Impact of Testosterone Solution 2% on Ejaculatory Dysfunction in Hypogonadal Men
Mario Maggi MD; Darell Heiselman, DO; Jack Knorr PhD; Smriti Iyengar PhD; Darius A. Paduch MD, PhD; Craig F. Donatucci, MD
ONLINE: August 2016 – The Journal of Sexual Medicine
Introduction and Aims
Hypogonadism – low testosterone in men – is associated with a number of men’s health issues, including erectile dysfunction (ED), lower libido, fatigue, increased body fat, decreased bone density, and decreased body mass. The condition can may also raise man’s risk for ejaculatory dysfunction.
Testosterone solution 2% is often prescribed to treat testosterone deficiency. This study aimed to determine whether testosterone replacement therapy could improve ejaculatory function in men with hypogonadism.
Seven hundred fifteen men with a mean age of 55 participated in the study. All of the men had low total testosterone levels, defined as levels below 300 ng/dL. Eighty percent of the men were less than 65 years old and 79% were white. About three-quarters of them reported decreased sex drive and low energy. Six hundred patients were sexually-active; about 80% of those men had some degree of ED.
Main Outcome Measures
The following questionnaires were used:
• International Index of Erectile Function (IIEF) – This tool is designed to assess five domains: erectile function, sexual desire, intercourse satisfaction, orgasmic function, and overall satisfaction.
• Men’s Sexual Health Questionnaire, Ejaculatory Dysfunction, Short Form (MSHQ-EjD-SF) – The first three items of this four-item questionnaire addresses the frequency of ejaculation with sexual activity, perceived strength and volume of ejaculate, and degree of bother perceived by patients.
The fourth question evaluates how bothered a man might be by any ejaculatory difficulties.
This was a multicenter, randomized, double-blinded placebo-controlled, parallel group study that lasted 16 weeks. The first 4 weeks involved screening; the following 12 weeks comprised the treatment period.
The men were randomized to receive either testosterone treatment (358 men) or placebo (357 men). Testosterone deficiency was verified for all men using two measurements taken at least one week apart.
Men in the testosterone group applied the treatment to their axillae once a day. Doses started at 60 mg for each day but were adjusted as needed.
Based on results from the first three MSHQ-EjD-SF items, the men in the testosterone group had improved ejaculatory function compared to the placebo group. In terms of bother, however, the difference between the groups’ answers to the fourth MSHQ-EjD-SF item was not statistically significant.
About 41% of the men had a treatment-emergent adverse event, however minor. The following events were reported by at least 1% of men in the testosterone group, with lower incidence rates in the placebo group:
• Increased hematocrit
• Upper respiratory tract infection
• Burning sensation
• Increased prostate-specific antigen
Seven patients in the testosterone group (1.98%) and 11 patients in the placebo group (3.09%) left the study because of at least one adverse event.
The authors discussed their finding on the “bother” question of the MSHQ-EjD-SF, which was not statistically significant. They pointed out that baseline levels on the MSHQ-EjD-SF were low to begin with, indicating less bother and “very little room for improvement.” They added that the MSHQ-EjD-SF was designed for patients taking α-blockers, not men with hypogonadism. “Better tools might be needed to measure bother score changes in non-erectile sexual dysfunction,” they wrote.
They also acknowledged the following limitations:
• Ejaculatory dysfunction was not an inclusion criterion.
• The 12-week trial period was short and long-term outcomes cannot be evaluated.
• Neither of the questionnaires used have been validated to assess changes in orgasmic and ejaculatory function in hypogonadal men.
• Some men may have used α1-adrenergic antagonists, which could have affected ejaculatory function.
Overall, the authors concluded: “In this multicenter, double-blinded, placebo-controlled study of testosterone replacement therapy, testosterone solution 2% effectively improved ejaculatory function in androgen-deficient men, although there was no statistically significant difference in bother.”