The effects of androxal on sperm production

The aim of this study was to determine the effects of androxal 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 androxal is not only no worse than topical gels, but also keeps sperm counts within normal ranges.

Subjects will be randomly assigned to one of two treatment groups, using a block size of 4. The order in which treatments are assigned in each block is random, and the process is repeated for successive blocks of subjects until all subjects have been randomized. This process ensures that every four randomized subjects are followed by an equal number of subjects in each treatment group.

Once the target 50 subjects are included, 75 randomisation codes will be generated in order to allow subjects to be screened, taking into account drop-outs. When subjects are enrolled in the study, they will be assigned a unique sequential number starting with 001. At least 50 participants meeting all inclusion criteria will be randomly assigned 1:1, with approximately 25 participants assigned to the Androxal treatment group and approximately 25 participants assigned to the placebo group.

Placebo-controlled studies are the gold standard of clinical trials and should be attempted where indications and current medical practice allow. The study is investigating a product that improves sperm concentration in subjects with idiopathic male infertility and secondary hypogonadism with low testosterone. Idiopathic male infertility subjects do not need treatment to stay healthy, and taking a placebo for about 18 weeks is unlikely to cause any harm to the subjects. Today, the standard of care for idiopathic male infertility allows subjects and physicians to opt out of medical treatment. Therefore, the use of placebo controls in this study is justified and will provide the best mechanism for evaluating the effects of treatment.