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| Name | Class |
|---|---|
| Shionogi | INDUSTRY |
| AEterna Zentaris | INDUSTRY |
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GnRH analogs are globally used for assisted reproduction in infertile patients. To date, in healthy female volunteers the pharmacokinetic and pharmacodynamic profiles of cetrorelix when administered in a single dose have been investigated in studies conducted using doses of 1, 3 and 5 mg. Studies performed in premenopausal female volunteers confirmed that cetrorelix rapidly suppresses luteinizing hormone (LH) and estradiol and shows dose-dependent prolongation of the duration of LH suppression. However, there have been few reports of studies of the relationship between the cetrorelix dosage and its effect on LH surge. In the present study, we investigated the effect of cetrorelix on LH surge when this drug was administered in single doses of 1, 2 and 3 mg.
To evaluate that effect on LH surge, we investigated the efficacy of cetrorelix in delaying the start of the LH surge in comparison with the control menstrual cycle when saline was administered, and also examined the mode of disappearance of pulsatile LH secretion during the cetrorelix administration menstrual cycle.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cetrorelix 1 mg | Experimental |
| |
| Cetrorelix 2 mg | Experimental |
| |
| Cetrorelix 3 mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cetrorelix | Drug | 1, 2 or 3mg, subcutaneouly dosed with single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Day of the LH surge | Saline administration menstrual cycle, cetrorelix administration menstrual cycle |
| Measure | Description | Time Frame |
|---|---|---|
| Serum LH concentrations | Saline administration menstrual cycle, cetrorelix administration menstrual cycle |
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Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kitasato University East Hospital | Sagamihara | Kanagawa | 228-8520 | Japan |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C062876 | cetrorelix |
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