2012
First Submitted That Met QC Criteria
March 14, 2012
First Posted (Estimate)
March 15, 2012
Study Record Updates
Last Update Posted (Actual)
July 24, 2020
Last Update Submitted That Met QC Criteria
July 22, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Skin Diseases
- Neoplasms
- Endocrine System Diseases
- Disease
- Ovarian Cysts
- Cysts
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Hair Diseases
- Virilism
- Polycystic Ovary Syndrome
- Syndrome
- Menstruation Disturbances
- Hirsutism
- Physiological Effects of Drugs
- Micronutrients
- Vitamins
- Vitamin B Complex
- Hematinics
- Folic Acid
- Inositol
Other Study ID Numbers
- 000102012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Polycystic Ovary Syndrome
-
Cairo UniversityCompleted
-
Alexandria UniversityRecruitingPolycystic Ovary Syndrome (PCOS)Egypt
-
Saudi German Hospital - MadinahCompletedPolycystic Ovary Syndrome (PCOS)Saudi Arabia
-
Assaf-Harofeh Medical CenterUnknownInfertility | Polycystic OvariesIsrael
-
University of CopenhagenCompletedPolycystic Ovary Syndrome (PCOS)Denmark
-
Odense University HospitalCompleted
-
Fundació Sant Joan de DéuRecruitingPolycystic Ovary Syndrome (PCOS)Norway, Austria, Denmark, Italy, Spain, Turkey
-
Riphah International UniversityCompleted
-
Dexa Medica GroupCompletedPolycystic Ovary Syndrome (PCOS)Indonesia
-
Virginia Commonwealth UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...TerminatedPolycystic Ovary Syndrome (PCOS)United States
Clinical Trials on myo-inositol 1500 gr
-
Postgraduate Institute of Dental Sciences RohtakUnknownPolycystic Ovary Syndrome | Periodontitis | Insulin Resistance
-
G. d'Annunzio UniversityUniversity of ChietiUnknown
-
Università degli Studi 'G. d'Annunzio' Chieti e...Unknown
-
AGUNCO Obstetrics and Gynecology CentreCompleted
-
Lo.Li.Pharma s.r.lWithdrawnPCOS | Myo-inositol-resistance
-
Lo.Li.Pharma s.r.lRecruiting
-
AGUNCO Obstetrics and Gynecology CentreSan Raffaele University Hospital, Italy; Research Center for Reproductive Medicine...Completed
-
Lo.Li.Pharma s.r.lCompleted
-
University of Bari Aldo MoroCompletedMenstrual Irregularity | Fertility Disorders | Lymphoma, HodgkinItaly
-
NICHD Neonatal Research NetworkEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedRetinopathy of Prematurity | Bronchopulmonary Dysplasia (BPD) | Infant, Small for Gestational Age | Infant, Premature | Infant, Low Birth Weight | Infant, NewbornUnited States