N/A N=26 Treatment

Pharmacogenetics of Metformin Action in PCOS

Polycystic Ovary Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT00703508 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2017

Primary outcome: Primary: Number of Responders/Non-responders for Each STK11 rs8111699 Genotype (C/G, C/C, G/G) — 6; 7; 5; 3 participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Metformin 500 mg tablet (Drug)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: Virginia Commonwealth University
Primary completion: Sep 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Responders/Non-responders for Each STK11 rs8111699 Genotype (C/G, C/C, G/G)	6; 7; 5; 3; 4; 1	—
PRIMARY Ovulation Rate Over Study Duration for STK11 Genotypes CC, CG and GG	0.47; 0.36; 0.34	—
SECONDARY Determine in Which Genotype(s) Frequency of Ovulation Correlates With Improvement in Reduction in Total Testosterone and Insulin Sensitivity as Measured by the Matsuda Index.	0.138956; 0.035449; 0.049263; 0.27144; 0.01918; 0.132059	0.0234 sig

Summary

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.

Eligibility Criteria

Inclusion Criteria

Premenopausal women between 18-45 years of age and BMI less than 42
Diagnosed with PCOS as defined by the Rotterdam criteria, which is a combination of any two of the following three criteria: 1) chronic oligo- or amenorrhea (<8 menstrual periods annually); 2) biochemical or clinical androgen excess; and 3) polycystic ovaries on ultrasonography -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; 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00703508). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.