NCT02521753

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2015

Completed
5 days until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 13, 2015

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
4.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

April 1, 2025

Status Verified

March 1, 2025

Enrollment Period

5 years

First QC Date

July 27, 2015

Last Update Submit

March 27, 2025

Conditions

Polycystic Ovary SyndromeObesity

Keywords

Polycystic ovary syndromeObesityMetforminMagnesiumPolyunsaturated fatty acids

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Hormonal profile

    Six months after intervention

Study Arms (3)

Metformin

ACTIVE COMPARATOR

Metformin 850mg twice a day for six months

Drug: Metformin

Magnesium

EXPERIMENTAL

Magnesium chloride 250mg daily for six months

Dietary Supplement: Magnesium

PUFA omega 3

EXPERIMENTAL

Eicosapentaenoic acid (EPA) + Docosahexaenoic acid (DHA) 1.1mg daily for six months

Dietary Supplement: PUFA

Interventions

MetforminDRUG

Intervention also includes weight reduction diet and exercise therapy

Also known as: Glucophage
Metformin
MagnesiumDIETARY_SUPPLEMENT

Intervention also includes weight reduction diet and exercise therapy

Also known as: Nature made magnesium
Magnesium
PUFADIETARY_SUPPLEMENT

Intervention also includes weight reduction diet and exercise therapy

Also known as: Omega 3
PUFA omega 3

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Polycystic Ovary Syndrome according to Rotterdam criteria,
  • BMI ≥ 27 Kg/m2

You may not qualify if:

  • Type 2 diabetes mellitus,
  • in treatment for polycystic ovary syndrome features

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Gineco Obstetricia Centro Médico "La Raza"

Mexico City, D.F., 2990, Mexico

Location

MeSH Terms

Conditions

Polycystic Ovary SyndromeObesity

Interventions

MetforminMagnesiumDocosahexaenoic Acids

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsMetals, Alkaline EarthElementsInorganic ChemicalsMetals, LightMetalsFatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Officials

  • Mardia Guadalupe López Alarcón, MD, phD

    Instituto Mexicano del Seguro Social

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
The study is open label. No blindness for participant or investigator is used
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigador titular B

Study Record Dates

First Submitted

July 27, 2015

First Posted

August 13, 2015

Study Start

August 1, 2015

Primary Completion

August 1, 2020

Study Completion

March 1, 2025

Last Updated

April 1, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

There is not a plan to share data

Locations

ME(1)