Clomiphene citrate and testosterone gel replacement therapy for male hypogonadism: efficacy and treatment cost.

[David Morris]

http://www.ncbi.nlm.nih.gov/pubmed/19694928

J Sex Med. 2010 Jan;7(1 Pt 1):269-76. Epub 2009 Aug 17.

Clomiphene citrate and testosterone gel replacement therapy for male
hypogonadism: efficacy and treatment cost.
Taylor F, Levine L.

Rush University Medical Center-Department of Urology, Chicago, IL,
USA. frederick_taylor at rush.edu

Abstract
INTRODUCTION: The efficacy of oral clomiphene citrate (CC) in the
treatment of male hypogonadism and male infertility (MI) with low
serum testosterone and normal gonadotropin levels has been reported.

AIM: The aim of this article is to evaluate CC and testosterone gel
replacement therapy (TGRT) with regard to biochemical and clinical
efficacy and cost.

MAIN OUTCOME MEASURES: The main outcome measures were change in serum
testosterone with CC and TGRT therapy, and change in the androgen
deficiency in aging male (ADAM) questionnaire scores with CC therapy.

METHODS: Men receiving CC or TGRT with either Androgel 1% or Testim 1%
for hypogonadism (defined as testosterone < 300 ng/mL) or MI were
included. Serum values were collected 1-2 months after treatment
initiation and semi-annually thereafter. Retrospective data collection
was performed via chart review. Subjective follow up of patients
receiving CC was performed via telephone interview using the ADAM
questionnaire.

RESULTS: A hundred and four men (65 CC and 39 TGRT) were identified
who began CC (50 mg every other day) or TGRT (5 g). Average age
(years) was 42(CC) vs. 57 (TGRT). Average follow up was 23 months (CC,
range 8-40 months) vs. 46 months (TGRT, range 6-149 months). Average
posttreatment testosterone was 573 ng/dL in the CC group and 553 ng/dL
in the TGRT group (P value < 0.001). The monthly cost of Testim 1% (5
gm daily) is $270, Androgel 1% (5 gm daily) is $265, and CC (50 mg
every other day) is $83. Among CC patients, the average pretreatment
ADAM score was 4.9 vs. 2.1 at follow up (P < 0.05). Average
pretreatment ADAM sexual function domain score was 0.76 vs. 0.23 at
follow up (P < 0.05). There were no adverse events reported.

CONCLUSION: CC represents a treatment option for men with
hypogonadism, demonstrating biochemical and clinical efficacy with few
side effects and lower cost as compared with TGRT.