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| Sponsored by: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
|---|---|
| Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| ClinicalTrials.gov Identifier: | NCT00703508 |
Purpose
| Condition | Intervention |
|---|---|
|
Polycystic Ovary Syndrome |
Drug: Metformin |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics/Dynamics Study |
| Official Title: | Pharmacogenetics of Metformin Action in PCOS |
| Estimated Enrollment: | 152 |
| Study Start Date: | July 2008 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
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.
Contacts and Locations| Contact: Manar T. Nazmy | 804-827-0171 | mtnazmy@vcu.edu |
| Contact: Terre Y. Williams | 804-828-2663 | tywillia@vcu.edu |
| United States, Virginia | |
| Virginia Commonwealth University General Clinical Research Center | Recruiting |
| Richmond, Virginia, United States, 23298 | |
| Contact: Manar T Nazmy, MD 804-827-0171 mtnazmy@vcu.edu | |
| Contact: Terre Y Williams 804-828-2663 tywillia@vcu.edu | |
| Principal Investigator: John E. Nestler, MD | |
| Principal Investigator: | John E. Nestler, M.D. | Virginia Commonwealth University |
More Information
| Responsible Party: | Virginia Commonwealth University ( John E. Nestler, MD ) |
| Study ID Numbers: | VCU IRB HM11153, 2U54HD034449 |
| Study First Received: | June 20, 2008 |
| Last Updated: | October 28, 2008 |
| ClinicalTrials.gov Identifier: | NCT00703508 |
| Health Authority: | United States: Federal Government |
|
PCOS |
|
Genital Diseases, Female Gonadal Disorders Metformin Polycystic Ovary Syndrome Endocrine System Diseases |
Endocrinopathy Ovarian Diseases Cysts Ovarian Cysts |
|
Neoplasms Hypoglycemic Agents Pathologic Processes Disease |
Syndrome Physiological Effects of Drugs Pharmacologic Actions Adnexal Diseases |
