Administration of Oral Contraceptives at Different Times of the Follicular Phase of the Menstrual Cycle

• Status: Completed
• Trial end date: 2002-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

We hypothesize that administration of OCs at varying follicular diameters will provide an appropriate model for the study of follicular atresia in women. Clinically, we hypothesize that the administration on OCs at different stages of the follicular phase will result in markedly different patterns of follicular development and/or atresia.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Saskatchewan
• Collaborator: Canadian Institutes of Health Research (CIHR)
• Treatments: Contraceptive Agents; Contraceptives, Oral; Desogestrel; Estradiol; Ethinyl Estradiol

Criteria

Inclusion Criteria:

• Female volunteers of childbearing potential;

• Are first time users of OCs or have discontinued OCs at least 1 month prior to study entry;

• Aged between 18 and 35 years (extremes included);

• Normal body mass index (18-38);

• Has signed informed consent form;

• Is in good health as confirmed by medical history, physical examination, and PAP smear or colposcopy within the past 12 months with normal results.

Exclusion Criteria:

• Any contraindication for oral contraceptive use;

• Irregular menstrual cycles

• Ultrasonographic evidence of ovarian dysfunction, such as Polycystic Ovary Syndrome (PCOS);

• Pregnancy (suspected or diagnosed) or lactation;

• Use of disallowed concomitant therapy;

• History or suspicion of drug or alcohol abuse;

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

• 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;

• Known, or suspected, carcinoma of the breast;

• Known, or suspected, estrogen-dependent neoplasia;

• Undiagnosed abnormal vaginal bleeding;

• Any ocular lesion arising from opthalmic vascular disease, such as partial or complete loss of vision or defect in visual fields.

• Latex allergy.