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


N/A
18 Years
42 Years
Open (Enrolling)
Female
Polycystic Ovarian Syndrome

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Trial Information

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


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.


Inclusion Criteria:



- Premenopausal between 18-42 years of age

- Diagnosed with PCOS as defined by chronic oligo- or amenorrhea (8 menstrual periods
annually); biochemical hyperandrogenemia (elevated total or free testosterone) and
/or clinical hyperandrogenism (excessive facial hair &/or acne); exclusion of common
medical disorders (normal thyroid function tests and serum prolactin and exclusion of
21-hydroxylase deficiency by a fasting 17-hydroxyprogesterone <200 ng/dl).

- Acceptable health on the basis of interview, medical history, physical examination,
and laboratory tests (CBC, SMA20, urinalysis) performed within the past 6 months

- Able to provide signed informed consent

- Able to comply with study requirements

- Willing to delay the start of clinically prescribed metformin treatment

Exclusion Criteria:

- Known diabetics or those with clinically significant and known pulmonary, cardiac,
renal, hepatic, neurologic, psychiatric, infectious, neoplastic and malignant
disease (other than non-melanoma skin cancer)

- Current use of hormonal contraceptives

- Seeking pregnancy; use of fertility drugs within 6 months of study

- Current or recent (within 3 months) use of metformin

- Ingestion of any investigational drug within two months prior to study onset

- Evidence of endometrial hyperplasia or cancer upon baseline EMBx

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

It is anticipated that endometrial expression of implantation markers will be upregulated by metformin treatment compared to baseline and improved parameters will be identified with longer duration of metformin exposure. endometrium biopsy

Outcome Time Frame:

baseline

Safety Issue:

Yes

Principal Investigator

Lubna Pal, MBBS MRCOG MSc

Investigator Role:

Principal Investigator

Investigator Affiliation:

Yale University

Authority:

United States: Institutional Review Board

Study ID:

U54 HD 052668-02

NCT ID:

NCT01070160

Start Date:

June 2009

Completion Date:

September 2013

Related Keywords:

  • Polycystic Ovarian Syndrome
  • Polycystic Ovarian Syndrome (PCOS)
  • Metformin
  • Endometrin
  • Polycystic Ovary Syndrome
  • Adenoma

Name

Location
Yale-New Haven Hospital Women's Center New Haven, Connecticut  06520-8063