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Human Ovarian Follicular Dynamics and Emergency Contraception

This study has been completed.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Women's Health Imaging Research Laboratory
Information provided by:
University of Saskatchewan
ClinicalTrials.gov Identifier:
NCT00204451
First received: September 12, 2005
Last updated: October 2, 2006
Last verified: October 2006

September 12, 2005
October 2, 2006
July 2005
Not Provided
  • follicle development
  • ovulation status
  • peripheral blood pressure
Same as current
Complete list of historical versions of study NCT00204451 on ClinicalTrials.gov Archive Site
endometrial development
Same as current
Not Provided
Not Provided
 
Human Ovarian Follicular Dynamics and Emergency Contraception
Human Ovarian Follicular Dynamics and Emergency Contraception

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 attributes associated with atresia will be similar regardless of the diameter of the dominant follicle when ovarian suppression is initiated. Second, changes associated with atresia may be observed, but ovulation of the dominant follicle is unimpeded.

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 B, which is a progesterone only OC containing 0.75 levonorgestrel. The second group of women will use the Yuzpe regimen, which uses 50 mg ethinyl estradiol/0.5 mg levonorgestrel pills at different stages of the menstrual follicular cycle.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Contraception
  • Drug: 0.75 levonorgestrel
  • Drug: 50 mg ethinyl estradiol/0.5 mg levonorgestrel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
June 2006
Not Provided

Inclusion Criteria:

  1. Female volunteers of childbearing potential;
  2. Are first time users of oral contraception (OC) or have discontinued OC at least 1 month prior to study entry;
  3. Age between 18 and 40 years old;
  4. Normal body mass index (18-38);
  5. Has signed informed 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. Irregular menstrual cycles;
  4. Ultrasonographic evidence of ovarian dysfunction, such as polycystic ovary syndrome (PCOS);
  5. Pregnancy (suspected or diagnosed) or lactation;
  6. History or suspicion of drug or alcohol abuse;
  7. Participation in an investigational drug trial within the 30 days prior to selection;
  8. 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.
Female
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00204451
Bio 05-67, CIHR MOP 11489
Not Provided
Not Provided
University of Saskatchewan
  • Canadian Institutes of Health Research (CIHR)
  • Women's Health Imaging Research Laboratory
Principal Investigator: Roger A Pierson, MS PhD University of Saskatchewan
Study Director: Salma T Hanna, MD PhD University of Saskatchewan
Study Chair: Olufemi A Olatunbosun, MD University of Saskatchewan
University of Saskatchewan
October 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP