View Clinical Trial (Medical Research Study)
Endometrial Effects of Metformin Action in Women With Polycystic Ovarian Syndrome (PCOS) - NCT01070160-06520(Clinical Trial 562221)
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| City: |
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New Haven |
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State:
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CT |
| Zip Code: |
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06520 |
| Conditions: |
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Polycystic Ovary Syndrome |
| Purpose: |
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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.
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| Study summary: |
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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. |
| Criteria: |
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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 |
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| Study is available at: |
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Yale-New Haven Hospital Women's Center
New Haven, CT 06520
United States
Primary Contact:
Lubna Pal, MBBS MRCOG MSc
Email: lubna.pal@yale.edu
Phone: (203)-737-5619
Secondary Contact:
Lubna Pal, MBBS MRCOG MSc
Email: lubna.pal@yale.edu
Phone: (203)-737-5619 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 23, 2011 |
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