Journal article
EFFICACY AND SAFETY OF A NEW TOPICAL TESTOSTERONE REPLACEMENT GEL THERAPY FOR THE TREATMENT OF MALE HYPOGONADISM
Endocrine practice, v 23(5), pp 557-565
01 May 2017
PMID: 28225313
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
Objective: Testosterone replacement therapy is indicated for male hypogonadism. This study aimed to evaluate the efficacy and safety of testosterone gel 2% (Tgel) over 90 days.
Methods: This phase 3, open-label, noncomparator study was conducted in adult hypogonadal men (2 consecutive fasting serum testosterone values < 300 ng/ dL and > 86% subjects with symptoms consistent with testosterone deficiency). Subjects applied Tgel 23 mg/day (single pump-actuation using a hands-free cap applicator). The dose was uptitrated to 46 mg/day after 2 weeks if the 4-hour serum total testosterone level was < 500 ng/dL. The dose could be further up-or downtitrated to 23, 46, and 69 mg on Days 21, 42, and 63. The primary endpoint included the percentage of subjects with average testosterone concentration (Cave (0-24)) between 300 and 1,050 ng/dL on Day 90. Safety endpoints were adverse events (AEs), laboratory parameters, and vital signs.
Results: Of the 159 who enrolled, 139 men completed the study. Approximately three-quarters (76.1%) of subjects met Cave criteria on Day 90. Most AEs were mild to moderate. There were 5 serious AEs, and 1 (myocardial infarction) was judged as possibly related to Tgel. Confirmed excessive increases in prostate-specific antigen or hematocrit levels were rare. Tgel had a favorable local skin tolerability profile.
Conclusion: Overall, 76% of subjects achieved Cave between 300 and 1,050 ng/dL with Tgel. Symptoms of testosterone deficiency improved with few safety concerns.
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Details
- Title
- EFFICACY AND SAFETY OF A NEW TOPICAL TESTOSTERONE REPLACEMENT GEL THERAPY FOR THE TREATMENT OF MALE HYPOGONADISM
- Creators
- Glenn Cunningham - St. Luke's HospitalLaurence Belkoff - Urology AssociatesGerald Brock - Western UniversityMitchell Efros - Accumed Research AssociatesMarc Gittelman - Aventura Hospital and Medical CenterDario Carrara - LaborAnders Neijber - Ferring PharmaceuticalsMasakazu Ando - Ferring Int PharmaScience Ctr US, Parsippany, NJ USAJules Mitchel - Target
- Publication Details
- Endocrine practice, v 23(5), pp 557-565
- Publisher
- Amer Assoc Clinical Endocrinologists
- Number of pages
- 9
- Grant note
- Ferring; Ferring Pharmaceuticals Ferring Pharmaceuticals
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Surgery
- Web of Science ID
- WOS:000411106500005
- Scopus ID
- 2-s2.0-85022347238
- Other Identifier
- 991021916799304721
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- Collaboration types
- Industry collaboration
- Domestic collaboration
- International collaboration
- Web of Science research areas
- Endocrinology & Metabolism