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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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. [2009.04]
OBJECTIVE: To assess the efficacy and safety of a vaginal progesterone (P(4)) insert (Endometrin) for luteal support for assisted reproductive technology (ART).Endometrin was safe and well tolerated.
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]
OBJECTIVE: To assess the efficacy and safety of a vaginal progesterone (P(4)) insert (Endometrin) for luteal support for assisted reproductive technology (ART).Endometrin was safe and well tolerated.
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]
OBJECTIVE: To compare the efficacy and safety of three different ratios of human-derived follicle-stimulating hormone/human menopausal gonadotropin (human-derived FSH:hMG, Bravelle and Repronex) mixed together in the same syringe and administered subcutaneously once daily, to in vitro fertilization (IVF) patients <34 years or 34 to 40 years of age...
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]
BACKGROUND: These data compare the efficacy and safety of highly purified human-derived follicle-stimulating hormone (Bravelle) and recombinant follitropin-beta (Follistim) in women undergoing in vitro fertilization... CONCLUSIONS: Bravelle and Follistim had comparable efficacy in controlled ovarian hyperstimulation in women undergoing IVF-ET. There were no differences in the nature or number of adverse events between the treatment groups although Bravelle injections were reported to be significantly less painful.
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]
OBJECTIVE: To compare the efficacy and safety of Bravelle s.c., Bravelle i.m., and Follistim s.c...
Clinical Trials Related to Bravelle (Urofollitropin)
CONSORT Randomised Controlled Trial in Assisted Reproductive Technology [Recruiting]
Investigation of a Long Acting Follicle Stimulating Hormone in Women Undergoing Assisted Reproductive Technology (ART) [Active, not recruiting]
Study to evaluate a new investigational long-acting follicle stimulating hormone in infertile
women who are undergoing an assisted reproductive technology procedure (IVF/ICSI). This study
will compare three doses of the investigational drug vs a currently marketed medication
(Gonal-f® RFF Pen) in regards to the number of fertilized eggs.
AS900672-Enriched in Ovulation Induction [Recruiting]
Study to evaluate a new investigational long-acting follicle stimulating hormone in
oligo-anovulatory women undergoing ovulation induction. This study will compare 4 doses of
the investigational drug vs a currently marketed medication (GONAL-f) prefilled pen with
regards to ovulation rate.
MENOPUR® Versus FOLLISTIM® [Recruiting]
To compare the efficacy and safety of MENOPUR® with that of FOLLISTIM® in patients who are
undergoing GnRH antagonist IVF cycles
Menopur® Versus Follistim® in Polycystic Ovarian Syndrome (PCOS) [Recruiting]
This multicenter, randomized, open-label exploratory study will be performed in
approximately 200 PCOS but otherwise healthy females undergoing IVF. Each study center will
follow its standard practice for IVF within the study parameters as noted in this protocol.
The study centers will use marketed products purchased from Schraft's Pharmacy for all
phases of the study (down-regulation, stimulation, ovulation induction, and luteal support).
Subjects will be randomly assigned to Menopur® or Follistim Pen® for stimulation and
Endometrin® or progesterone in oil for luteal support. Subjects will return to the study
center for regular scheduled clinic visits as required per IVF protocol at the site and at
specified times during the cycle (Stimulation Day 6, Day of hCG, and first serum pregnancy
test) for estradiol (E2), progesterone (P4) and hCG labs. All subjects will be required to
complete a final study visit at completion of luteal support or negative serum pregnancy
test following embryo transfer.
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