DOCSLIB.ORG

Randomised Crossover Trial to Assess the Tolerability of LHRH Analogue Administration

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Randomised Crossover Trial to Assess the Tolerability of LHRH Analogue Administration Prostate Cancer and Prostatic Diseases (2003) 6, 187–189 & 2003 Nature Publishing Group All rights reserved 1365-7852/03 $25.00 www.nature.com/pcan Randomised crossover trial to assess the tolerability of LHRH analogue administration G Williams1, S Lindsay1 & WG Bowsher1* 1Department of Urology, Royal Gwent Hospital, Newport, UK Luteinising hormone releasing hormone (LHRH) analogues are routinely used in the treatment of patients with advanced prostate cancer. This randomised crossover trial was conducted to compare patient comfort and tolerability between two commonly used LHRH analogues: goserelin acetate and leuprorelin acetate. A total of 50 patients were randomised into two groups, each receiving 6-monthly injections of leuprorelin acetate (a liquid presentation) and goserelin acetate (a depot pellet) and crossing over between treatments. Patients completed a simple visual analogue score for the discomfort felt from the injections. An analysis of variance model was used, and the results found that patients do tolerate leuprorelin acetate (0.589) better than goserelin acetate (1.343) (Po0.001, CI ¼ 95%). Prostate Cancer and Prostatic Diseases (2003) 6, 187–189. doi:10.1038/sj.pcan.4500625 Keywords: LHRH analogues; tolerability; patient discomfort Introduction While the efficacy of the preparations is similar, it is the administration of the medication that differs. Prostate cancer is the most common male cancer in Goserelin acetate is given subcutaneously as a depot Western countries and the second most common cause of pellet in the abdomen via a 16 Ch needle, often with the cancer death. The past 20 years have seen a 50% increase need for a local anaesthetic. Leuprorelin acetate, how- in the number of new cases diagnosed each year. With ever, is given as a liquid subcutaneously or intramuscu- the age of the population continuing to rise, it looks larly through a smaller needle (23 Ch or 21 Ch). While certain that the incidence of prostate cancer will both are well-established treatments, patient acceptabil- increase.1 ity of these different forms of administration has not For patients with advanced prostate cancer, luteinising been assessed. This study was undertaken to investigate hormone releasing hormone (LHRH) analogues such as whether there is a difference in patient tolerability leuprorelin acetate or goserelin acetate are most often between the two methods of administration. used. LHRH analogues are recommended by the British Association of Urological Surgeons (BAUS) as an alter- native to orchidectomy in the first-line treatment of metastatic prostate cancer.2 The analogues work by Methods suppressing the action of serum testosterone, and have been shown to produce a temporary remission of tumour Patients who were undergoing LHRH analogue therapy, growth in about 85% of patients. Treatment is given by a for prostate cancer, were recruited from the urology monthly or 3-monthly injection into the skin or abdomen. clinic at The Royal Gwent Hospital, Newport. The Often the treatment is combined with another type of patients were randomised into two groups, both receiv- anti-androgen therapy. Occasionally, other drugs will be ing a run-in period of 8 weeks goserelin acetate. This was used in the treatment, and severe pain in the bones often to allow the patients to normalise to the injection without responds dramatically to treatment with radiotherapy. a local anaesthetic. Four subsequent injections were given to all patients. Group A received two leuprorelin acetate injections followed by two goserelin acetate injections and Group B received two goserelin acetate injections followed by two leuprorelin acetate injections. *Correspondence: Mr WG Bowsher, Department of Urology, Royal Gwent Hospital, Newport NP20 2UB, UK. All the injections were administered monthly/4-weekly E-mail: [email protected] and without a local anaesthetic. The same nurse gave the Received 30 May 2002; revised 12 July 2002; accepted 24 July 2002 injections. Tolerability of LHRH analogue administration G Williams et al 188 At each visit, the patients recorded their experiences on a questionnaire including a simple Visual Analogue Symptom Scale (ranging from 0 ¼ no discomfort to 10 ¼ worst discomfort) to assess the level of discomfort experienced. Their discomfort was recorded both im- mediately after the injection and also 2 h later. An analysis of variance model was used to evaluate any treatment effects, with the between-patient factors of sequence LG (Group A) and GL (Group B) and patient and the within-patient factors of periods 1 and 2 and treatment being fitted. Due to the discrete nature of the data, a supportive nonparametric Wilcoxon matched- pairs rank sum test was also performed. Results A total of 50 patients were entered into the study, with 25 patients being randomised into each group. Of the patients, four were staged as having T2 disease, 26 as Figure 1 Discomfort scores for periods 1 and 2 experienced immediately T3, and 20 as T4. The mean age of the patients after the injection and also 2 h later. (Group A ¼ goserelin acetate (G) participating in the trial was 73 years (range 48–89). followed by leuprorelin acetate (L), Group B ¼ leuprorelin acetate (L) The length of time diagnosed with prostate cancer varied followed by goserelin acetate (G)). from 0 to 134 months (mean 20). The PSA levels on entering the study varied from 0.2 to 850 mg/l (mean in the run-in period. For the purposes of the summary 81.8 mg/l). While 40% (20) of the patients had received and analysis, the means of doses 3–4 (period 1) and 5–6 previous treatment for prostate cancer, only 26% (13) had (period 2) were used for each period. The results of these previously received LHRH analogues. scores are summarised in Figure 1. Of the 50 patients randomised, 42 (84%) completed the Of the 25 patients randomised to Group A, 24 patients 6-month study period and were included in the analysis. provided data for period 1 and 20 patients for period 2. Of the eight patients who withdrew, five were from Similarly, of the 25 randomised to Group B, 21 patients Group B and three were from Group A. The reasons for provided data for period 1 and 21 patients for period 2. withdrawal were: wished GP to give injection rather than Table 2 shows a summary of the results of the analysis continue at hospital (3); reluctance to have goserelin of variance. A difference (95% CI) between the treatment acetate without local anaesthetic (2); wanted surgical groups of 0.75 (0.42, 1.09) was observed for the pain castration (1); change in family circumstances, which no discomfort scores immediately after injection, in favour longer enabled continuation (1); and a reluctance to of the leuproprelin acetate group. This difference was change from usual treatment (goserelin acetate) (1). statistically significant (Po0.001). Discomfort scores 2 h The data from doses one and two were not used in the after injection also showed leuprorelin acetate injections analysis but are summarised in Table 1. This shows that to be less painful, but this result was not found to be both groups had similarly matched scores for discomfort statistically significant. The results of the supportive analysis were consistent with those given above. A sub- group analysis confirmed the same trend in all T-stage Table 1 Mean discomfort scores groups. Run-in period Period 1 Period 2 Group A Goserelin acetate Leuprorelin (L) Goserelin (G) acetate acetate Conclusion 1.57 0.677 1.213 Group B Goserelin acetate Goserelin (G) Leuprorelin (L) The results of the study found that patients do tolerate acetate acetate leuprorelin acetate better than goserelin acetate, with a 1.53 1.33 0.5 statistically significant difference being observed be- tween the patients’ discomfort immediately after the Table 2 Analysis of variance results Time point Treatment No. Least square (LS) mean Diff (LÀG) (95% Cl) P-value Immediately Leuprorelin 45 0.589 Goserelin 41 1.343 À0.754 (Àl.085, À0.424) o0.001 2 h later Leuprorelin 45 0.388 Goserelin 41 0.579 À0.191 (À0.431, 0.048) 0.114 Prostate Cancer and Prostatic Diseases Tolerability of LHRH analogue administration G Williams et al 189 injection. After receiving leuprorelin acetate, patients relin acetate, and this combined with leuprorelin acetate perceived goserelin acetate injections to be more un- being administered with a smaller needle also raises the comfortable than those who had not experienced the possibility of patient self-administration. comfort of the leuprorelin acetate injection. Additionally, the lowest mean score was recorded immediately after the leuprorelin acetate injections in the arm where patients received four consecutive goserelin acetate References injections first. Only one of the 50 patients dropped out of the study because he did not like to switch between 1 Pienta KJ. Etiology epidemiology, and prevention of carcinoma of the prostate. In: Walsh PC, Retik AB, Darracott Vaughan E, Wein the LHRH analogue therapies, showing an overall AJ, (eds). Campbell’s Urology, (7th edn.) WB Saunders Company, acceptability by the patients of interchanging the two Philadelphia, pp 2489–2496. (1998) treatments. There were also no adverse medical con- 2 The RCR COIN/BAUS Prostate Cancer Working Group. sequences observed in switching treatments. These Guidelines on the management of prostate cancer. BJU Int 84: results confirm the patients’ better tolerance of leupro- 987–1014. (1999) Prostate Cancer and Prostatic Diseases.
Load more

Recommended publications
  • Leuprolide Acetate)
    For Pediatric Use LUPRON® INJECTION (leuprolide acetate) Rx only DESCRIPTION Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin releasing hormone (GnRH or LH-RH). The analog possesses greater potency than the natural hormone. The chemical name is 5- oxo -L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl- N-ethyl-L-prolinamide acetate (salt) with the following structural formula: LUPRON INJECTION is a sterile, aqueous solution intended for daily subcutaneous injection. It is available in a 2.8 mL multiple dose vial containing leuprolide acetate (5 mg/mL), sodium chloride, USP (6.3 mg/mL) for tonicity adjustment, benzyl alcohol, NF as a preservative (9 mg/mL), and water for injection, USP. The pH may have been adjusted with sodium hydroxide, NF and/or acetic acid, NF. CLINICAL PHARMACOLOGY Leuprolide acetate, a GnRH agonist, acts as a potent inhibitor of gonadotropin secretion when given continuously and in therapeutic doses. Animal and human studies indicate that following an initial stimulation of gonadotropins, chronic administration of leuprolide acetate results in suppression of ovarian and testicular steroidogenesis. This effect is reversible upon discontinuation of drug therapy. Leuprolide acetate is not active when given orally. Pharmacokinetics A pharmacokinetic study of leuprolide acetate in children has not been performed. Absorption Page 1 In adults, bioavailability by subcutaneous administration is comparable to that by intravenous administration. Distribution The mean steady-state volume of distribution of leuprolide following intravenous bolus administration to healthy adult male volunteers was 27 L. In vitro binding to human plasma proteins ranged from 43% to 49%.
    [Show full text]
  • CASODEX (Bicalutamide)
    HIGHLIGHTS OF PRESCRIBING INFORMATION • Gynecomastia and breast pain have been reported during treatment with These highlights do not include all the information needed to use CASODEX 150 mg when used as a single agent. (5.3) CASODEX® safely and effectively. See full prescribing information for • CASODEX is used in combination with an LHRH agonist. LHRH CASODEX. agonists have been shown to cause a reduction in glucose tolerance in CASODEX® (bicalutamide) tablet, for oral use males. Consideration should be given to monitoring blood glucose in Initial U.S. Approval: 1995 patients receiving CASODEX in combination with LHRH agonists. (5.4) -------------------------- RECENT MAJOR CHANGES -------------------------- • Monitoring Prostate Specific Antigen (PSA) is recommended. Evaluate Warnings and Precautions (5.2) 10/2017 for clinical progression if PSA increases. (5.5) --------------------------- INDICATIONS AND USAGE -------------------------- ------------------------------ ADVERSE REACTIONS ----------------------------- • CASODEX 50 mg is an androgen receptor inhibitor indicated for use in Adverse reactions that occurred in more than 10% of patients receiving combination therapy with a luteinizing hormone-releasing hormone CASODEX plus an LHRH-A were: hot flashes, pain (including general, back, (LHRH) analog for the treatment of Stage D2 metastatic carcinoma of pelvic and abdominal), asthenia, constipation, infection, nausea, peripheral the prostate. (1) edema, dyspnea, diarrhea, hematuria, nocturia, and anemia. (6.1) • CASODEX 150 mg daily is not approved for use alone or with other treatments. (1) To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca Pharmaceuticals LP at 1-800-236-9933 or FDA at 1-800-FDA-1088 or ---------------------- DOSAGE AND ADMINISTRATION ---------------------- www.fda.gov/medwatch The recommended dose for CASODEX therapy in combination with an LHRH analog is one 50 mg tablet once daily (morning or evening).
    [Show full text]
  • Hormonal Treatment Strategies Tailored to Non-Binary Transgender Individuals
    Journal of Clinical Medicine Review Hormonal Treatment Strategies Tailored to Non-Binary Transgender Individuals Carlotta Cocchetti 1, Jiska Ristori 1, Alessia Romani 1, Mario Maggi 2 and Alessandra Daphne Fisher 1,* 1 Andrology, Women’s Endocrinology and Gender Incongruence Unit, Florence University Hospital, 50139 Florence, Italy; [email protected] (C.C); jiska.ristori@unifi.it (J.R.); [email protected] (A.R.) 2 Department of Experimental, Clinical and Biomedical Sciences, Careggi University Hospital, 50139 Florence, Italy; [email protected]fi.it * Correspondence: fi[email protected] Received: 16 April 2020; Accepted: 18 May 2020; Published: 26 May 2020 Abstract: Introduction: To date no standardized hormonal treatment protocols for non-binary transgender individuals have been described in the literature and there is a lack of data regarding their efficacy and safety. Objectives: To suggest possible treatment strategies for non-binary transgender individuals with non-standardized requests and to emphasize the importance of a personalized clinical approach. Methods: A narrative review of pertinent literature on gender-affirming hormonal treatment in transgender persons was performed using PubMed. Results: New hormonal treatment regimens outside those reported in current guidelines should be considered for non-binary transgender individuals, in order to improve psychological well-being and quality of life. In the present review we suggested the use of hormonal and non-hormonal compounds, which—based on their mechanism of action—could be used in these cases depending on clients’ requests. Conclusion: Requests for an individualized hormonal treatment in non-binary transgender individuals represent a future challenge for professionals managing transgender health care. For each case, clinicians should balance the benefits and risks of a personalized non-standardized treatment, actively involving the person in decisions regarding hormonal treatment.
    [Show full text]
  • Hertfordshire Medicines Management Committee (Hmmc) Nafarelin for Endometriosis Amber Initiation – Recommended for Restricted Use
    HERTFORDSHIRE MEDICINES MANAGEMENT COMMITTEE (HMMC) NAFARELIN FOR ENDOMETRIOSIS AMBER INITIATION – RECOMMENDED FOR RESTRICTED USE Name: What it is Indication Date Decision NICE / SMC generic decision status Guidance (trade) last revised Nafarelin A potent agonistic The hormonal December Final NICE NG73 2mg/ml analogue of management of 2020 Nasal Spray gonadotrophin endometriosis, (Synarel®) releasing hormone including pain relief and (GnRH) reduction of endometriotic lesions HMMC recommendation: Amber initiation across Hertfordshire (i.e. suitable for primary care prescribing after specialist initiation) as an option in endometriosis Background Information: Gonadorelin analogues (or gonadotrophin-releasing hormone agonists [GnRHas]) include buserelin, goserelin, leuprorelin, nafarelin and triptorelin. The current HMMC decision recommends triptorelin as Decapeptyl SR® injection as the gonadorelin analogue of choice within licensed indications (which include endometriosis) link to decision. A request was made by ENHT to use nafarelin nasal spray as an alternative to triptorelin intramuscular injection during the COVID-19 pandemic. The hospital would provide initial 1 month supply, then GPs would continue for further 5 months as an alternative to the patient attending for further clinic appointments for administration of triptorelin. Previously at ENHT, triptorelin was the only gonadorelin analogue on formulary for gynaecological indications. At WHHT buserelin nasal spray 150mcg/dose is RED (hospital only) for infertility & endometriosis indications. Nafarelin nasal spray 2mg/ml is licensed for: . The hormonal management of endometriosis, including pain relief and reduction of endometriotic lesions. Use in controlled ovarian stimulation programmes prior to in-vitro fertilisation, under the supervision of an infertility specialist. Use of nafarelin in endometriosis aims to induce chronic pituitary desensitisation, which gives a menopause-like state maintained over many months.
    [Show full text]
  • Statistical Analysis Plan
    Title: An Open label, Multicenter Study to Assess the Safety and Efficacy of Leuprorelin in the Treatment of Central Precocious Puberty NCT Number: NCT02427958 SAP Approve Date: 01 June 2017 Certain information within this Statistical Analysis Plan has been redacted (ie, specific content is masked irreversibly from view with a black/blue bar) to protect either personally identifiable (PPD) information or company confidential information (CCI). This may include, but is not limited to, redaction of the following: Named persons or organizations associated with the study. Proprietary information, such as scales or coding systems, which are considered confidential information under prior agreements with license holder. • Other information as needed to protect confidentiality of Takeda or partners, personal information, or to otherwise protect the integrity of the clinical study. Takeda Statistical Analysis Plan Leuprorelin-4001 Version: 1.0 An Open label, Multicenter Study to Assess the Safety and Efficacy of Leuprorelin in the Treatment of Central Precocious Puberty Leuprorelin-4001, Leuprorelin in the Treatment of Central Precocious Puberty Statistical Analysis Plan Version: 1.0 Date: 01 June 2017 1 PPD PPD Takeda Statistical Analysis Plan Leuprorelin-4001 Version: 1.0 TABLE OF CONTENTS ABBREVIATIONS ........................................................................................................................ 6 1. INTRODUCTION ...............................................................................................................
    [Show full text]
  • Degarelix for Treating Advanced Hormone- Dependent Prostate Cancer
    CONFIDENTIAL UNTIL PUBLISHED NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE Final appraisal determination Degarelix for treating advanced hormone- dependent prostate cancer This guidance was developed using the single technology appraisal (STA) process 1 Guidance 1.1 Degarelix is recommended as an option for treating advanced hormone-dependent prostate cancer, only in adults with spinal metastases who present with signs or symptoms of spinal cord compression. 1.2 People currently receiving treatment initiated within the NHS with degarelix that is not recommended for them by NICE in this guidance should be able to continue treatment until they and their NHS clinician consider it appropriate to stop. 2 The technology 2.1 Degarelix (Firmagon, Ferring Pharmaceuticals) is a selective gonadotrophin-releasing hormone antagonist that reduces the release of gonadotrophins by the pituitary, which in turn reduces the secretion of testosterone by the testes. Gonadotrophin- releasing hormone is also known as luteinising hormone-releasing hormone (LHRH). Because gonadotrophin-releasing hormone antagonists do not produce a rise in hormone levels at the start of treatment, there is no initial testosterone surge or tumour stimulation, and therefore no potential for symptomatic flares. National Institute for Health and Care Excellence Page 1 of 71 Final appraisal determination – Degarelix for treating advanced hormone-dependent prostate cancer Issue date: April 2014 CONFIDENTIAL UNTIL PUBLISHED Degarelix has a UK marketing authorisation for the ‘treatment of adult male patients with advanced hormone-dependent prostate cancer’. It is administered as a subcutaneous injection. 2.2 The most common adverse reactions with degarelix are related to the effects of testosterone suppression, including hot flushes and weight increase, or injection site reactions (such as pain and erythema).
    [Show full text]
  • Altered Cognitive Function in Men Treated for Prostate
    Altered Cognitive Function in Men Treated for Prostate Cancer with LHRH Analogues and Cyproterone Acetate: A Randomised Controlled Trial H. J. Green PhD1,2, K. I. Pakenham PhD1, B. C. Headley PhD3, J. Yaxley FRACS3, D. L. Nicol FRACS2,4, P. N. Mactaggart FRACS2,5, C. Swanson PhD2, R. B. W atson FRACS6, & R. A. Gardiner MD2,3 1School of Psychology and 2Department of Surgery, The University of Queensland, 3Royal Brisbane, 4Princess Alexandra, 5Queen Elizabeth II & 6Mater Hospitals, Brisbane, Queensland, Australia In conjunction with the Northern Section of the Urological Society of Australasia Correspondence should be addressed to: Dr R. A. Gardiner, Department of Surgery, The University of Queensland, Brisbane, Qld 4072, Australia Fax: +61 7 3365 5559; Phone: +61 7 3365 5233; Email: f.gardiner@ mailbox.uq.edu.au This work was wholly funded by Queensland Cancer Fund. **PREPRINT. Final version published in British Journal of Urology (BJU: International) (2002), 90, 427-432 ** Short Title: COGNITIVE CHANGES W ITH HORMONAL MEDICATION 2 Objective. Luteinising hormone releasing hormone (LHRH) analogues have been associated with memory impairments in women using these drugs for gynaecological conditions. This is the first systematic investigation of the cognitive effects of LHRH analogues in male patients. Methods. 82 men with non-localised prostate cancer were randomly assigned to receive continuous leuprorelin (LHRH analogue), goserelin (LHRH analogue), cyproterone acetate (steroidal antiandrogen) or close clinical monitoring. These patients underwent cognitive assessments at baseline and before commencement of treatment (77) then 6 months later (65). Results. Compared with baseline assessments, men administered androgen suppression monotherapy performed worse in 2/12 tests of attention and memory.
    [Show full text]
  • Goserelin (Zoladex)
    Goserelin (Zoladex) This booklet explains what goserelin is, when it may be prescribed, how it works and what side effects may occur. Goserelin is the generic (non‑branded) name of the drug and how it’s referred to in this booklet. Its current brand name is Zoladex. This information is by Breast Cancer Care. We are the only specialist UK‑wide charity that supports people affected by breast cancer. We’ve been supporting them, their family and friends and campaigning on their behalf since 1973. Today, we continue to offer reliable information and personal support, over the phone and online, from nurses and people who’ve been there. We also offer local support across the UK. From the moment you notice something isn’t right, through to treatment and beyond, we’re here to help you feel more in control. For breast cancer care, support and information, call us free on 0808 800 6000 or visit breastcancercare.org.uk Visit breastcancercare.org.uk 3 What is goserelin? Goserelin is a type of hormone therapy used to treat breast cancer in pre-menopausal women (women who have not been through the menopause). It is given as an injection into the abdomen (belly). It can also be used to try to preserve fertility during chemotherapy (see page 4). Goserelin as a treatment for breast cancer How does it work? Some breast cancers are stimulated to grow by the hormone oestrogen. Before the menopause, oestrogen is mainly produced in the ovaries. Goserelin switches off this production by interfering with hormone signals from the brain that control how the ovaries work.
    [Show full text]
  • Triptorelin, Goserelin and Leuprorelin for Prostate
    789FM.1 GONADORELIN ANALOGUES (GnRHa): TRIPTORELIN, GOSERELIN, LEUPRORELIN FOR PROSTATE CANCER - AMBER RECOMMENDATION GUIDELINE This guideline provides prescribing and monitoring guidance for triptorelin, goserelin and Leuprorelin use in prostate cancer. It should be read in conjunction with the Summary of Product Characteristics (SPC), available on www.medicines.org.uk/emc, and the BNF. BACKGROUND AND INDICATIONS FOR USE There is no conclusive evidence to suggest that any one GnRHa is more effective or has fewer side effects than another for the treatment of prostate cancer.5, 7-9 Available evidence suggests that GnRHa are similar in effectiveness to surgical castration. They have the same licensed indications in the treatment of prostate cancer (Appendix 1). Appendix 2 compares doses, administration frequency and costs.1-4, 9-13 Triptorelin 22.5 mg (six monthly injection) is the 1st choice GnRHa for treatment of metastatic prostate cancer patients on life-long treatment on the Bucks formulary. This is because it is: • Administered via a smaller sized needle (20 gauge) compared to goserelin LA 10.8 mg (14 gauge), thus minimising discomfort to patients.9 • The least expensive in terms of drug and administration costs (Appendix 2).1-4, 9-13 Triptorelin 22.5 mg (six monthly injection) is not preferred in: • Patients newly initiated GnRHa because the first dose should be a monthly preparation (Decapeptyl® SR 3 mg) in order to check that the product is tolerated prior to changing to the six monthly preparation.14 • Anticoagulated patients. This is because triptorelin is an intramuscular (IM) injection. Subcutaneously administered GnRHa (goserelin or leuprorelin) may be preferable.9 RESPONSIBILITIES Hospital specialist 1.
    [Show full text]
  • Systematic Review of Luteinising Hormone-Releasing Hormone Agonists in Adjuvant Therapy of Early Breast Cancer
    Systematic review of luteinising hormone-releasing hormone agonists in adjuvant therapy of early breast cancer Search conducted May–June 2003 Review written June–November 2003 Prepared by Sharma R, Hamilton A, Beith J On behalf of the National Breast Cancer Centre This Systematic review of luteinising hormone-releasing hormone agonists in adjuvant therapy of early breast cancer was prepared by Sharma R, Hamilton A and Beith J on behalf of the National Breast Cancer Centre: 92 Parramatta Road Camperdown, Sydney, Australia Locked Bag 16 Camperdown NSW 1450 Telephone +61 2 9036 3030 Facsimile +61 2 9036 3077 Website www.nbcc.org.au © National Breast Cancer Centre 2004 ISBN Print: 1 74127 019 7 Online: 1 74127 025 1 This work is copyright. Apart from any use as permitted under the Copyright Act 1968, no part may be reproduced by any process without prior written permission from the National Breast Cancer Centre. Requests and enquiries concerning reproduction and rights should be addressed to the Copyright Office, National Breast Cancer Centre, Locked Bag 16 Camperdown NSW 1450 Australia. Website: www.nbcc.org.au Email: [email protected] The conclusions of this systematic review are based on evidence available to November 2003. New data are constantly emerging. The conclusions of this systematic review are likely to change with longer follow-up periods and in light of evidence from other trials. The National Breast Cancer Centre is funded by the Australian Government Department of Health & Ageing 2 Systematic review of luteinising hormone-releasing
    [Show full text]
  • 214621Orig1s000
    CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 214621Orig1s000 MULTI-DISCIPLINE REVIEW Summary Review Office Director Cross Discipline Team Leader Review Clinical Review Non-Clinical Review Statistical Review Clinical Pharmacology Review NDA/BLA Multi-disciplinary Review and Evaluation: NDA 214, 621 Relugolix NDA/BLA Multi-disciplinary Review and Evaluation Disclaimer: In this document, the sections labeled as “The Applicant’s Position” are completed by the Applicant, which do not necessarily reflect the positions of the FDA. Application Type NDA Application Number(s) NDA 214621 Priority or Standard Priority Submit Date(s) April 20, 2020 Received Date(s) April 20, 2020 PDUFA Goal Date December 20, 2020 Division/Office OND/CDER/OOD/DO1 Review Completion Date Established Name Relugolix (b) (4) (Proposed) Trade Name Pharmacologic Class Gonadotropin-releasing hormone (GnRH) receptor antagonist Code name TAK-385 Applicant Myovant Sciences, Inc. Formulation(s) oral tablet Dosing Regimen One time loading dose of 360 mg followed by 120 mg daily Applicant Proposed RELUGOLIX is a gonadotropin-releasing hormone Indication(s)/Population(s) (GnRH) antagonist indicated for the treatment of patients with advanced prostate cancer. Recommendation on Regular approval Regulatory Action Recommended RELUGOLIX is a gonadotropin-releasing hormone Indication(s)/Population(s) (GnRH) antagonist indicated for the treatment of (if applicable) patients with advanced prostate cancer. 1 Version date: January 2020 (ALL NDA/ BLA reviews) Disclaimer: In this document, the sections labeled as “The Applicant’s Position” are completed by the Applicant and do not necessarily reflect the positions of the FDA. Reference ID: 4719259 NDA/BLA Multi-disciplinary Review and Evaluation: NDA 214, 621 Relugolix Table of Contents Reviewers of Multi-Disciplinary Review and Evaluation ..................................................
    [Show full text]
  • 1 SUPPLEMENTARY DATA Draft Medline Search – Pubmed Interface 1# "Puberty"[Mesh] OR (Puberties) OR (Pubertal Maturati
    SUPPLEMENTARY DATA Draft Medline search – PubMed interface 1# "Puberty"[Mesh] OR (Puberties) OR (Pubertal Maturation) OR (Early Puberty) OR "Puberty, Precocious"[Mesh] OR (Precocious Puberty) OR "Precocious Puberty, Central" [Supplementary Concept] OR (Central Precocious Puberty) OR "Sexual precocity" [Supplementary Concept] OR (Idiopathic sexual precocity) OR (Familial precocious puberty) OR (Sexual Precocity) OR "Sexual Maturation"[Mesh] OR (Maturation, Sexual) OR (Maturation, Sex) OR (Sex Maturation) OR "Sexual Development"[Mesh] OR (Development, Sexual) OR (Sex Development) OR (Development, Sex) OR (Gonadal Disorder Maturation) OR (Pubertal Onset) OR "Menstruation Disturbances"[Mesh] OR (Precocious Menses) OR (Early Menses) OR (Early Menarche) OR (Precocious Menarche) OR (Disorders of Puberty) OR (Gonadotropin-Dependent Precocious Puberty) OR (Gonadotropin-Independent Precocious Puberty) OR (Isolated Precocious Thelarche) OR (Isolated Precocious Pubarche) OR (Isolated Precocious Menarche) 2# "Gonadotropin-Releasing Hormone"[Mesh] OR (Gonadotropin Releasing Hormone) OR (Luteinizing Hormone-Releasing Hormone) OR (Luteinizing Hormone Releasing Hormone) OR (GnRH) OR (Gonadoliberin) OR (Gonadorelin) OR (LFRH) OR (LH-FSH Releasing Hormone) OR (LH FSH Releasing Hormone) OR (LH-Releasing Hormone) OR (LH Releasing Hormone) OR (LH-RH) OR (LHFSH Releasing Hormone) OR (Releasing Hormone, LHFSH) OR (LHFSHRH) OR (LHRH) OR (Luliberin) OR (FSH-Releasing Hormone) OR (FSH Releasing Hormone) OR (Gn-RH) OR (Factrel) OR (Gonadorelin Acetate) OR (Kryptocur)
    [Show full text]