Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
University of Saskatchewan Canadian Institutes of Health Research (CIHR) Women's Health Imaging Research Laboratory |
---|---|
Information provided by: | University of Saskatchewan |
ClinicalTrials.gov Identifier: | NCT00204451 |
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 IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Human Ovarian Follicular Dynamics and Emergency Contraception |
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.
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Exhibits a disorder that is a contraindication to steroid hormonal therapy, including, for example, the following conditions:
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 |
Study ID Numbers: | Bio 05-67, CIHR MOP 11489 |
Study First Received: | September 12, 2005 |
Last Updated: | October 2, 2006 |
ClinicalTrials.gov Identifier: | NCT00204451 |
Health Authority: | Canada: Health Canada; Canada: Ethics Review Committee |
emergency contraception follicle ovulation blood pressure |
Emergency Contraception Fertility Control Inhibition of fertilization |
Infertility Levonorgestrel Estradiol 3-benzoate Estradiol valerate Ethinyl Estradiol |
Emergencies Estradiol 17 beta-cypionate Polyestradiol phosphate Estradiol |
Disease Attributes Estrogens Contraceptive Agents Physiological Effects of Drugs Contraceptives, Oral Hormones, Hormone Substitutes, and Hormone Antagonists Contraceptive Agents, Female |
Reproductive Control Agents Hormones Pharmacologic Actions Pathologic Processes Therapeutic Uses Contraceptives, Oral, Synthetic |