Bravelle (Urofollitropin) - Summary

BRAVELLE SUMMARY

Bravelle™ is a product containing a highly purified preparation of human follicle stimulating hormone (hFSH) extracted from the urine of postmenopausal women. Human FSH consists of two non-covalently linked glycoproteins designated as the (alpha) and (beta) subunits. The (alpha) subunit has 92 amino acids of which two are modified by attachment of carbohydrates. The (beta) subunit has 111 amino acids of which two are modified by attachment of carbohydrates.

Bravelle™ administered SC or IM in conjunction with hCG, is indicated for ovulation induction in patients who have previously received pituitary suppression.

Bravelle™ administered SC in conjunction with hCG is indicated for multiple follicular development (controlled ovarian stimulation) during ART cycles in patients who have previously received pituitary suppression.

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BRAVELLE NEWS HIGHLIGHTS

Published Studies Related to Bravelle (Urofollitropin)

Endometrin for luteal phase support in a randomized, controlled, open-label, prospective in-vitro fertilization trial using a combination of Menopur and Bravelle for controlled ovarian hyperstimulation. [2008.03.25]

Evaluation of mixed protocols with Bravelle (human-derived FSH) and Repronex (hMG) to assess clinical efficacy (EMBRACE) in women undergoing in vitro fertilization. [2004.08]

Highly purified human-derived follicle-stimulating hormone (Bravelle) has equivalent efficacy to follitropin-beta (Follistim) in infertile women undergoing in vitro fertilization. [2003.10.03]

Comparison of the efficacy and safety of a highly purified human follicle-stimulating hormone (Bravelle) and recombinant follitropin-beta for in vitro fertilization: a prospective, randomized study. [2002.06]

Mixed protocols: multiple ratios of FSH and LH bioactivity using highly purified, human-derived FSH (BRAVELLE) and highly purified hMG (MENOPUR) are unaltered by mixing together in the same syringe. [2005.11.09]

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Clinical Trials Related to Bravelle (Urofollitropin)

Investigation of a Long Acting Follicle Stimulating Hormone in Women Undergoing Assisted Reproductive Technology (ART) [Active, not recruiting]

Clinical Efficacy and Tolerability of Two FSH Preparations (Human FSH Versus rFSH - Follitropin Alpha) in Women Undergoing IVF [Completed]

Efficacy and Tolerability of Human FSH Versus Recombinant FSH (Follitropin Alpha) in ICSI. [Completed]

Investigate Dose of Org 36286 to Initiate Multiple Follicular Growth in a Controlled Ovarian Hyperstimulation Protocol for IVF or IVF/ICSI (Study 38807) [Completed]

Study of Optimal Posology of Gonadotrophins in Patients With Insufficient Ovarian Response Due to Age [Recruiting]

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