NCT01070160

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 14 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: Female
• Age: 18 Years – 42 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Endometrial assessments are proposed following three month and then nine month treatment with metformin; expression of specified markers at respective time points will be compared to baseline. Visit 1: Screening * Signed informed consent * Comprehensive history intake * Physical exam: Vital signs, height, weight, waist circumferences, waist : hip ratio * Urine pregnancy test * Subjects provided with a 10 day supply of vaginal progesterone and EMBx will be scheduled between days 6-8 of progesterone use. Visit 2: Baseline * Urine pregnancy test * Endometrium thickness will be measured via transvaginal ultrasound * EMBx: sample of endometrial tissue will be sent for histopathology to rule out endometrial hyperplasia or cancer * 20cc blood * Metformin prescription and dispensing will be as per clinical care. * Women will be advised to use barrier method of contraception (ie; condoms, contraceptive jellies or foam, sponge, diaphragm, or cervical cap) for the duration of the study. Visits 3 and 5 (Weeks 8-10 and 30-34, respectively) * Urine pregnancy test * A 10 day course of vaginal progesterone to allow scheduling of EMBx's time points specified under visit 1 Visits 4 and 6 (Weeks 12 ± 1 week and 36 ± 1 week respectively) \- The procedure specified for baseline (Visit 2) will be repeated.

Conditions

• Polycystic Ovarian Syndrome

Interventions

Type	Name	Description
DRUG	Endometrin (progesterone 100mg vaginal inserts)	once a day, 6-8 days as specified (prior to each EMBx)
DRUG	Metformin	per clinical care guidelines

Timeline

• Start date: 2009-06-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2010-02-17
• Last updated: 2020-03-30

Locations

1 site across 1 country: United States