PMID- 28225313
OWN - NLM
STAT- MEDLINE
DCOM- 20170710
LR  - 20210204
IS  - 1530-891X (Print)
IS  - 1530-891X (Linking)
VI  - 23
IP  - 5
DP  - 2017 May
TI  - EFFICACY AND SAFETY OF A NEW TOPICAL TESTOSTERONE REPLACEMENT GEL THERAPY FOR THE 
      TREATMENT OF MALE HYPOGONADISM.
PG  - 557-565
LID - 10.4158/EP161665.OR [doi]
AB  - 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 (C(ave (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 C(ave) 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 
      C(ave) between 300 and 1,050 ng/dL with Tgel. Symptoms of testosterone deficiency 
      improved with few safety concerns. ABBREVIATIONS: AE = adverse event C(ave(0-24)) 
      = average testosterone concentration CI = confidence interval C(max) = maximum 
      concentration IIEF = International Index of Erectile Function MAF = 
      Multidimensional Assessment of Fatigue PK = pharmacokinetic PSA = 
      prostate-specific antigen SAE = serious adverse event SF-12 = Short Form 12 
      Health Survey Tgel = testosterone gel 2% T(max) = time to achieve maximum 
      concentration TRT = testosterone replacement therapy.
FAU - Cunningham, Glenn
AU  - Cunningham G
FAU - Belkoff, Laurence
AU  - Belkoff L
FAU - Brock, Gerald
AU  - Brock G
FAU - Efros, Mitchell
AU  - Efros M
FAU - Gittelman, Marc
AU  - Gittelman M
FAU - Carrara, Dario
AU  - Carrara D
FAU - Neijber, Anders
AU  - Neijber A
FAU - Ando, Masakazu
AU  - Ando M
FAU - Mitchel, Jules
AU  - Mitchel J
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
DEP - 20170222
PL  - United States
TA  - Endocr Pract
JT  - Endocrine practice : official journal of the American College of Endocrinology 
      and the American Association of Clinical Endocrinologists
JID - 9607439
RN  - 0 (Gels)
RN  - 3XMK78S47O (Testosterone)
SB  - IM
MH  - Administration, Cutaneous
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Gels
MH  - *Hormone Replacement Therapy/adverse effects/methods
MH  - Humans
MH  - Hypogonadism/*drug therapy/metabolism
MH  - Male
MH  - Middle Aged
MH  - Testosterone/*administration & dosage/*adverse effects/pharmacokinetics
MH  - Treatment Outcome
MH  - Young Adult
EDAT- 2017/02/23 06:00
MHDA- 2017/07/14 06:00
CRDT- 2017/02/23 06:00
PHST- 2017/02/23 06:00 [pubmed]
PHST- 2017/07/14 06:00 [medline]
PHST- 2017/02/23 06:00 [entrez]
AID - S1530-891X(20)48307-7 [pii]
AID - 10.4158/EP161665.OR [doi]
PST - ppublish
SO  - Endocr Pract. 2017 May;23(5):557-565. doi: 10.4158/EP161665.OR. Epub 2017 Feb 22.