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Synarel (Nafarelin Acetate Nasal) - Summary

 
 



SYNAREL SUMMARY

SYNAREL (nafarelin acetate) Nasal Solution is intended for administration as a spray to the nasal mucosa. Nafarelin acetate, the active component of SYNAREL Nasal Solution, is a decapeptide with the chemical name: 5-oxo- L -prolyl- L -histidyl- L -tryptophyl- L -seryl- L -tyrosyl-3-(2-naphthyl)- D -alanyl- L -leucyl- L -arginyl- L -prolyl-glycinamide acetate. Nafarelin acetate is a synthetic analog of the naturally occurring gonadotropin-releasing hormone (GnRH).

(For Central Precocious Puberty, See Reverse Side )

SYNAREL is indicated for management of endometriosis, including pain relief and reduction of endometriotic lesions. Experience with SYNAREL for the management of endometriosis has been limited to women 18 years of age and older treated for 6 months.


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NEWS HIGHLIGHTS

Published Studies Related to Synarel (Nafarelin Nasal)

A randomized, parallel, comparative study of the efficacy and safety of nafarelin versus danazol in the treatment of endometriosis in Taiwan. [2005.07]
BACKGROUND: The purpose of this study was to evaluate the efficacy and safety of nafarelin, a gonadotropin-releasing hormone (GnRH) analogue, versus danazol in the treatment of women with endometriosis in Taiwan... CONCLUSION: Nafarelin and danazol demonstrated similar clinical efficacy, but nafarelin was associated with fewer laboratory changes and a stable lipid profile, relative to danazol. Moreover, intranasally administered nafarelin is noninvasive, and may be a more comfortable and safer alternative to slow-release injectable GnRH agonists. Based on this study, we suggest that nafarelin, like other GnRH analogues, may be a treatment of choice for Taiwanese women with endometriosis. However, direct comparative studies of nafarelin with slow-release injectable GnRH agonists are now required.

Reversible downregulation of endocrine and germinative testicular function (hormonal castration) in the dog with the GnRH-agonist azagly-nafarelin as a removable implant "Gonazon"; a preclinical trial. [2009.04.15]
Downregulation of anterior pituitary GnRH-receptors by application of a slow release GnRH-implant offers an effective and reversible alternative to surgical castration of the male dog. Aim of the present study was to test the efficacy and the underlying mechanisms of a new non-biodegradable controlled-release device implant (Gonazon((R)), Intervet, containing 18.5mg of the GnRH-agonist Azagly-Nafarelin).

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Clinical Trials Related to Synarel (Nafarelin Nasal)

Endometriosis : Traditional Medicine vs Hormone Therapy [Completed]
This 36-week study will determine whether traditional Chinese medicine (acupuncture and Chinese herbs) is as effective as hormone therapy for alleviating endometriosis-related pelvic pain.

Short Versus Long Protocol for IVF and IVF+ICSI [Active, not recruiting]
Purpose: Comparing a GnRH agonist and an antagonist protocol for IVF/ICSI with regard to 1. frequency of ovarian hyperstimulation syndrome (OHSS) (1. outcome measure) 2. quality of life (2. outcome measure) 3. live birth rate (2. outcome measure) 4. gene expression profiles of granulosa and cumulus cells, and concentrations of estradiol and vascular endothelial growth factor in follicular fluid(not only compared between GnRH agonist and antagonist protocol, but also between patients with OHSS and no OHSS and patients becoming pregnant and not becoming pregnant (2. outcome measure), and 5. number of oocytes removed per treatment, number of embryo transfers per treatment and number of spontaneous abortions per treatment (these three parameters are tertiary outcome measures). In addition to the above mentioned efficacy outcome measures the safety outcome measure "frequency of known side-effects" will be compared between the two protocols.

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Reports of Suspected Synarel (Nafarelin Nasal) Side Effects

Respiratory Distress (3)Cerebral Infarction (3)Uterine Haemorrhage (3)Endometrial Hyperplasia (2)Vascular Dissection (2)Visual Impairment (2)Endometrial Atrophy (2)Drug Ineffective (1)Osteoporosis (1)Pain (1)more >>


Page last updated: 2009-10-20

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