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.

Study Type: Interventional

Study Design: Health Services Research, Randomized, Open Label, Active Control, Single Group Assignment

Intervention(s) in this Clinical Trial

• Drug: Marvelon
  • oral contraceptive
• Drug: Evra Patch
  • contraceptive patch
• Drug: Nuvaring
  • contraceptive vaginal ring
• Drug: Letrozole
  • Aromatase Inhibitors

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Oral Contraceptive
• Experimental: Contraceptive Patch
• Experimental: Contraceptive Ring
• Experimental: Aromatase Inhibitors
• No Intervention: Control

Primary Measures

• 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.
  • Time Frame: 24-28 days
    

Secondary Measures

• To evaluate between treatment group differences in ultrasonographic image attributes of follicular structures that develop after administration of treatment.
  • Time Frame: ongoing
    

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.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 35 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: University of Saskatchewan

Overall Clinical Trial Officials and Contacts

Roger A Pierson Principal Investigator University of Saskatchewan  

Overall Contact: Terri Bloski 306-966-7873 bloski@erato.usask.ca

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00565240

Study ID Number: WHIRL-07-2971

ClinicalTrials.gov Identifier: NCT00565240

Health Authority: United States: Institutional Review Board