search
Back to results

Human Ovarian Follicular Dynamics and Emergency Contraception

Primary Purpose

Contraception

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
0.75 levonorgestrel
50 mg ethinyl estradiol/0.5 mg levonorgestrel
Sponsored by
University of Saskatchewan
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Contraception focused on measuring emergency contraception, follicle, ovulation, blood pressure, Fertility Control, Inhibition of fertilization

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Female volunteers of childbearing potential; Are first time users of oral contraception (OC) or have discontinued OC at least 1 month prior to study entry; Age between 18 and 40 years old; Normal body mass index (18-38); Has signed informed consent form; and Is in good health as confirmed by medical history, physical examination. Exclusion Criteria: A positive pregnancy test will automatically exclude the volunteer from participation in this study. Any contraindication for oral contraception use; Irregular menstrual cycles; Ultrasonographic evidence of ovarian dysfunction, such as polycystic ovary syndrome (PCOS); Pregnancy (suspected or diagnosed) or lactation; History or suspicion of drug or alcohol abuse; Participation in an investigational drug trial within the 30 days prior to selection; 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.

Sites / Locations

  • Ob-Gyn Royal University Hospital

Outcomes

Primary Outcome Measures

follicle development
ovulation status
peripheral blood pressure

Secondary Outcome Measures

endometrial development

Full Information

First Posted
September 12, 2005
Last Updated
November 23, 2016
Sponsor
University of Saskatchewan
Collaborators
Canadian Institutes of Health Research (CIHR)
search

1. Study Identification

Unique Protocol Identification Number
NCT00204451
Brief Title
Human Ovarian Follicular Dynamics and Emergency Contraception
Official Title
Human Ovarian Follicular Dynamics and Emergency Contraception
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2006 (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Saskatchewan
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contraception
Keywords
emergency contraception, follicle, ovulation, blood pressure, Fertility Control, Inhibition of fertilization

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
0.75 levonorgestrel
Intervention Type
Drug
Intervention Name(s)
50 mg ethinyl estradiol/0.5 mg levonorgestrel
Primary Outcome Measure Information:
Title
follicle development
Title
ovulation status
Title
peripheral blood pressure
Secondary Outcome Measure Information:
Title
endometrial development

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Female volunteers of childbearing potential; Are first time users of oral contraception (OC) or have discontinued OC at least 1 month prior to study entry; Age between 18 and 40 years old; Normal body mass index (18-38); Has signed informed consent form; and Is in good health as confirmed by medical history, physical examination. Exclusion Criteria: A positive pregnancy test will automatically exclude the volunteer from participation in this study. Any contraindication for oral contraception use; Irregular menstrual cycles; Ultrasonographic evidence of ovarian dysfunction, such as polycystic ovary syndrome (PCOS); Pregnancy (suspected or diagnosed) or lactation; History or suspicion of drug or alcohol abuse; Participation in an investigational drug trial within the 30 days prior to selection; 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger A Pierson, MS PhD
Organizational Affiliation
University of Saskatchewan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Salma T Hanna, MD PhD
Organizational Affiliation
University of Saskatchewan
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Olufemi A Olatunbosun, MD
Organizational Affiliation
University of Saskatchewan
Official's Role
Study Chair
Facility Information:
Facility Name
Ob-Gyn Royal University Hospital
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
12849799
Citation
Pierson RA, Archer DF, Moreau M, Shangold GA, Fisher AC, Creasy GW. Ortho Evra/Evra versus oral contraceptives: follicular development and ovulation in normal cycles and after an intentional dosing error. Fertil Steril. 2003 Jul;80(1):34-42. doi: 10.1016/s0015-0282(03)00556-9.
Results Reference
background
PubMed Identifier
12849812
Citation
Baerwald AR, Adams GP, Pierson RA. A new model for ovarian follicular development during the human menstrual cycle. Fertil Steril. 2003 Jul;80(1):116-22. doi: 10.1016/s0015-0282(03)00544-2.
Results Reference
background

Learn more about this trial

Human Ovarian Follicular Dynamics and Emergency Contraception

We'll reach out to this number within 24 hrs