Luveris®(Lutropin Alfa for Injection) in Women With Hypogonadotropic Hypogonadism (LH <1.2 IU/L)
| Status: | Archived |
|---|---|
| Conditions: | Endocrine |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
A Phase IV , Multicenter, Randomized, Double-blinded, Clinical Trial to Confirm the Efficacy of the 75 IU Dose of Luveris® vs. Placebo When Administered With Follitropin Alfa for Induction of Follicular Development and Pregnancy in Hypogonadotropic Hypogonadal Women With Profound LH Deficiency, as Defined by a Baseline LH Level <1.2 IU/L.
To confirm the efficacy of the 75 IU dose of Luveris® compared to placebo when administered
concomitantly with follitropin alfa for induction of clinical pregnancy in women with
hypogonadotropic hypogonadism and profound LH deficiency (LH <1.2 IU/L), and to study the
efficacy of a lower dose (25 IU) of Luveris® compared to placebo when administered
concomitantly with follitropin alfa for induction of follicular development in women with
hypogonadotropic hypogonadism and profound LH deficiency (LH <1.2 IU/L).
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