Clinical trial · Interventional
Randomized Study of Decreased Hyperinsulinemia on the Ovulatory Response to Clomiphene Citrate in Women With Polycystic Ovary Syndrome
NCT00005104CI-TRIAL-00000087completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
OBJECTIVES: I. Determine whether reduction of serum insulin levels by metformin increases ovulatory response to clomiphene citrate in women with polycystic ovary syndrome.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hyperinsulinism | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| clomiphene citrate | Drug | — | UNRESOLVED |
| metformin | Drug | Metformin | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.