Goserelin
GnRH altered at positions 6 and 10 and set into a 1-millimetre biodegradable rod that is pushed under the skin of the abdomen every 28 days or every 12 weeks. It stimulates the pituitary first, then shuts testosterone or oestrogen down.
Goserelin (Zoladex) switches the reproductive hormones off on purpose: for prostate cancer, advanced breast cancer before menopause, endometriosis and thinning the womb lining before surgery. Its label describes a brief flare, then castrate testosterone within 2 to 4 weeks or postmenopausal oestrogen within 3. Hot flashes, bone loss and reports of serious bleeding where the implant goes in are the costs.
What is it?
Goserelin is gonadotropin-releasing hormone with two substitutions: a D-serine carrying a tert-butyl group at position 6 and an aza-glycinamide at position 10, which the label writes as [D-Ser(But)6, Azgly10]. It keeps all ten positions, so unlike leuprolide it is still a decapeptide, with a free-base mass of 1,269 daltons. Like every GnRH agonist it works against its own name. Pulses of GnRH switch the reproductive axis on; a steady supply first stimulates the pituitary and then silences it. The label describes the sequence in men as a rise in luteinising hormone, follicle-stimulating hormone and testosterone, followed by testosterone in the range seen after surgical castration about 2 to 4 weeks after the start. In women, estradiol reaches postmenopausal levels within 3 weeks.
The delivery is what sets goserelin apart. Zoladex is not a liquid or a suspension of microspheres but a solid cylinder 1 millimetre across: goserelin dispersed in a copolymer of lactic and glycolic acids, preloaded in a syringe with a 16-gauge needle and placed under the skin of the front abdominal wall, below the navel. The 3.6 mg implant is given every 28 days and the 10.8 mg implant every 12 weeks. A 1991 review put the 3.6 mg depot's release at about 120 micrograms a day over four weeks; the label adds that release is slower for the first eight days and faster afterwards, with blood levels in men peaking at about 2.8 ng/mL between days 12 and 15. Free goserelin is gone within hours. Its elimination half-life after a solution dose is 4.2 hours in men and 2.3 hours in women, rising to 12.1 hours in severe kidney impairment, yet neither the label nor a 2000 pharmacokinetic review calls for a dose change, because the depot's release rate is what shapes the blood levels.
In the US the 3.6 mg implant was approved on December 29, 1989 (NDA 019726) and the 10.8 mg implant on January 11, 1996 (NDA 020578). First developed by ICI, the company a 2002 review names as AstraZeneca's predecessor, Zoladex is sold in the US today by TerSera Therapeutics, which Drugs@FDA lists as the holder of both applications. The 3.6 mg label covers five uses: with flutamide for stage T2b to T4 (B2 to C) prostate cancer, started eight weeks before radiotherapy; palliative treatment of advanced prostate cancer; endometriosis, for six months in women 18 and older; thinning the endometrium before ablation for dysfunctional uterine bleeding; and palliative treatment of advanced breast cancer in pre- and perimenopausal women. The 10.8 mg label covers only the two prostate uses and says the implant is not indicated in women, because the data are insufficient to support reliable suppression of serum estradiol.
Prostate cancer is where goserelin began. A 1991 review found partial remission or stabilisation in about 75% of men with untreated disease, a rate equivalent to orchidectomy or diethylstilbestrol, and the label reports survival similar to orchiectomy in a comparative trial. The flare is real: prostate markers rose in 8 of 65 men (12%) during the first weeks of a 1986 series, and in a 2001 study 82% of men starting leuprolide or goserelin had a testosterone surge in week 1, against none on the antagonist abarelix. The label's combined-therapy trial randomised 466 men with bulky disease confined to or just beyond the prostate: goserelin and flutamide before and during radiation lowered local failure at four years from 33% to 16% and lengthened median disease-free survival from 2.6 to 4.4 years. A review of five adjuvant trials in more than 3,500 men found better clinical disease-free survival with goserelin in every one. Against degarelix, an antagonist, prostate volume shrank by the same amount over 12 weeks (39.0% against 37.2%), though goserelin needed bicalutamide cover for its first 28 days and relieved urinary symptoms less in men who had moderate or severe ones. Newer formulations are measured against the implant: a monthly goserelin microsphere injection (LY01005) matched it in a Chinese phase III trial of 290 men, with castrate testosterone at day 29 in 99.3% against 100%.
In premenopausal women with metastatic breast cancer, goserelin was tested against surgery. The German Zoladex Trial Group gave it first-line to 134 women: estradiol fell into the postmenopausal range within 2 to 3 weeks, and 44.9% of the 118 who could be evaluated responded, 10.2% completely. A US intergroup trial randomised 136 women with receptor-positive disease to goserelin or ovariectomy and found similar failure-free and overall survival (death hazard ratio 0.80, 95% CI 0.53 to 1.20), with more hot flashes (75% against 46%) and more tumour flare (16% against 3%) on the drug; it closed early, with 60% power. The label reports interim data from SWOG-8692, a trial of the same comparison, in 124 women: best objective response 22% against 12%, median survival 33.2 against 33.6 months. An Italian 2 x 2 trial of 85 women reached the same verdict, comparable survival however the ovaries were switched off, with tamoxifen adding side effects.
In early breast cancer, goserelin's case was built as an alternative to chemotherapy. In the ZEBRA trial, 1,640 premenopausal women with node-positive disease received two years of goserelin or six cycles of CMF: in the roughly three quarters with oestrogen-receptor-positive tumours disease-free survival was equivalent (HR 1.01), but in receptor-negative tumours goserelin was worse (HR 1.76). The difference patients notice is reversibility. Over 95% stopped menstruating within six months of starting goserelin, but at three years 22.6% were still amenorrhoeic against 76.9% after CMF. The ZIPP analysis of 2,710 women found that adding two years of goserelin to standard care improved event-free survival (HR 0.80) and overall survival (HR 0.81). Its Stockholm arm, followed for 20 years, found that goserelin, tamoxifen and the two together all lengthened the distant recurrence-free interval in receptor-positive disease (HR 0.49, 0.57 and 0.63), but the combination was never better than either drug alone, and in genomically high-risk tumours adding tamoxifen to goserelin raised the risk (HR 3.36). None of this is on the US label, which covers advanced breast cancer only. A 2025 study of US health records nonetheless found women with early-stage disease among those starting goserelin, and found the 10.8 mg depot non-inferior to monthly 3.6 mg at 12 months (79.2% against 76.6% event-free), although the US 10.8 mg label excludes women.
For endometriosis the label limits treatment to six months and does not recommend retreatment, because safety data for it are not available. In two danazol-controlled trials, lesions shrank by half or more in 63% and 62% of women on goserelin against 42% and 51% on danazol, and 92% and 80% stopped menstruating within eight weeks. An open study of 146 women in Germany and Austria saw symptom scores fall by 86% and 93%, visible deposits cleared completely in 31.5% at a second laparoscopy, and 20 of 64 previously infertile women conceive within a year. The cost is bone: 109 women lost an average of 4.3% of spinal bone density in six months, recovering only partly (2.5% below baseline a year after treatment in the 28 measured), and adding back hormone replacement reduced both the loss and the hot flushes without weakening pain relief. Before endometrial ablation, two depots in a placebo-controlled trial of 358 women thinned the lining to a median 1.50 mm against 3.55 mm and raised amenorrhoea six months after surgery from 26% to 40%. Beyond the label, a 47-woman trial found six months of goserelin better than medroxyprogesterone for pelvic congestion, and a 2026 review lists fibroids and ovarian downregulation before assisted reproduction among goserelin's approved gynaecological uses; neither appears on the US label.
The label's warnings are those of hormone suppression plus a few of the implant's own. Pregnancy must be excluded before treatment for a benign condition, and non-hormonal contraception is required during treatment and for 12 weeks after; goserelin can cause fetal harm and is contraindicated in pregnancy except in advanced breast cancer. Men face hyperglycaemia and diabetes, reported increases in heart attack, sudden cardiac death and stroke, and QT prolongation; women may develop or worsen depression. Specific to the implant, injection-site and vascular injury, including haemorrhage and haemorrhagic shock requiring transfusion and surgery, has been reported, and the label asks for extra care in people with a low body-mass index or on full-dose anticoagulation. The label's September 2025 changes added severe cutaneous reactions, among them Stevens-Johnson syndrome, DRESS and AGEP, and post-marketing reports include pituitary apoplexy, mostly within two weeks of the first dose. Goserelin is a cancer and gynaecology drug placed by clinicians. In sport, WADA's Prohibited List names it among the releasing factors prohibited for males, and GnRH analogues are monitored in girls under 18.
Mechanism of Action
Goserelin binds the pituitary GnRH receptor as the natural hormone does, but an implant that never stops releasing it turns the receptor's message from 'release LH and FSH' into silence. Its uses and its side effects both follow from that switch.
First, a flare
Testosterone or estradiol rises at the start. Prostate markers rose in 12% of men in one series and tumour flare affected 16% of women in a breast cancer trial, which is why the label warns of ureteral obstruction and spinal cord compression.
Then shutdown
Testosterone reaches the surgical-castration range about 2 to 4 weeks in, estradiol reaches postmenopausal levels within 3 weeks, and LH and FSH settle at follicular-phase levels within four weeks (label).
The implant sets the clock
Free goserelin's half-life after a solution dose is 4.2 hours in men and 2.3 in women, so the drug is used only as a depot: a lactide-glycolide rod releasing it over 28 days (3.6 mg) or 12 weeks (10.8 mg).
Reversible
Estradiol, LH and FSH return to pretreatment values within 12 weeks of the last implant in all but rare cases (label), and in the ZEBRA trial most women's periods came back after two years of treatment.
Published Research
PubMed returns about 2,200 records for goserelin. Our evidence set holds 51 papers; 37 name it or Zoladex in their titles, 30 of those have an abstract, and 22 are carded below: 15 studies in people, 6 reviews and 1 animal study. Goserelin has been prescribed since the late 1980s, so its evidence runs from registration-era trials to 20-year follow-up and real-world records.
The early review: prostate, breast, gynaecology
The 3.6 mg depot releases about 120 micrograms a day over 4 weeks. In previously untreated prostate cancer it produced partial remission or stabilisation in about 75% of men, equivalent to orchidectomy or diethylstilbestrol and better tolerated than the latter; 30 to 45% of premenopausal women with breast cancer responded. The early testosterone rise can cause a flare, and hot flushes and loss of libido affect most patients.
Clinical pharmacokinetics
Given as a solution, goserelin is absorbed and cleared quickly: elimination half-life 4.2 hours in men and 2.3 hours in women, rising to 12.1 hours in severe renal impairment. The lactide-glycolide depot sets the blood profile over 1 or 3 months, with no clinically relevant accumulation and no dose change needed for age or kidney or liver impairment.
The three-month 10.8 mg depot
In phase III trials, one 10.8 mg depot gave almost the same testosterone suppression as three consecutive 3.6 mg depots, with adverse reactions in 52.6% (41 of 78) against 54.8% (46 of 84). In a Japanese phase II study all 20 untreated men reached castration, and PSA normalised in 75% of them.
PSA during treatment, 65 men with prostate cancer
PSA and prostatic acid phosphatase rose in 8 of 65 men (12%) during the induction phase. Baseline markers did not predict response, but levels after treatment did: median PSA at 6 months was 2.5 ng/mL in responders against 51.5 ng/mL in non-responders, making PSA the most sensitive marker of response.
The agonist surge against an antagonist, 242 men
In this phase 2 study, 82% of 33 men starting leuprolide or goserelin had a testosterone surge in week 1 and none was castrate by the end of it; on the antagonist abarelix (209 men) there was no surge and 75% were castrate within the first week. Giving an antiandrogen alongside made no difference.
Goserelin plus bicalutamide against degarelix, 182 men
Over 12 weeks prostate volume shrank by similar amounts (39.0% with goserelin, 37.2% with degarelix; non-inferior). The goserelin group took bicalutamide for its first 28 days as flare protection. In men with moderate or severe urinary symptoms (IPSS above 13), degarelix improved scores more (-6.7 against -4.0 points).
Adjuvant goserelin in localised prostate cancer, 5 trials
Across five randomised trials of more than 3,500 men (four with radiotherapy, one with radical prostatectomy; median follow-up 4.8 to 7.1 years), goserelin support improved clinical disease-free survival in all five. Disease-related mortality fell significantly in one radiotherapy trial and in the prostatectomy trial.
A monthly microsphere against the implant, 290 men
In a phase III non-inferiority trial at 49 sites in China, testosterone was below the castration level at day 29 in 99.3% on LY01005 (goserelin microspheres) and 100% on the Zoladex implant, and stayed there from day 29 to 85 in 99.3% and 97.8%. Injection-site reactions: 0% against 1.4% (2 of 145) with the implant.
Metastatic breast cancer before menopause, 134 women
As first-line therapy, goserelin brought estradiol into the castrate or postmenopausal range within 2 to 3 weeks and held it there. Of 118 evaluable women, 10.2% had a complete and 34.7% a partial remission; responses were commoner with receptor-positive (49.3%) than receptor-poor tumours (33.3%), and the depot was well tolerated.
How long responses last, 75 premenopausal women
An objective response occurred in 33% and lasted a median of more than 15 months; 9% responded completely. Response tracked the tumour's oestrogen receptor status. The authors note that 53% progressed on goserelin and so were spared an irreversible oophorectomy.
Surgery or goserelin, with or without tamoxifen, 85 women
In a 2 x 2 randomised trial, responses were 27.2% with goserelin, 45% with goserelin plus tamoxifen, 46.6% with oophorectomy (or ovarian irradiation) and 11.1% with oophorectomy plus tamoxifen. Survival was comparable across arms; the authors judged medical and surgical castration similarly effective, with tamoxifen adding side effects.
Goserelin against ovariectomy, 136 women
In receptor-positive metastatic breast cancer, failure-free and overall survival were similar (death hazard ratio 0.80, 95% CI 0.53 to 1.20). Goserelin lowered estradiol to postmenopausal levels but caused more hot flashes (75% against 46%) and tumour flare (16% against 3%). Slow accrual ended the trial early, at 60% power.
ZEBRA: two years of goserelin against CMF, 1,640 women
In node-positive early breast cancer, goserelin equalled CMF chemotherapy for disease-free survival in receptor-positive tumours (HR 1.01) but was inferior in receptor-negative ones (HR 1.76). Over 95% stopped menstruating within 6 months, against 58.6% on CMF; at 3 years 22.6% against 76.9% were still amenorrhoeic, because periods returned after goserelin.
ZIPP: goserelin added to standard care, 2,710 women
A combined analysis of four randomised trials: adding 2 years of goserelin to radiotherapy and/or chemotherapy, with or without tamoxifen, improved event-free survival (HR 0.80, 95% CI 0.69 to 0.92) and overall survival (HR 0.81, 0.67 to 0.99) at a median 5.5 years, and goserelin was well tolerated.
The Stockholm arm of ZIPP, 927 women
At a median 12.3 years, goserelin alone cut the risk of a first event by 32% and tamoxifen alone by 27%; the two together cut it by 24%, no better than either. The largest goserelin effect was without tamoxifen (HR 0.52) and in strongly receptor-positive tumours. The authors caution that it was not a preplanned subset analysis.
The same trial at 20 years, 924 women
In the 584 receptor-positive patients, 2 years of goserelin (HR 0.49), tamoxifen (0.57) or both (0.63) lengthened the distant recurrence-free interval compared with no endocrine therapy. The combination beat neither drug alone; genomically high-risk tumours gained from goserelin (HR 0.24), and adding tamoxifen to goserelin raised their risk (HR 3.36).
Three-monthly against monthly, US records, 698 women
In US electronic records of premenopausal women with breast cancer, 12-month real-world event-free survival was 79.2% on the 10.8 mg depot (123 women) and 76.6% on 3.6 mg monthly (575), within a -15% non-inferiority margin, both for early-stage or locally advanced disease and for metastatic disease.
Six months for endometriosis, 146 women
In an open study, one 3.6 mg depot every 4 weeks for 6 months cut subjective and pelvic symptom scores by 86% and 93%, and they stayed below a fifth of baseline through 48 weeks. At second laparoscopy 54% had implants and adhesions reduced by half or more and 31.5% had none visible; 20 of 64 previously infertile women conceived within a year. Most had hot flushes and vaginal dryness.
With or without add-back hormones, endometriosis
In a trial at 42 hospitals, adding hormone replacement to goserelin relieved pelvic symptoms as well as goserelin alone while reducing bone density loss, hot flushes and vaginal dryness. Some bone loss occurred in every group, most without add-back.
Pelvic congestion, 47 women
Six months of goserelin 3.6 mg monthly beat medroxyprogesterone 30 mg daily: one year after treatment it gave more improvement on pelvic venography, and better symptom relief, sexual function and anxiety and depression scores (P = 0.0001).
Gynaecological uses, a 2026 review
Lists endometriosis, uterine fibroids, endometrial thinning and ovarian downregulation before assisted reproduction among goserelin's approved gynaecological indications, all resting on sustained receptor desensitisation, with adenomyosis and gynaecological cancers under study.
A dissolving microneedle patch
A patch of fast-dissolving microneedles carrying goserelin microspheres penetrated the skin and sustained release over 28 days in animal testing, with therapeutic results comparable to intramuscular goserelin microspheres, pointing to a less invasive alternative to the implant.
Dosing Data
Goserelin is dosed by label and placed by a clinician. The two implants are not interchangeable for women: only the 3.6 mg implant is labelled for them.
Educational information, not medical advice. Each dose above is tagged with its source: an approved label, a published human study, animal data, or amounts reported by users. None is a recommendation for you. An unapproved compound has no established safe or effective human dose, and products sold for “research use only” are not made or tested for people. Talk to a doctor before acting on anything on this site, including before you start, stop or change any medicine or dose. Full medical disclaimer.
Side Effects & Contraindications
Reported Side Effects
From the labels and the studies above.
Contraindications & Cautions
From the labels; a clinician decides.
Legal Status
Goserelin is an approved prescription medicine. The sport row below comes from the dataset.
Frequently Asked Questions
?What is goserelin used for?
The US 3.6 mg label lists five uses: localised stage B2 to C prostate cancer with flutamide and radiotherapy, palliative treatment of advanced prostate cancer, endometriosis, endometrial thinning before ablation, and palliative treatment of advanced breast cancer before or around menopause. The 10.8 mg implant is labelled only for the two prostate uses.
?Why can goserelin make symptoms worse at first?
Because it stimulates the GnRH receptor before it exhausts it. Testosterone or estradiol rises briefly, and the label warns of transient worsening of cancer symptoms, including isolated cases of ureteral obstruction and spinal cord compression. In a breast cancer trial, 16% of women on goserelin had a tumour flare against 3% after ovariectomy.
?How is the implant given, and can it cause problems?
A clinician places a 1-millimetre rod under the skin of the front abdominal wall, below the navel, from a preloaded syringe with a 16-gauge needle. The label warns that injection-site and vascular injury, including haemorrhage and haemorrhagic shock requiring transfusion and surgery, has been reported, and asks for extra care in people with a low body-mass index or on full-dose anticoagulation.
?Is goserelin as effective as removing the ovaries?
In premenopausal women with metastatic breast cancer, randomised trials found similar survival: a US intergroup trial of 136 women gave a death hazard ratio of 0.80 (95% CI 0.53 to 1.20), and an Italian trial of 85 women found comparable survival. The drug is reversible, but hot flashes (75% against 46%) and tumour flare were more common with it.
?Does goserelin cause bone loss?
Yes. In 109 women treated for six months, spinal bone density fell 4.3% on average and was still 2.5% below baseline a year later in the 28 who were measured. Adding back hormone replacement reduced the loss without weakening symptom relief, and the endometriosis label stops at six months.
?Is goserelin banned in sport?
For men, yes: WADA's Prohibited List names goserelin under S2.2.1, and the Legal table below gives the 2026 and 2027 entries. GnRH analogues are also on WADA's Monitoring Program for female athletes under 18.
References
- [fda-pi] Zoladex (goserelin implant) 3.6 mg and 10.8 mg Prescribing Information. TerSera Therapeutics LLC (DailyMed versions published 2026-03-26, read 2026-09-28).
- [fda-pi] US FDA, Drugs@FDA: Zoladex implant NDA 019726 (3.6 mg, approved 1989-12-29) and NDA 020578 (10.8 mg, approved 1996-01-11), both held by TerSera Therapeutics (read 2026-09-28).
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- [pubmed] Boccardo F, et al. "Ovarian ablation versus goserelin with or without tamoxifen in pre-perimenopausal patients with advanced breast cancer: results of a multicentric Italian study." Ann Oncol, 1994;5(4):337-42. PMID: 8075030.
- [pubmed] Taylor CW, et al. "Multicenter randomized clinical trial of goserelin versus surgical ovariectomy in premenopausal patients with receptor-positive metastatic breast cancer: an intergroup study." J Clin Oncol, 1998;16(3):994-9. PMID: 9508182.
- [pubmed] Jonat W, et al. "Goserelin versus cyclophosphamide, methotrexate, and fluorouracil as adjuvant therapy in premenopausal patients with node-positive breast cancer: The Zoladex Early Breast Cancer Research Association Study." J Clin Oncol, 2002;20(24):4628-35. PMID: 12488406.
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Sources & Citations
Every PubMed citation on this page has been checked against its record. The Zoladex 3.6 mg and 10.8 mg labels (DailyMed, published March 26, 2026) and Drugs@FDA were read on September 28, 2026. Grey Peptides sells nothing and links to no vendor.
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