Ovarian Follicle Clinical Trial
Official title:
Mid-luteal Phase Synchronization of Ovarian Folliculogenesis in Women Protocol: WHIRL-07-2971
We hypothesize that administration of an aromatase inhibitor (AI) and hormonal contraceptives (HC) in the mid-luteal phase of the menstrual cycle will result in atresia of the follicles in the extant wave and cause synchronous re-emergence of a new follicular wave. We anticipate that this will provide us with information to facilitate the development of a new method for ovarian synchronization; a safer, more effective ovulation induction therapy; a new method for emergency contraception; and a greater understanding of human folliculogenesis.
Status | Completed |
Enrollment | 41 |
Est. completion date | September 2009 |
Est. primary completion date | September 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 35 Years |
Eligibility |
Inclusion Criteria: 1. female volunteers of childbearing potential; 2. are first time users of OC or have discontinued OC at least 2 months prior to study entry; 3. age between 18 and 35 years old; 4. normal body mass index (18-30); 5. has signed consent form; and 6. is in good health as confirmed by medical history, physical examination Exclusion Criteria: 1. a positive pregnancy test will automatically exclude the volunteer from participation in this study. 2. any contraindication for oral contraception use; 3. known hypersensitivity to Letrozole and co-administered medications; 4. irregular menstrual cycles; 5. ultrasonographic evidence of ovarian dysfunction, such as Polycystic Ovary Syndrome (PCOS); 6. history of pituitary tumor; 7. HIV, HBV, HCV infection; 8. vaginal infection; 9. abnormal ECG; 10. abnormal lab tests for blood profile, liver function and renal function; 11. uncontrolled diabetes and blood pressure; 12. pregnancy (suspected or diagnosed) or lactation; 13. history or suspicion of drug or alcohol abuse; 14. history of severe mental disorders; 15. participation in an investigational drug trial within the 30 days prior to selection; 16. exhibits a disorder that is a contraindication to steroid hormonal therapy, including, for example, the following conditions: - history of, or actual, thrombophlebitis or thromboembolic disorders. - history of, or actual, cerebrovascular disorders. - history of, or actual, myocardial infarction or coronary artery disease. - acute liver disease. - history of, or actual, benign or malignant liver tumors. - history of, or suspected, carcinoma of the breast. - known, or suspected, estrogen-dependent neoplasia. - undiagnosed abnormal vaginal bleeding. - any ocular lesion arising from ophthalmic vascular disease, such as partial or complete loss of vision or defect in visual field. |
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
Canada | Royal University Hospital | Saskatoon | Saskatchewan |
Lead Sponsor | Collaborator |
---|---|
University of Saskatchewan | Canadian Institutes of Health Research (CIHR) |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluate differences in the mechanisms of atresia, initiation of a new synchronous follicular wave, interval to follicle wave emergence, interval to emergence of dominant follicle, interval to menstruation, and endometrial thickness/pattern. | 24-28 days | ||
Secondary | To evaluate between treatment group differences in ultrasonographic image attributes of follicular structures that develop after administration of treatment. | ongoing |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01291004 -
A Study to Evaluate Ovarian Follicular Activity and Hormone Levels for DR-102 Compared to Two 28-Day Oral Contraceptives
|
Phase 1 |