Status:
COMPLETED
Human Ovarian Follicular Dynamics and Emergency Contraception
Lead Sponsor:
University of Saskatchewan
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Contraception
Eligibility:
FEMALE
18-40 years
Phase:
PHASE4
Brief Summary
The researchers hypothesize that emergency contraception (EC) will initiate the changes associated with atresia or ovulatory failure at all stages of follicular development and that the image attribut...
Detailed Description
This study is a single-center, randomized, open-label, double-controlled protocol to study the pattern of ovarian follicular growth and regression in two groups of women. The first group will use Plan...
Eligibility Criteria
Inclusion
- Female volunteers of childbearing potential;
- Are first time users of oral contraception (OC) or have discontinued OC at least 1 month prior to study entry;
- Age between 18 and 40 years old;
- Normal body mass index (18-38);
- Has signed informed consent form; and
- Is in good health as confirmed by medical history, physical examination.
Exclusion
- A positive pregnancy test will automatically exclude the volunteer from participation in this study.
- Any contraindication for oral contraception use;
- Irregular menstrual cycles;
- Ultrasonographic evidence of ovarian dysfunction, such as polycystic ovary syndrome (PCOS);
- Pregnancy (suspected or diagnosed) or lactation;
- 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.
- 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.
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
End Date :
June 1 2006
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00204451
Start Date
July 1 2005
End Date
June 1 2006
Last Update
November 28 2016
Active Locations (1)
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1
Ob-Gyn Royal University Hospital
Saskatoon, Saskatchewan, Canada, S7N 0W8