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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
  Purpose

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 Intervention Phase
Contraception
Drug: 0.75 levonorgestrel
Drug: 50 mg ethinyl estradiol/0.5 mg levonorgestrel
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Human Ovarian Follicular Dynamics and Emergency Contraception

Resource links provided by NLM:


Further study details as provided by University of Saskatchewan:

Primary Outcome Measures:
  • follicle development
  • ovulation status
  • peripheral blood pressure

Secondary Outcome Measures:
  • endometrial development

Estimated Enrollment: 40
Study Start Date: July 2005
Estimated Study Completion Date: June 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00204451

Locations
Canada, Saskatchewan
Ob-Gyn Royal University Hospital
Saskatoon, Saskatchewan, Canada, S7N 0W8
Sponsors and Collaborators
University of Saskatchewan
Canadian Institutes of Health Research (CIHR)
Women's Health Imaging Research Laboratory
Investigators
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
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00204451     History of Changes
Other Study ID Numbers: Bio 05-67, CIHR MOP 11489
Study First Received: September 12, 2005
Last Updated: October 2, 2006
Health Authority: Canada: Health Canada
Canada: Ethics Review Committee

Keywords provided by University of Saskatchewan:
emergency contraception
follicle
ovulation
blood pressure
Emergency Contraception
Fertility Control
Inhibition of fertilization

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

ClinicalTrials.gov processed this record on November 20, 2014