Aromatase Inhibitor Effects on Ovarian Function During the Follicular and Early Luteal Phase in Women

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

A single center, open label randomized clinical trial designed to examine ovarian follicular dynamics following attempted atresia induction during the late follicular and early luteal phase of the menstrual cycle using an aromatase inhibitor.

We hypothesize that administration of an aromatase inhibitor (AI) at biologically important times of the natural menstrual cycle will cause ovulatory failure in women with preovulatory follicles and failure of luteogenesis in women who have recently ovulated. It is proposed that atresia of the dominant follicle and formation of anovulatory structures will be associated with arrested endometrial development and a shortened interval to menstrual bleeding (3 days). We anticipate that this will provide us with information to facilitate the development of a new method for emergency contraception and a greater understanding of human folliculogenesis.

The rationale for the proposed research project is based on the ovarian synchronization concepts developed and documented in the bovine model in the Reproductive Science and Medicine Research group at the University of Saskatchewan combined with novel human ovarian wave concepts of folliculogenesis first elucidated in the Women's Health Imaging Research Laboratory (WHIRL) in the Department of Obstetrics, Gynecology and Reproductive Sciences.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Saskatchewan
• Collaborator: Canadian Institutes of Health Research (CIHR)
• Treatments: Aromatase Inhibitors; Letrozole

Criteria

Inclusion Criteria:

• Female subjects of childbearing potential with normal reproductive function;

• Women between 18 and 35 years of age;

• Normal Body Mass Index (18-30);

• Are naïve to OC or have discontinued OC at least 2 months prior to study entry;

• Subject has signed the informed consent form;

• Subject is in good general health as confirmed by medical history and physical examination

Exclusion Criteria:

• Irregular menstrual cycles;

• Any contraindication for oral contraception use;

• Known hypersensitivity to Letrozole and co-administered medications;

• Evidence of Polycystic Ovary Syndrome (PCOS) or Endometriosis;

• History of pituitary tumor;

• Pregnancy (suspected or diagnosed) or lactation;

• HIV, HBV, HCV infection;

• Vaginal infection;

• Abnormal ECG;

• Abnormal lab tests for blood profile, liver function and renal function;

• Uncontrolled diabetes and blood pressure;

• History or suspicion of alcohol or drug abuse;

• History of severe mental disorders;

• Participation in an investigational drug trial in the 30 days prior to selection;

• A subject who 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 arterial disease.

• Active liver disease or history of/or actual benign or malignant liver tumors.

• Known or suspected carcinoma of the breast.

• Known or suspected oestrogen-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 fields.

• Smokes.