Androxal and male infertility
This was an exploratory, single-center, randomized, parallel, double-blind placebo and active controlled trial in adult men aged 18 to 35 years with unexplained male infertility. Approximately 50 men will be randomly assigned to one of the two treatment groups in a 1:1 ratio. About half of the men will receive 25mg of Androxal and half will receive a placebo (inactive pill) for 16 weeks. The study will last about four months and involve up to seven visits.
The aim of this study was to determine the effects of androl on sperm production.
An estimated 4 to 5 million men in the United States are testosterone deficient, but less than 10% currently receive testosterone replacement therapy. There are many reasons why the number of men receiving testosterone replacement therapy is low, one of which is the route of administration. Currently approved androgen therapies include oral products, injections, patches, oral systems, and gels, each of which has drawbacks. Oral preparations may be associated with hepatotoxicity and have adverse effects on lipid and carbohydrate metabolism. The injections have been linked to uneven serum testosterone levels, leading to fluctuations in mood, libido and energy levels. The patch may require invasive preparation, cause skin irritation, or fail to adhere properly. Testosterone gels have overcome some of the above issues and have gained acceptance, but there are signs that men are not using the gel properly.
Previous studies have shown that Androxal significantly increases total testosterone levels in men with low baseline values. Other studies have found that androl is not only no worse than topical gels, but also keeps sperm counts within normal ranges.
