Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2026-01-26 @ 7:16 AM
Study NCT ID:
NCT01070160
Status:
COMPLETED
Last Update Posted:
2020-03-30
First Post:
2010-02-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endometrial Effects of Metformin Action in Women With Polycystic Ovarian Syndrome (PCOS)
Sponsor:
Yale University
Organization:
Study Overview
Official Title:
Endometrial Effects of Metformin Action in Women With Polycystic Ovarian Syndrome (PCOS)
Status:
COMPLETED
Status Verified Date:
2014-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U54HD052668-02 | NIH | None | https://reporter.nih.gov/quic… | View |