Polycystic Ovary SyndromeOMgObPCOSNCT02521753
Omega 3 Polyunsaturated Fatty Acids (PUFA) or Magnesium in Obese Polycystic Ovary Syndrome Patients
A study testing Metformin, Magnesium and PUFA in people with Polycystic Ovary Syndrome and Obesity, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
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). Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome, Obesity
- What is being tested?
- Metformin, Magnesium and PUFA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteMexico
- Study dates
- Aug 2015to Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Polycystic Ovary Syndrome according to Rotterdam criteria,
- BMI ≥ 27 Kg/m2
Who cannot join
- Type 2 diabetes mellitus,
- in treatment for polycystic ovary syndrome features
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital de Gineco Obstetricia Centro Médico "La Raza"
Mexico City, D.F., 2990
About this study
Official title: Effect Polyunsaturated Fatty Acids or Magnesium in Metabolic, Hormonal, and Inflammatory Profile in Obese Women With Polycystic Ovary Syndrome. A Randomized Clinical Trial
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.
Read the detailed description
Polycystic Ovary Syndrome (PCOS)
- Conditions
- Polycystic Ovary Syndrome, Obesity
- Being tested
- Metformin, Magnesium, PUFA
- Keywords
- Polycystic ovary syndrome, Obesity, Metformin, Magnesium, Polyunsaturated fatty acids
- Medical subject headings
- Polycystic Ovary Syndrome, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called Glucophage
Intervention also includes weight reduction diet and exercise therapy
MagnesiumDietary supplement
Also called Nature made magnesium
Intervention also includes weight reduction diet and exercise therapy
PUFADietary supplement
Also called Omega 3
Intervention also includes weight reduction diet and exercise therapy
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Active comparator | Metformin 850mg twice a day for six months Receives: Drug: Metformin |
| Magnesium | Experimental | Magnesium chloride 250mg daily for six months Receives: Dietary Supplement: Magnesium |
| PUFA omega 3 | Experimental | Eicosapentaenoic acid (EPA) + Docosahexaenoic acid (DHA) 1.1mg daily for six months Receives: Dietary Supplement: PUFA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic profile
Serum concentration of metabolic biomarkers (glucose, insulin, triglycerides, cholesterol, HDL, M and M/I value derived from a euglycemic clamp)
Measured: Six months after intervention
Secondary outcomes (1)
Hormonal profile
Serum concentration of hormones [Testosterone, dehydroepiandrosterone sulphate (DHEAs), sex hormone-binding globulin (SHBG), free androgen index (FAI)]
Measured: Six months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2020
- Study completionMar 2025
Why it stopped: It was not possible to continue recruiting due to SARSCov2 pandemia. Results obtained at that time were already published
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coordinación de Investigación en Salud, Mexico
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mardia Guadalupe Lopez Alarcon, Coordinación de Investigación en Salud, Mexico
- Investigators
- Mardia Guadalupe López Alarcón, MD, phD, Principal investigator, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02521753
- Sponsor's protocol ID
- R-2014-785-056
- Acronym
- OMgObPCOS
- Status last verified
- Mar 2025
- First submitted
- 27 Jul 2015
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: There is not a plan to share data
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Polyunsaturated Fatty Acids or Magnesium in Metabolic, Hormonal, and Inflammatory Profile in Obese Women With Polycystic Ovary Syndrome. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02521753
- Acronym / sponsor ID
- OMgObPCOS / R-2014-785-056
- Conditions
- Polycystic Ovary Syndrome, Obesity
- Keywords
- Polycystic ovary syndrome, Obesity, Metformin, Magnesium, Polyunsaturated fatty acids
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: It was not possible to continue recruiting due to SARSCov2 pandemia. Results obtained at that time were already published
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Coordinación de Investigación en Salud, MexicoOther government
- Study start
- Aug 2015 (actual)
- Primary completion
- Aug 2020 (actual)
- Study completion
- Mar 2025 (actual)
- First posted
- 13 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Polycystic Ovary Syndrome (PCOS)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Metformin | Active comparator | Drug: MetforminMetformin 850mg twice a day for six months |
| Magnesium | Experimental | Dietary Supplement: MagnesiumMagnesium chloride 250mg daily for six months |
| PUFA omega 3 | Experimental | Dietary Supplement: PUFAEicosapentaenoic acid (EPA) + Docosahexaenoic acid (DHA) 1.1mg daily for six months |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Polycystic Ovary Syndrome according to Rotterdam criteria,
- BMI ≥ 27 Kg/m2
Key exclusion criteria (2 listed)
- Type 2 diabetes mellitus,
- in treatment for polycystic ovary syndrome features
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetforminAlso: GlucophageIntervention also includes weight reduction diet and exercise therapy | Drug | Metformin |
| MagnesiumAlso: Nature made magnesiumIntervention also includes weight reduction diet and exercise therapy | Dietary supplement | Magnesium |
| PUFAAlso: Omega 3Intervention also includes weight reduction diet and exercise therapy | Dietary supplement | PUFA omega 3 |
Primary outcome
Metabolic profile
Time frame: Six months after intervention
Serum concentration of metabolic biomarkers (glucose, insulin, triglycerides, cholesterol, HDL, M and M/I value derived from a euglycemic clamp)
1 secondary outcome
Hormonal profile
Time frame: Six months after intervention
Results and safety
The study was stopped early (reason given: It was not possible to continue recruiting due to SARSCov2 pandemia. Results obtained at that time were already published). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Individual participant dataSharing planned: No. There is not a plan to share data
Related trials for Polycystic Ovary Syndrome
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Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
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The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
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The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
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Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mardia Guadalupe López Alarcón, MD, phD principal investigator
Instituto Mexicano del Seguro Social
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metformin, Magnesium and PUFA in people with Polycystic Ovary Syndrome and Obesity, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: It was not possible to continue recruiting due to SARSCov2 pandemia. Results obtained at that time were already published). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic profile (time frame: Six months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.