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Randomized Study of Decreased Hyperinsulinemia on the Ovulatory Response to Clomiphene Citrate in Women With Polycystic Ovary Syndrome Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Randomized Study of Decreased Hyperinsulinemia on the Ovulatory Response to Clomiphene Citrate in Women With Polycystic Ovary Syndrome conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Randomized Study of Decreased Hyperinsulinemia on the Ovulatory Response to Clomiphene Citrate in Women With Polycystic Ovary Syndrome Clinical research trials and Randomized Study of Decreased Hyperinsulinemia on the Ovulatory Response to Clomiphene Citrate in Women With Polycystic Ovary Syndrome health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Randomized Study of Decreased Hyperinsulinemia on the Ovulatory Response to Clomiphene Citrate in Women With Polycystic Ovary Syndrome. Randomized Study of Decreased Hyperinsulinemia on the Ovulatory Response to Clomiphene Citrate in Women With Polycystic Ovary Syndrome Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Randomized Study of Decreased Hyperinsulinemia on the Ovulatory Response to Clomiphene Citrate in Women With Polycystic Ovary Syndrome clinical trial. Human subjects often get the best healthcare available for their Randomized Study of Decreased Hyperinsulinemia on the Ovulatory Response to Clomiphene Citrate in Women With Polycystic Ovary Syndrome condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "R" Clinical Trials Conditions > Randomized Study of Decreased Hyperinsulinemia on the Ovulatory Response to Clomiphene Citrate in Women With Polycystic Ovary Syndrome  Randomized Study of Decreased Hyperinsulinemia on the Ovulatory Response to Clomiphene Citrate in Women With Polycystic Ovary Syndrome
Randomized Study of Decreased Hyperinsulinemia on the Ovulatory Response to Clomiphene Citrate in Women With Polycystic Ovary Syndrome
For Condition: Polycystic Ovary Syndrome,Hyperinsulinism
Status: Completed
Sponsor(s): National Center for Research Resources (NCRR) , University of Virginia
Synopsis: OBJECTIVES: I. Determine whether reduction of serum insulin levels by metformin increases ovulatory response to clomiphene citrate in women with polycystic ovary syndrome.
Details: PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are randomized to one of two treatment arms. Patients receive oral metformin or oral placebo three times daily for 7 weeks. Patients remaining anovulatory by day 49 receive metformin or placebo plus escalating doses of oral clomiphene citrate daily for 5 consecutive days, beginning on days 50, 80, and 110. Following ovulation, treatment with clomiphene citrate and metformin or placebo continues until 6 ovulatory cycles occur, pregnancy occurs, or anovulation persists. Patients receiving the placebo arm who have not ovulated on the highest dose of clomiphene citrate may be crossed over to receive metformin after a 6 week washout.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control
Minimum Age/Maximum Age: 18 Years/40 Years
Genders: Female
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Patients with chronic anovulation due to polycystic ovary syndrome (PCOS) who have failed clomiphene citrate Must have oligoovulation and hyperandrogenemia --Prior/Concurrent Therapy-- Endocrine therapy: At least 2 months since prior clomiphene citrate Other: - At least 2 months since prior standard therapy (including over the counter drugs) - At least 2 months since prior investigational drugs - Prior multi/prenatal vitamins allowed --Patient Characteristics-- Hematopoietic: Hematocrit greater than 38% Hepatic: - Liver function normal - No clinically significant hepatic disease Renal: - No clinically significant renal disease - Creatinine less than 1.4 mg/dL - No proteinuria Cardiovascular: No clinically significant cardiac disease Pulmonary: No clinically significant pulmonary disease Hormonal: - Thyroid function normal - Prolactin normal - Estradiol normal - Fasting 17 alpha-hydroxy progesterone less than 200 ng/dL OR No late onset adrenal hyperplasia 21 alpha-hydroxylase deficiency Other: - Not pregnant - Negative pregnancy test - Male partner must have a normal semen analysis by WHO criteria - Must be in acceptable health by interview, medical history, physical exam, and laboratory tests - No diabetes mellitus - No clinically significant neurologic, psychiatric, infectious, neoplastic, or metabolic disease - No clinically significant malignant disease except nonmelanomatous skin cancer - At least 1 year since any prior drug abuse or alcoholism
Total Enrollment: 99
Location and Contact Information:
Overall Study Official:
WilliamEvans, Study Chair, University of Virginia
Washington University - St. Louis
St. Louis, Missouri, 63110
United States
Medical College of Virginia School of Medicine
Richmond, Virginia, 23298-0230
United States
University of Alabama at Birmingham
Birmingham, Alabama, 35294-3300
United States
Louisiana State University School of Medicine
Shreveport, Louisiana, 71130-3932
United States
University of Virginia
Charlottesville, Virginia, 22908
United States
University Alma Mater
Bologna, , 40100
Italy
Additional Information:
Study ID Numbers: 199/14915; UVA-HIC-7538,UVA-WSE026
Study Start Date: January 2000
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005104
Other Hyperinsulinism Studies:
1. Randomized Study of the Effect of Decreased Hyperinsulinemia on the Ovulatory Response to Clomiphene Citrate in Obese Women With Polycystic Ovary Syndrome
2. Randomized Study of Decreased Hyperinsulinemia on the Ovulatory Response to Clomiphene Citrate in Women With Polycystic Ovary Syndrome
3. Phase II Study of the Effect of Leuprolide Acetate and Spironolactone on Insulin Resistance in Hyperandrogenic Women with Polycystic Ovarian Disease or Hyperandrogenism Insulin Resistance Acanthosis Nigricans Syndrome
4. Treatment of Infertility in Women With Polycystic Ovary Syndrome
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Randomized Study of Decreased Hyperinsulinemia on the Ovulatory Response to Clomiphene Citrate in Women With Polycystic Ovary Syndrome
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