Clinical trial NCT00204451: Human Ovarian Follicular Dynamics and Emergency Contraception
Official title: Human Ovarian Follicular Dynamics and Emergency Contraception
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Contraception
Keywords: emergency contraception
follicle
ovulation
blood pressure
Fertility Control
Inhibition of fertilization
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2005-09-20
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: follicle development
measure: ovulation status
measure: peripheral blood pressure
Secondary outcomes:
measure: endometrial development
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: Ob-Gyn Royal University Hospital
state: Saskatchewan
Study officials:
affiliation: University of Saskatchewan
name: Roger A Pierson, MS PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Saskatchewan
name: Salma T Hanna, MD PhD
role: STUDY_DIRECTOR
affiliation: University of Saskatchewan
name: Olufemi A Olatunbosun, MD
role: STUDY_CHAIR
References:
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.
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.