Human Ovarian Follicular Dynamics and Emergency Contraception

Contraception Clinical Trial

Official title:

Human Ovarian Follicular Dynamics and Emergency Contraception

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00204451
• Other study ID #: Bio 05-67
• Secondary ID: CIHR MOP 11489
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: November 23, 2016
• Start date: July 2005
• Est. completion date: June 2006

Study information

• Verified date: November 2016
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaCanada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Contraception
• Emergencies

Intervention

Drug:
• 0.75 levonorgestrel

• 50 mg ethinyl estradiol/0.5 mg levonorgestrel

Locations

Country	Name	City	State
Canada	Ob-Gyn Royal University Hospital	Saskatoon	Saskatchewan

Sponsors (2)

Lead Sponsor	Collaborator
University of Saskatchewan	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	follicle development
Primary	ovulation status
Primary	peripheral blood pressure
Secondary	endometrial development