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Sponsored by: |
Organon |
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Information provided by: | Organon |
ClinicalTrials.gov Identifier: | NCT00598208 |
The primary objective of this trial is to investigate the dose -response relationship of a single injection of Org 38286 to initiate multifollicular growth for the first seven days in a controlled ovarian hyperstimulation (COH) protocol for IVF or ICSI.
Condition | Intervention | Phase |
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Fertilization |
Drug: corifollitropin alfa Drug: Follitropin beta injection |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2, Open Label, Randomized Trial to Investigate the Dose-Response Relationship of a Single Injection of Org 36286 (Corifollitropin Alfa) to Initiate Multiple Follicular Growth in a Controlled Ovarian Hyperstimulation Protocol for IVF or ICSI. |
Enrollment: | 325 |
Study Start Date: | May 2003 |
Study Completion Date: | May 2004 |
Primary Completion Date: | May 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
60 µg Org 36286 (corifollitropin alfa)
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Drug: corifollitropin alfa
On Cycle Day 2, a single injection of 60 μg, 120 μg, or 180 μg Org 36286 was administered. One week later (Treatment Day 8), treatment was continued with a fixed daily subcutaneous (SC) dose of 150 IU Puregon® up to and including the Day of hCG. Orgalutran® (0.25 mg) was administered once daily SC starting on Treatment Day 5 and up to and including the Day of hCG. The maximum total treatment duration was 19 days.
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2: Experimental
120 µg Org 36286 (corifollitropin alfa)
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Drug: corifollitropin alfa
On Cycle Day 2, a single injection of 60 μg, 120 μg, or 180 μg Org 36286 was administered. One week later (Treatment Day 8), treatment was continued with a fixed daily subcutaneous (SC) dose of 150 IU Puregon® up to and including the Day of hCG. Orgalutran® (0.25 mg) was administered once daily SC starting on Treatment Day 5 and up to and including the Day of hCG. The maximum total treatment duration was 19 days.
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3: Experimental
180 µg Org 36286 (corifollitropin alfa)
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Drug: corifollitropin alfa
On Cycle Day 2, a single injection of 60 μg, 120 μg, or 180 μg Org 36286 was administered. One week later (Treatment Day 8), treatment was continued with a fixed daily subcutaneous (SC) dose of 150 IU Puregon® up to and including the Day of hCG. Orgalutran® (0.25 mg) was administered once daily SC starting on Treatment Day 5 and up to and including the Day of hCG. The maximum total treatment duration was 19 days.
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4: Active Comparator
Follitropin beta injection
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Drug: Follitropin beta injection
Starting on Cycle Day 2, a fixed daily dose of 150 IU Puregon® SC was administered for the entire stimulation period up to and including the Day of hCG. Orgalutran® (0.25 mg) was administered once daily SC starting on Treatment Day 5 and given up to and including the day of hCG. The maximum total treatment duration was 19 days.
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Ages Eligible for Study: | 18 Years to 39 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Organon, part of Schering-Plough Corporation ( Study Director ) |
Study ID Numbers: | 38826 |
Study First Received: | January 10, 2008 |
Last Updated: | July 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00598208 History of Changes |
Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products; Denmark: Danish Medicines Agency; Finland: National Agency for Medicines; Germany: Federal Institute for Drugs and Medical Devices; Norway: Norwegian Medicines Agency; Sweden: Medical Products Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
In-vitro fertilization |
Ganirelix Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Follicle Stimulating Hormone |
Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Pharmacologic Actions Follicle Stimulating Hormone |