Human Ovarian Follicular Dynamics and Emergency Contraception
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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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Human Ovarian Follicular Dynamics and Emergency Contraception |
- follicle development
- ovulation status
- peripheral blood pressure
- endometrial development
| Estimated Enrollment: | 40 |
| Study Start Date: | July 2005 |
| Estimated Study Completion Date: | June 2006 |
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| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations| Canada, Saskatchewan | |
| Ob-Gyn Royal University Hospital | |
| Saskatoon, Saskatchewan, Canada, S7N 0W8 | |
| 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:
| ClinicalTrials.gov Identifier: | NCT00204451 History of Changes |
| Other Study ID Numbers: | Bio 05-67, CIHR MOP 11489 |
| Study First Received: | September 12, 2005 |
| Last Updated: | October 2, 2006 |
| Health Authority: | Canada: Health Canada Canada: Ethics Review Committee |
Keywords provided by University of Saskatchewan:
|
emergency contraception follicle ovulation blood pressure |
Emergency Contraception 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 Pharmacologic Actions Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Therapeutic Uses Contraceptives, Oral, Synthetic Contraceptives, Oral |
ClinicalTrials.gov processed this record on June 18, 2013