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Randomized Study of Decreased Hyperinsulinemia on the Ovulatory Response to Clomiphene Citrate in Women With Polycystic Ovary Syndrome Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician 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 website devoted 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 medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as 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 permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated 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. Subjects often receive the most expert healthcare possible for their Randomized Study of Decreased Hyperinsulinemia on the Ovulatory Response to Clomiphene Citrate in Women With Polycystic Ovary Syndrome condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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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. Lipoprotein Metabolism in Hypertensive African-Americans
3. Central Obesity and Disease Risk in Japanese Americans
4. Short Term Study of Recombinant Human Insulin-like Growth Factor I in Children with Hyperinsulinism
5. Phase II Long Term, Randomized Study of Recombinant Human Insulin-like Growth Factor I in Children with Hyperinsulinism
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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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