Human Ovarian Follicular Dynamics and Emergency Contraception

November 23, 2016 updated by: Roger Pierson, University of Saskatchewan
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
        • Ob-Gyn Royal University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
follicle development
ovulation status
peripheral blood pressure

Secondary Outcome Measures

Outcome Measure
endometrial development

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Saskatchewan

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

  • Study Director: Salma T Hanna, MD PhD, University of Saskatchewan
  • Study Chair: Olufemi A Olatunbosun, MD, University of Saskatchewan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Study Completion

June 1, 2006

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 19, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

November 28, 2016

Last Update Submitted That Met QC Criteria

November 23, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bio 05-67
  • CIHR MOP 11489

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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