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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
We hypothesize that administration of an aromatase inhibitor (AI) and hormonal contraceptives (HC) in the mid-luteal phase of the menstrual cycle will result in atresia of the follicles in the extant wave and cause synchronous re-emergence of a new follicular wave. We anticipate that this will provide us with information to facilitate the development of a new method for ovarian synchronization; a safer, more effective ovulation induction therapy; a new method for emergency contraception; and a greater understanding of human folliculogenesis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Contraceptive | Experimental |
| |
| Contraceptive Ring | Experimental |
| |
| Aromatase Inhibitors | Experimental |
| |
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Marvelon | Drug | oral contraceptive |
| |
| Nuvaring |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate differences in the mechanisms of atresia, initiation of a new synchronous follicular wave, interval to follicle wave emergence, interval to emergence of dominant follicle, interval to menstruation, and endometrial thickness/pattern. | 24-28 days |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate between treatment group differences in ultrasonographic image attributes of follicular structures that develop after administration of treatment. | ongoing |
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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;
known hypersensitivity to Letrozole and co-administered medications;
irregular menstrual cycles;
ultrasonographic evidence of ovarian dysfunction, such as Polycystic Ovary Syndrome (PCOS);
history of pituitary tumor;
HIV, HBV, HCV infection;
vaginal infection;
abnormal ECG;
abnormal lab tests for blood profile, liver function and renal function;
uncontrolled diabetes and blood pressure;
pregnancy (suspected or diagnosed) or lactation;
history or suspicion of drug or alcohol abuse;
history of severe mental disorders;
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 | University of Saskatchewan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal University Hospital | Saskatoon | Saskatchewan | S7N 0W8 | Canada |
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| ID | Term |
|---|---|
| D017135 | Desogestrel |
| C516519 | NuvaRing |
| D000077289 | Letrozole |
| ID | Term |
|---|---|
| D009652 | Norpregnenes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 | Steroids |
| D000072473 |
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| Drug |
contraceptive vaginal ring |
|
| Letrozole | Drug | Aromatase Inhibitors |
|
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |