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Zoladex™ (goserelin acetate) Clinical Trial report summaries

Zoladex™ (goserelin acetate) is an injectable luteinising hormone-releasing hormone analogue (LHRHa). It stops the production of sex hormones (testosterone and oestrogen) and is used to treat hormone-sensitive cancers of the prostate and breast (in pre-/perimenopausal women) and some benign gynaecological disorders (endometriosis, uterine fibroids and endometrial thinning). In addition, Zoladex is used in assisted reproduction  

Please consult the prescribing information for the country concerned for guidance on the approved use of Zoladex™ (goserelin acetate).

Study Number Completed Clinical Trial Report Summaries

9393IL0025

A Multicenter Controlled Trial of Goserelin Acetate (ZOLADEXÔ) 3-Month 10.8-mg Depot Plus Iron Versus Sham Plus Iron for the Preoperative Management of Premenopausal Women with Iron Deficiency Anemia due to Uterine Fibroids

9393IL/0027

An Open-label, Multicentre, Parallel Group Trial to Investigate the Return of Ovarian Function Following the Administration of Two ZOLADEX 10.8 mg Depots or Six ZOLADEX 3.6 mg Depots in Women With Endometriosis - Follow on Study from Trial 9393IL/0026

9393IL/0028

A Randomized Clinical Trial Comparing Goserelin Acetate (ZOLADEXÔ) 3.6-mg Depot and Goserelin Acetate (ZOLADEX) 10.8-mg Depot in Subjects with Prostate Cancer for Whom Hormonal Therapy Is Indicated

ACO5

An Open, Randomised Trial Comparing Combination Chemotherapy (CMF) Versus ZOLADEX + Tamoxifen (NOLVADEXÔ) in Premenopausal, Hormone Receptor-Positive, Lymph Node-positive or Lymph Node-negative Patients With Operable Breast Cancer

INT0101

An Open, Randomized Trial Comparing Combination Chemotherapy (CAF) and Chemohormonal Therapy (CAF + ZOLADEX or CAF + ZOLADEX + Tamoxifen) in Premenopausal Women with Axillary Node-positive, Receptor-positive Breast Cancer

RTOG86-10

PHASE III RADIATION THERAPY ONCOLOGY GROUP (RTOG) TRIAL 86-10 OF ANDROGEN DEPRIVATION ADJUVANT TO DEFINITIVE RADIOTHERAPY IN LOCALLY ADVANCED CARCINOMA OF THE PROSTATE

ZXBC-1001

A Study by Japanese Association for Treatment of Breast Cancer with Zoladex (A study involving premenopausal subjects with advanced/recurrent breast cancer)

ZXBC-1002

An open, randomised, parallel-group phase III study to compare ZOLADEX 3.6 mg monotherapy with ZOLADEX 3.6 mg + tamoxifen or tamoxifen monotherapy in premenopausal Japanese women with oestrogen-positive breast cancer who had undergone curative resection

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