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Endometrial Effects of Metformin Action in Women With Polycystic Ovarian Syndrome (PCOS)

NCT01070160 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 14

Last updated 2020-03-30

No results posted yet for this study

Summary

The investigators aim is to conduct a prospective un-blinded pilot study of premenopausal women diagnosed with Polycystic Ovarian Syndrome (PCOS), defined using criteria developed at the 1990 NICHD conference on PCOS, undergoing treatment for ovulation induction with Metformin. We propose that improving insulin sensitivity with use of Metformin in women diagnosed with PCOS has facilitatory influences on the uterine endometrium.

Conditions

  • Polycystic Ovarian Syndrome

Interventions

DRUG

Endometrin (progesterone 100mg vaginal inserts)

once a day, 6-8 days as specified (prior to each EMBx)

DRUG

Metformin

per clinical care guidelines

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Yale University

    lead OTHER

Principal Investigators

  • Lubna Pal, MBBS MRCOG MSc · Yale University

Eligibility

Min Age
18 Years
Max Age
42 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01070160 on ClinicalTrials.gov