title: Efficacy and safety of testosterone replacement gel for treating hypogonadism in men: Phase III open-label studies.
abstract: Efficacy and safety of testosterone gel 2% (TG) were evaluated in two phase 3, open-labelled, single-arm, multicentre studies (000023 and extension study 000077). Hypogonadal men having serum testosterone levels <300 ng/dl at two consecutive measurements were included. Study duration was 9 months (000023: 3 months; 000077: 6 months). Starting dose of TG (46 mg) was applied on upper arm/shoulder. The primary endpoint (000023) was responder rate (subjects with average 24-hour serum testosterone concentration 300-1050 ng/dl on Day 90). Study 000077 evaluated the safety of TG in patients rolling over from study 000023 over a period of 6 months. Of 180 subjects in 000023, 172 completed and 145 rolled over to 000077, with 127 completers. The responder rate was 85.5%. Fewer subjects in 000077 (12.7%) versus 000023 (31.8%) had maximum testosterone concentration (Cmax) >1500 ng/dl, with no significant safety concerns. Significant improvements in sexual function and quality of life were noted in both studies. Subjects experienced few skin reactions without notable increases in prostate-specific antigen and haematocrit levels. TG was efficacious with an acceptable safety profile. Cmax>1500 ng/dl did not exhibit distinct impact on safety parameters. However, further optimisation of titration schema to reduce Cmaxis warranted while maintaining the average steady state total testosterone concentration.
authors.affiliation: Urologic Consultants of Southeastern Pennsylvania, Bala Cynwyd, PA, USA.
authors.forename: L
authors.initials: L
authors.lastname: Belkoff
authors.affiliation: Division of Urology, Department of Surgery, Western University, London, ON, Canada.
authors.forename: G
authors.initials: G
authors.lastname: Brock
authors.affiliation: Ferring Galenisches Labor AG, Gewerbestrasse, Allschwil, Switzerland.
authors.forename: D
authors.initials: D
authors.lastname: Carrara
authors.affiliation: International Pharma Science Center, Ferring Pharmaceuticals, Copenhagen, Denmark.
authors.forename: A
authors.identifier: http://orcid.org/0000-0002-4516-3618
authors.initials: A
authors.lastname: Neijber
authors.affiliation: Ferring International PharmaScience Center US Inc., Parsippany, NJ, USA.
authors.forename: M
authors.initials: M
authors.lastname: Ando
authors.affiliation: Target Health Inc, New York, NY, USA.
authors.forename: J
authors.initials: J
authors.lastname: Mitchel
mesh_terms: D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D000368:Aged; D000728:Androgens / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D020249:Hormone Replacement Therapy / Q000009:adverse effects*; D006801:Humans; D007006:Hypogonadism / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D013739:Testosterone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000728:Androgens; D013739:Testosterone
keywords: androgen deficiency; hypogonadism; prostate-specific antigen; quality of life; sexual functioning; testosterone