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Sponsored by: |
Organon |
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Information provided by: | Organon |
ClinicalTrials.gov Identifier: | NCT00702585 |
The objectives of this trial were to investigate the feasibility and the optimal dose of a single administration of Org 36286 to induce monofollicular ovulation in women with WHO Group II anovulatory infertility and to assess the safety (including the absence of antibody formation) of Org 36286.
Condition | Intervention | Phase |
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Infertility |
Drug: Corifollitropin Alfa Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Phase II, Randomized, Double-Blind, Placebo-Controlled, Comparative Trial to Investigate the Optimal Dose of a Single Administration of Org 36286 (Corifollitropin Alfa) to Induce Monofollicular Ovulation in Women With WHO Group II Anovulatory Infertility |
Enrollment: | 55 |
Study Start Date: | August 2001 |
Study Completion Date: | October 2002 |
Primary Completion Date: | October 2002 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm 1: Experimental
7.5 µg Org 36286 (corifollitropin alfa)
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Drug: Corifollitropin Alfa
single subcutaneous injection of 7.5, 15, 30, or 60 ug Org 36286. The Org 36286 injection was given on the day of the onset of a spontaneous or progestagen induced withdrawal bleeding or one to two days later
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Arm 2: Experimental
15 µg Org 36286 (corifollitropin alfa)
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Drug: Corifollitropin Alfa
single subcutaneous injection of 7.5, 15, 30, or 60 ug Org 36286. The Org 36286 injection was given on the day of the onset of a spontaneous or progestagen induced withdrawal bleeding or one to two days later
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Arm 3: Experimental
30 µg Org 36286 (corifollitropin alfa)
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Drug: Corifollitropin Alfa
single subcutaneous injection of 7.5, 15, 30, or 60 ug Org 36286. The Org 36286 injection was given on the day of the onset of a spontaneous or progestagen induced withdrawal bleeding or one to two days later
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Arm 4: Experimental
60 µg Org 36286 (corifollitropin alfa)
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Drug: Corifollitropin Alfa
single subcutaneous injection of 7.5, 15, 30, or 60 ug Org 36286. The Org 36286 injection was given on the day of the onset of a spontaneous or progestagen induced withdrawal bleeding or one to two days later
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Arm 5: Placebo Comparator
Placebo
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Drug: Placebo
single subcutaneous injection of placebo. The placebo injection was given on the day of the onset of a spontaneous or progestagen induced withdrawal bleeding or one to two days later
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This was a phase II, randomized, double-blind, placebo controlled, comparative trial to investigate the optimal dose of a single administration of Org 36286 to induce monofollicular ovulation in women with WHO Group II anovulatory infertility.
Treatment injection was given on Day 1-3 after the onset of a spontaneous or progestagen induced withdrawal bleeding. After injection ultrasound monitoring and sampling for serum hormones were done on treatment Days 3, 5, and daily from Day 7 to 21 or until a urinary Luteinizing hormone (LH) peak was detected. From treatment Day 7 the urinary LH response was assessed to detect the preovulatory LH peak. In case of hyperstimulation, production of endogenous gonadotropins could be suppressed by giving daily injections of GnRH antagonist.
Post-treatment assessments were done in the third week after the urinary LH peak. If no LH peak was detected, posttreatment assessments were performed four to five weeks after Org 36286 or placebo injection.
Ages Eligible for Study: | 18 Years to 39 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | NV Organon, part of Schering-Plough Corporation ( Study Director ) |
Study ID Numbers: | 38805 |
Study First Received: | June 18, 2008 |
Last Updated: | June 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00702585 |
Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Ovulation Induction Pharmacological effects of drugs Hormones Hormone substitutes and Hormone Antagonists |
Pharmacological Actions Randomized Multi-center Multi-national |
Genital Diseases, Female Infertility Genital Diseases, Male |