Human Ovarian Follicular Dynamics and Emergency Contraception

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00204451
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : November 28, 2016
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Roger Pierson, University of Saskatchewan

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 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.

Condition or disease Intervention/treatment Phase
Contraception Drug: 0.75 levonorgestrel Drug: 50 mg ethinyl estradiol/0.5 mg levonorgestrel Phase 4

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 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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Human Ovarian Follicular Dynamics and Emergency Contraception
Study Start Date : July 2005
Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Primary Outcome Measures :
  1. follicle development
  2. ovulation status
  3. peripheral blood pressure

Secondary Outcome Measures :
  1. endometrial development

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00204451

Canada, Saskatchewan
Ob-Gyn Royal University Hospital
Saskatoon, Saskatchewan, Canada, S7N 0W8
Sponsors and Collaborators
University of Saskatchewan
Canadian Institutes of Health Research (CIHR)
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

Responsible Party: Roger Pierson, Ph.D., FEAS, FCAHS, MS, University of Saskatchewan Identifier: NCT00204451     History of Changes
Other Study ID Numbers: Bio 05-67
CIHR MOP 11489
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: November 28, 2016
Last Verified: November 2016

Keywords provided by Roger Pierson, University of Saskatchewan:
emergency contraception
blood pressure
Fertility Control
Inhibition of fertilization

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes
Ethinyl Estradiol
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Contraceptives, Oral, Synthetic
Contraceptives, Oral