Status:
COMPLETED
Administration of Oral Contraceptives at Different Times of the Follicular Phase of the Menstrual Cycle
Lead Sponsor:
University of Saskatchewan
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Contraception
Eligibility:
FEMALE
18-35 years
Phase:
NA
Brief 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 administra...
Detailed Description
This study is a single-centre, randomized, open-label, double-controlled protocol to study the patterns of ovarian follicular growth and regression in women administered 0.15mg desogestrel /0.03mg eth...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2002
Trial Type :
INTERVENTIONAL
End Date :
December 1 2002
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00204438
Start Date
February 1 2002
End Date
December 1 2002
Last Update
November 28 2016
Active Locations (1)
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1
Ob-Gyn Royal University Hospital
Saskatoon, Saskatchewan, Canada, S7N 0W8