Polycystic Ovary Syndrome Genetics and Treatment Response
1 other identifier
interventional
200
1 country
1
Brief Summary
Polycystic ovary syndrome (PCOS) is the most common endocrine disorder in reproductive age women. Women with PCOS have a high risk of prediabetes, type 2 diabetes and heart disease. The investigators have found a possible change in the DNA (genes of the body that encode all of our traits) that seems to be related to insulin resistance. In this study, the investigators will try to determine whether the change in the gene affects a woman's ability to respond to a common treatment for PCOS, metformin. These studies will uncover the change in a gene that might be one of the causes of PCOS. Discovering this gene will help better understand the diabetes and insulin abnormalities that are common in PCOS and will help us to better diagnose and treat PCOS to prevent the diabetes in these women.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 6, 2011
CompletedFirst Posted
Study publicly available on registry
July 8, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2019
CompletedAugust 16, 2018
August 1, 2018
8.3 years
July 6, 2011
August 14, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Insulin Sensitivity
3 months
Secondary Outcomes (2)
Androgen Levels
3 months
Ovulatory Rate
3 months
Study Arms (1)
Metformin
EXPERIMENTALSubjects treated with metformin.
Interventions
Eligibility Criteria
You may qualify if:
- Polycystic ovary syndrome
- No medications for 1 month
- Good general health
You may not qualify if:
- Smoker
- Acute infection or chronic disease
- Diabetes
- Trying to get pregnant
- Bleeding disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- American Diabetes Associationcollaborator
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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: 24606093DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Medicine
Study Record Dates
First Submitted
July 6, 2011
First Posted
July 8, 2011
Study Start
June 1, 2011
Primary Completion
October 1, 2019
Study Completion
October 1, 2019
Last Updated
August 16, 2018
Record last verified: 2018-08