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Zoladex (Goserelin Acetate) - Summary



(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.

See all Zoladex indications & dosage >>


Published Studies Related to Zoladex (Goserelin)

Neoadjuvant anastrozole versus tamoxifen in patients receiving goserelin for premenopausal breast cancer (STAGE): a double-blind, randomised phase 3 trial. [2012]
goserelin for early breast cancer in the neoadjuvant setting... INTERPRETATION: Given its favourable risk-benefit profile, the combination of

Monthly versus 3-monthly goserelin acetate treatment in pre-menopausal patients with estrogen receptor-positive early breast cancer. [2011.04]
This study compared the efficacy and safety of a 3-monthly 10.8-mg depot goserelin (Zoladex(TM)) injection with the current 3.6 mg monthly dose in pre-menopausal Japanese women with estrogen receptor-positive (ER+) early breast cancer. This was a multicenter, open-label, randomized study.In terms of E(2) suppression, 3-monthly goserelin 10.8 mg was non-inferior to monthly goserelin 3.6 mg in pre-menopausal women with ER+ breast cancer.

Randomized comparison of goserelin versus suction curettage prior to Thermachoice II balloon endometrial ablation: one-year results. [2010.10]
OBJECTIVES: To evaluate the clinical outcomes following the use of goserelin and suction curettage prior to ThermaChoice II balloon endometrial ablation to treat menorrhagia... CONCLUSION: At one year after ThermaChoice II treatment, 88.5% of women had normal menstrual bleeding or less. There was a non-significant trend (a lower Higham score) towards superiority of goserelin therapy before ablation compared with curettage.

Long-term effectiveness of adjuvant goserelin in premenopausal women with early breast cancer. [2009.03.04]
BACKGROUND: Systematic reviews have found that luteinizing hormone-releasing hormone (LHRH) agonists are effective in treating premenopausal women with early breast cancer... CONCLUSIONS: Two years of goserelin treatment was as effective as 2 years of tamoxifen treatment 15 years after starting therapy. In women who did not take tamoxifen, there was a large benefit of goserelin treatment on survival and recurrence, and in women who did take tamoxifen, there was a marginal potential benefit on these outcomes when goserelin was added.

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]
OBJECTIVE: To compare the mechanism of action of raloxifene and gosereline induced shrinkage of leiomyomas via estrogen receptor, progesterone receptor, bcl-2 and p53 expression immunohistochemically... CONCLUSION: Raloxifene was as effective as gosereline in reducing leiomyoma volumes. Decreased PR expression may be a mechanism for tumor growth reduction in raloxifene treatment. In both treatment modalities, the mechanism of shrinkage of leiomyomas could not be increased apoptosis mediated by bcl-2 and p53 expression and should be investigated by further studies.

more studies >>

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]
The primary purpose of this study is to establish if a 10. 8 mg dose of ZOLADEX given 3 monthly is non-inferior to a 3. 6 mg dose of ZOLADEX given monthly in terms of oestradiol suppression in patients with oestrogen receptor positive early breast cancer.

Study of Zoladex Given Every 12 Weeks Versus Given Every Month in Advanced Breast Cancer (ABC) Pre-Menopausal Women [Suspended]
The primary objective is to evaluate whether Zoladex 10. 8 mg (12-weekly) is non-inferior to Zoladex 3. 6 mg (4-weekly) in pre-menopausal women with oestrogen receptor positive advanced breast cancer by assessment of progression-free survival at 24 weeks.

A temporary halt to patient recruitment was placed on the study on December 24th 2007, pending confirmation/approval from the Japanese PMDA. The meeting with the PMDA will now take place in July/August 2008. The study has been halted with a total of 97 patients randomized and it is anticipated that the study stats and CSR for the primary objective (Data at 6-months) will be based on this patient number. These patients will then be followed to the secondary endpoint at 2 years, when the final stats and CSR will be produced.

Study to Compare Zoladex™ 10.8 mg With Zoladex 3.6 mg in Pre-menopausal Women With Breast Cancer [Recruiting]
The purpose of this study is to examine the efficacy and safety as well as the characteristics of the female hormone and study medications after administration in pre-menopausal women with advanced or recurrent breast cancer who were randomised in a 1: 1 ratio to either of the two treatment groups; the ZD9393 3. 6 mg depot group or ZD9393 10. 8 mg depot group, both given in combination with tamoxifen tablets.

Goserelin and Letrozole or Anastrozole in Premenopausal Patients With Stage II-III Estrogen Receptor-Positive Breast Cancer [Recruiting]
This phase II trial studies the impact of a presurgical endocrine therapy, consisting of goserelin with letrozole or anastrozole on the treatment of premenopausal patients with stage II-III estrogen receptor-positive (ER+) and human epidermal growth factor receptor 2 (HER2)-negative breast cancer. Endocrine therapy reduces the amount of estrogen in the body. E+ breast cancer require estrogen, so lower levels of estrogen may slow or stop cell growth. Giving goserelin together with letrozole or anastrozole before surgery may enhance the effectiveness of, or eliminate the need for, chemotherapy

PROstaTE Cancer Treatment and Obesity in Zoladex-Astrazeneca Treated Patients [Recruiting]
The reports on relationship of obesity and biochemical or clinical recurrence of prostate cancer are controversial. Several reports have shown that obesity is associated with increased risk of biochemical or clinical failure after radical prostatectomy. Other prospective studies have shown no adverse effect of obesity on long-term outcomes after prostatectomy. Limited reports are available on the impact of obesity on prostate cancer progression after radiotherapy. Primary: to assess percentage recurrence rate among normal weight and overweight or obese prostate cancer patients treated by adjuvant Zoladex therapy. Secondary: to determine the Quality of Life differences among normal and overweight or obese prostate cancer patients by a Quality of Life questionnaire

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Reports of Suspected Zoladex (Goserelin) Side Effects

Death (60)Prostate Cancer (17)Hot Flush (14)Pain (8)Headache (8)Prostatic Specific Antigen Increased (8)Hepatic Function Abnormal (7)Wrong Technique in Drug Usage Process (7)Disease Progression (7)Prostate Cancer Metastatic (7)more >>

Page last updated: 2013-02-10

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