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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT02521753
Other study ID # R-2014-785-056
Secondary ID
Status Suspended
Phase N/A
First received
Last updated
Start date August 2015
Est. completion date July 2024

Study information

Verified date February 2024
Source Coordinación de Investigación en Salud, Mexico
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Polycystic ovary syndrome (PCOS) is the most prevalent endocrine disorder in reproductive age women. PCOS is usually characterized by an excessive androgen production, menstrual irregularities, and polycystic ovaries. Women with PCOS are often obese and have a varying degree of insulin resistance (IR). Weight reduction constitutes the initial treatment for these patients. Metformin has proven to be useful in IR and is frequently used in PCOS. However metformin use may be accompanied by gastrointestinal discomfort, and a high abandon rate. Other therapeutic alternatives such as magnesium and polyunsaturated fatty acids have been used in other IR states and may be useful in PCOS. The aim of this study is to asses the efficacy of these alternatives in obese PCOS patients.


Description:

Polycystic Ovary Syndrome (PCOS)


Recruitment information / eligibility

Status Suspended
Enrollment 123
Est. completion date July 2024
Est. primary completion date August 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 38 Years
Eligibility Inclusion Criteria: - Polycystic Ovary Syndrome according to Rotterdam criteria, - BMI = 27 Kg/m2 Exclusion Criteria: - Type 2 diabetes mellitus, - in treatment for polycystic ovary syndrome features

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Metformin
Intervention also includes weight reduction diet and exercise therapy
Dietary Supplement:
Magnesium
Intervention also includes weight reduction diet and exercise therapy
PUFA
Intervention also includes weight reduction diet and exercise therapy

Locations

Country Name City State
Mexico Hospital de Gineco Obstetricia Centro Médico "La Raza" Mexico City D.f.

Sponsors (1)

Lead Sponsor Collaborator
Coordinación de Investigación en Salud, Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type Measure Description Time frame Safety issue
Primary Metabolic profile Serum concentration of metabolic biomarkers (glucose, insulin, triglycerides, cholesterol, HDL, M and M/I value derived from a euglycemic clamp) Six months after intervention
Secondary Hormonal profile Serum concentration of hormones [Testosterone, dehydroepiandrosterone sulphate (DHEAs), sex hormone-binding globulin (SHBG), free androgen index (FAI)] Six months after intervention
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