This was a post-hoc analysis of a randomized, placebo-controlled trial; the design of the parent trial has been previously described (15 (link),16 (link)). All subjects received goserelin acetate (Zoladex, provided by AstraZeneca) 3.6 mg subcutaneously at baseline and every 4 weeks throughout the study in order to suppress endogenous production of testosterone and estradiol, as well as anastrazole (Arimidex, provided by AstraZeneca) 1 mg daily in order to inhibit the aromatization of testosterone to estradiol. Subjects were randomly assigned to one of five testosterone replacement doses: 0 g (placebo gel), 1.25 g, 2.5 g, 5 g, or 10 g of a topical 1% testosterone gel (AndroGel, provided by AbbVie Inc.) daily. Originally, 202 men were enrolled and underwent randomization. 161 men completed the week 12 visit (15 (link)). NT-proBNP levels were available at week 0 (baseline, prior to receiving any study medications) and week 12 in 151 subjects. Because our primary endpoint was NT-proBNP levels, only those 151 subjects with NT-proBNP levels available at both baseline and week 12 are included in the analysis. The group of 151 subjects had similar baseline clinical characteristics and hormone levels as the entire cohort that underwent randomization.
Arimidex
Manufactured by AstraZeneca
Sourced in United Kingdom
Arimidex is a pharmaceutical product manufactured by AstraZeneca. It is a selective aromatase inhibitor, a type of medication used to treat certain types of breast cancer in postmenopausal women.
Automatically generated - may contain errors
3 protocols using arimidex
1
Testosterone Replacement Dose Effects on Cardiac Biomarkers
2
Adjuvant Endocrine Therapy and Diuretics
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Enrolled patients continued treated with the standard-dose of a third-generation AI; 1 mg Anastrozole (Arimidex; AstraZeneca Pharmaceuticals), 25 mg Exemestane (Aromasin; Pfizer), or 2.5 mg Letrozole (Femara; Novartis) orally daily. Patients who had been taking a stable dose of medication for treatment of pain (eg, nonsteroidal anti-inflammatory medications, cyclooxygenase-2 inhibitors and acetaminophen), and/or bisphosphonates every 6 month at the time of enrollment were permitted to continue the medication. Lasilactone® 50 mg; (produced by: Sanofi Aventis Egypt s.a.e. Under Licence of: Sanofi Aventis/ Germany) an oral combination of Frusemide 20 mg/Spironolactone 50 mg in a film-coated tablet, was coadministrated every other day with breakfast for 4 weeks. Patients were also instructed to avoid taking concomitant medications with the potential to interact with Lasilactone® as described in the package insert.
3
Neoadjuvant Endocrine Therapy Comparison
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This was a non-comparative multicentre randomised phase II study in which patients from three French centres were randomly assigned in a 1 : 1 ratio to receive either 1 mg per day anastrozole administered orally for 6 months (control arm) or 500 mg of fulvestrant administered as an intramuscular infusion every 4 weeks for 6 months with a loading dose in the first month (experimental arm). Anastrozole (ARIMIDEX, Astra Zeneca, London, UK) was provided as 1 mg film-coated tablets. Fulvestrant (FASLODEX, Astra Zeneca) was provided as a 250 mg/5 ml solution. Before starting treatment, three trucut biopsies were taken for research purposes; two were frozen and one was fixed in Molecular Fixative (Hostein et al, 2011 (link)). Follow-up was carried out at 2, 4 and 6 months to assess the clinical response and tolerance. Drug treatment was continued until the day before surgery. Surgery at 6 months was proposed to all patients. The decision for breast-conserving surgery or total mastectomy at the end of neoadjuvant endocrine treatment was assessed by a multidisciplinary board comprising a medical oncologist, a surgeon and a radiation oncologist. After 6 months of treatment, residual tumour was resected surgically, and frozen and formalin-fixed samples were again taken for research purposes. Adjuvant treatments were decided according to each centre's policy.
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