NCT02198417

Brief Summary

PCOS occurs when a woman does not release an egg regularly each month, causing her periods to be irregular. Women with PCOS can also have increased hair growth on the face and body, acne, head balding, infertility, pre-diabetes, and diabetes. PCOS is commonly treated with oral contraceptive pills (also known as the birth control pills). Sometimes, a medication called metformin is also used to treat PCOS, especially if a woman has evidence of insulin resistance or if fertility is desired. Unfortunately, metformin works in only some women with PCOS. The mechanism through which metformin works in PCOS is not clear and it difficult to predict who will benefit from metformin treatment and who will not. The investigators are doing this research study to look at how the medication metformin affects the cells in the body of patients with PCOS. Specifically, the investigators will look at how metformin affects the mitochondria. Mitochondria are the part of cells that produce fuel (energy) for other cells and play a role in metabolism. The investigators would like to see whether there is a relationship between mitochondrial activity and symptoms of polycystic ovary syndrome (PCOS) before and after treatment with metformin. They would also like to study whether genes affect the response to metformin in women with PCOS.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2014

Longer than P75 for not_applicable

Status
unknown

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

Study Start

First participant enrolled

July 1, 2014

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

July 17, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 23, 2014

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

August 16, 2018

Status Verified

August 1, 2018

Enrollment Period

6.2 years

First QC Date

July 17, 2014

Last Update Submit

August 14, 2018

Conditions

Polycystic Ovary Syndrome

Keywords

Polycystic Ovary SyndromePCOSAcneInfertilityIrregular mensesIrregular periodMitochondriaMetabolism

Outcome Measures

Primary Outcomes (1)

  • Muscle Metabolism/Mitochondrial Function

    The change in mitochondrial activity before and after metformin treatment will be analyzed in relationship to the clinical response to 3 months of metformin treatment (i.e., clinical response to metformin = changes in glucose metabolism, hormone levels, and ovulation response)

    3 months

Secondary Outcomes (1)

  • Genetic risk variants affecting mitochondrial function/metabolism

    3 months

Study Arms (1)

Metformin

EXPERIMENTAL

Metformin ER 1500 mg per day treatment for 12 weeks

Drug: Metformin ER

Interventions

Metformin ERDRUG

Treatment with metformin ER for 12 weeks

Also known as: Glucophage
Metformin

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Polycystic ovary syndrome
  • No hormonal or antidiabetic medications for 1 month
  • Good general health

You may not qualify if:

  • Smoker
  • Acute infection or chronic disease
  • Diabetes
  • Pregnant or trying to get pregnant over next half year
  • Bleeding disorders
  • Any metal or foreign implants (e.g., aneurysm clips, ear implants, heart pacemakers or defibrillators)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Pau CT, Keefe C, Duran J, Welt CK. Metformin improves glucose effectiveness, not insulin sensitivity: predicting treatment response in women with polycystic ovary syndrome in an open-label, interventional study. J Clin Endocrinol Metab. 2014 May;99(5):1870-8. doi: 10.1210/jc.2013-4021. Epub 2014 Feb 25.

    PMID: 24606093BACKGROUND

MeSH Terms

Conditions

Polycystic Ovary SyndromeAcne VulgarisInfertilityMenstruation Disturbances

Interventions

Metformin

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesAcneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Corrine Welt, M.D.

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

July 17, 2014

First Posted

July 23, 2014

Study Start

July 1, 2014

Primary Completion

September 1, 2020

Study Completion

December 1, 2020

Last Updated

August 16, 2018

Record last verified: 2018-08