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| ID | Type | Description | Link |
|---|---|---|---|
| CIHR MOP 11489 |
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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.75 levonorgestrel | Drug | |||
| 50 mg ethinyl estradiol/0.5 mg levonorgestrel | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| follicle development | ||
| ovulation status | ||
| peripheral blood pressure |
| Measure | Description | Time Frame |
|---|---|---|
| endometrial development |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Roger A Pierson, MS PhD | University of Saskatchewan | Principal Investigator |
| Salma T Hanna, MD PhD | University of Saskatchewan | Study Director |
| Olufemi A Olatunbosun, MD | University of Saskatchewan | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ob-Gyn Royal University Hospital | Saskatoon | Saskatchewan | S7N 0W8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12849799 | Background | 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. | |
| 12849812 | Background | 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. |
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