Zoladex (Goserelin Acetate) - Summary

ZOLADEX SUMMARY

ZOLADEX®
(goserelin acetate implant)
3.6 MG

ZOLADEX® (goserelin acetate implant), contains a potent synthetic decapeptide analogue of luteinizing hormone-releasing hormone (LHRH), also known as a gonado-tropin releasing hormone (GnRH) agonist analogue.

ZOLADEX® is indicated for the following:

Prostatic Carcinoma: ZOLADEX is indicated in the palliative treatment of advanced carcinoma of the prostate.

Stage B2-C Prostatic Carcinoma: ZOLADEX is indicated for use in combination with flutamide for the management of locally confined Stage T2b-T4 (Stage B2-C) carcinoma of the prostate. Treatment with ZOLADEX and flutamide should start 8 weeks prior to initiating radiation therapy and continue during radiation therapy.

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

Advanced Breast Cancer: ZOLADEX is indicated for use in the palliative treatment of advanced breast cancer in pre- and perimenopausal women.

The estrogen and progesterone receptor values may help to predict whether ZOLADEX therapy is likely to be beneficial. (See CLINICAL PHARMACOLOGY.)

Endometrial Thinning: ZOLADEX is indicated for use as an endometrial-thinning agent prior to endometrial ablation for dysfunctional uterine bleeding.

The automatic safety feature of the syringe aids in the prevention of needlestick injury.

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ZOLADEX NEWS HIGHLIGHTS

Published Studies Related to Zoladex (Goserelin)

A comparative study of the effect of raloxifene and gosereline on uterine leiomyoma volume changes and estrogen receptor, progesterone receptor, bcl-2 and p53 expression immunohistochemically in premenopausal women. [2007.11]

Goserelin Acetate 10.8 mg Plus Iron Versus Iron Monotherapy Prior to Surgery in Premenopausal Women with Iron-Deficiency Anemia Due to Uterine Leiomyomas: Results from a Phase III, Randomized, Multicenter, Double-Blind, Controlled Trial. [2007.08]

Adjuvant chemotherapy followed by goserelin compared with either modality alone: the impact on amenorrhea, hot flashes, and quality of life in premenopausal patients--the International Breast Cancer Study Group Trial VIII. [2007.01.20]

Treatment of dysfunctional uterine bleeding in the perimenopause: the effects of adding combined estradiol/norethisterone acetate therapy to goserelin acetate treatment--a randomized, placebo-controlled, double-blind trial. [2006.12]

CMF versus goserelin as adjuvant therapy for node-negative, hormone-receptor-positive breast cancer in premenopausal patients: a randomised trial (GABG trial IV-A-93). [2006.08]

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Clinical Trials Related to Zoladex (Goserelin)

Comparative Study of Oestradiol Suppression: Zoladex 10.8mg/3 Month vs. 3.6mg/Month in ER +ve EBC Pre-Menopausal Patients [Active, not recruiting]

Study of Zoladex Given Every 12 Weeks Versus Given Every Month in Advanced Breast Cancer (ABC) Pre-Menopausal Women [Suspended]

Estradiol Suppression for the Treatment of Metastatic Breast Cancer in Premenopausal Women [Active, not recruiting]

A Prospective, Single-Arm Study to Evaluate the Efficacy and Safety of Zoladex 3.6mg Combined With CEF Chemotherapy as Neo-Adjuvant Therapy in Hormone Responsive, Premenopausal, Operable Breast Cancer [Recruiting]

Casodex/Zoladex Biomarkers in Localised Prostate Cancer [Completed]

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