Randomized Study of Decreased Hyperinsulinemia on the Ovulatory Response to Clomiphene Citrate in Women With Polycystic Ovary Syndrome
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00005104 |
|
Recruitment Status :
Completed
First Posted : April 7, 2000
Last Update Posted : June 24, 2005
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
OBJECTIVES:
I. Determine whether reduction of serum insulin levels by metformin increases ovulatory response to clomiphene citrate in women with polycystic ovary syndrome.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Polycystic Ovary Syndrome Hyperinsulinism | Drug: clomiphene citrate Drug: metformin | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 99 participants |
| Allocation: | Randomized |
| Masking: | Double |
| Primary Purpose: | Treatment |
| Study Start Date : | January 2000 |
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005104
| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294-3300 | |
| United States, Louisiana | |
| Louisiana State University School of Medicine | |
| Shreveport, Louisiana, United States, 71130-3932 | |
| United States, Missouri | |
| Washington University - St. Louis | |
| St. Louis, Missouri, United States, 63110 | |
| United States, Virginia | |
| University of Virginia | |
| Charlottesville, Virginia, United States, 22908 | |
| Medical College of Virginia School of Medicine | |
| Richmond, Virginia, United States, 23298-0230 | |
| Italy | |
| University Alma Mater | |
| Bologna, Italy, 40100 | |
| Study Chair: | William S. Evans | University of Virginia |
| ClinicalTrials.gov Identifier: | NCT00005104 History of Changes |
| Other Study ID Numbers: |
199/14915 UVA-HIC-7538 UVA-WSE026 |
| First Posted: | April 7, 2000 Key Record Dates |
| Last Update Posted: | June 24, 2005 |
| Last Verified: | December 2003 |
Keywords provided by National Center for Research Resources (NCRR):
|
endocrine disorders hyperinsulinism polycystic ovarian syndrome rare disease |
Additional relevant MeSH terms:
|
Hyperinsulinism Syndrome Polycystic Ovary Syndrome Disease Pathologic Processes Ovarian Cysts Cysts Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Gonadal Disorders Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases |
Citric Acid Clomiphene Enclomiphene Zuclomiphene Anticoagulants Calcium Chelating Agents Chelating Agents Sequestering Agents Molecular Mechanisms of Pharmacological Action Estrogen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Fertility Agents, Female Fertility Agents |