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View Clinical Trial (Medical Research Study)
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Pharmacogenetics of Metformin Action in PCOS - NCT00703508-06510 (Clinical Trial 228578)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy228578.aspx
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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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06510 |
| Conditions: |
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Polycystic Ovary Syndrome |
| Purpose: |
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1. The polycystic ovary syndrome is the major cause of infertility in the United States.
Metformin has been shown to increase frequency of ovulations in PCOS, and is used in
clinical practice to treat infertility, but some women with PCOS do not respond to
metformin treatment.
2. Knowing that a specific gene predicts the effect of metformin on ovulation would
facilitate more efficient and effective treatment of infertility in PCOS.
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| Study summary: |
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The polycystic ovary syndrome (PCOS) affects approximately 6-10% of women of childbearing
age, i.e., 3.5-5.5 million women in the United States. PCOS is the most common endocrine
disturbance of young women and the major cause (75%) of anovulatory infertility in the
United States. We hypothesize that women with the polycystic ovary syndrome (PCOS) who have
the G/G genotype of single nucleotide polymorphism (SNP)_ rs8111699 in STK11 will exhibit a
significantly greater response to metformin, in terms of ovulation, compared with women with
either the C/G or C/C genotype. Specifically, we anticipate the frequency of ovulation
(defined by number of ovulations/9 months/subject) to be at least 2-fold higher in women
with the G/G STK11 genotype compared with women with either the C/G or C/C genotype.
To test this hypothesis, we will obtain DNA for STK11 genotyping in 152 women with PCOS who
are treated with metformin and carefully monitored for ovulation for 9 months. STK11
genotype status will be determined, and the ovulation rates in the G/G, G/C and C/C genotype
groups will be compared with one another. Our goal is to identify the genes that predict or
modify response to commonly prescribed medications that will allow physicians to better
choose among existing therapies and individualize treatment. While metformin has been shown
to increase ovulatory frequency in PCOS and is widely used in clinical practice to treat
infertility, a substantial number of women either do not respond or are slow to respond to
metformin treatment.
Knowing that a specific STK11 genotype predicts the effect of metformin on ovulation would
facilitate more efficient and effective treatment of infertility in PCOS. |
| Criteria: |
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Inclusion Criteria:
- Premenopausal women between 18-40 years of age and BMI less than 40
- Diagnosed with PCOS as defined by chronic oligo-or amenorrhea (less than 8 menstrual
periods annually); biochemical hyperandrogenemia (elevated total or free
testosterone); normal thyroid function tests and serum prolactin; and exclusion of 21
alpha hydroxylase deficiency by a fasting 17 alpha hydroxyprogesterone less than 200
ng/dl -In acceptable health on the basis of interview, medical history, physical
examination, and laboratory tests (CBC, SMA20,urinanalysis) -Able to provide signed,
witnessed informed consent -Able to comply with study requirements
Exclusion Criteria:
-Diabetes mellitus by fasting glucose or OGTT, or clinically significant pulmonary,
cardiac,renal,hepatic,neurologic,psychiatric,infectious,neoplastic and malignant disease
(other than non-melanoma skin cancer) -Current use of oral contraceptives -seeking
pregnancy; use of fertility drugs within 6 months of study -Current or recent use (within
3 months prior to study entry) of metformin -Documented or suspected recent (within one
year)history of drug abuse or alcoholism -Ingestion of any investigational drug within two
months prior to study onset. |
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| Study is available at: |
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Yale University YCCI/Hospital Research Unit (HRU)
New Haven, CT 06510
United States
Primary Contact:
Luisa Coraluzzi, BSN
Email: luisa.coraluzzi@yale.edu
Phone: 203-785-4016
Secondary Contact:
Manar T. Nazmy
Email: mtnazmy@vcu.edu
Phone: 804-827-0171 |
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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 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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