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Human Ovarian Follicular Dynamics and Emergency Contraception

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00204451
First Posted: September 20, 2005
Last Update Posted: November 28, 2016
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.
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Roger Pierson, University of Saskatchewan
  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
Intervention Model: Parallel Assignment
Masking: None (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 Roger Pierson, 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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
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 ClinicalTrials.gov identifier (NCT number): 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)
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:
Responsible Party: Roger Pierson, Ph.D., FEAS, FCAHS, MS, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT00204451     History of Changes
Other Study ID Numbers: Bio 05-67
CIHR MOP 11489
First Submitted: September 12, 2005
First Posted: September 20, 2005
Last Update Posted: November 28, 2016
Last Verified: November 2016

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

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