Ejaculate volume, an important semen characteristic, plays a significant role in male fertility. There is a growing need to find supplements to increase ejaculate volume. During the etiological screening of male infertility, the role of ejaculate volume as a causative factor is often neglected. The investigational product was also studied for its effect on sexual functioning and sperm characteristics in men with perceived hypospermia.

Confident from conducting high-quality men’s health studies across multiple GCP-compliant sites in the Mumbai metropolitan area, Vedic took on a few more projects. Noteworthy was a study for VigRX Plus, a supplement that was already doing well through e-commerce. Seventy-eight men aged 25–50 years of age, with mild to moderate erectile dysfunction (ED), participated in this RCT. VigRX Plus was well tolerated and more effective than a placebo in improving sexual function in men. The study results were widely viewed online even today, helped the sponsor defend their claims and generate good returns on their study investment. As usual, the study sites and data were monitored by team monitors (clinical research associates) and all trial-related activities audited by an independent quality assurance manager.

There was a dearth of well-designed studies on dietary supplements for sexual function in men. The Vedic team chose the gold standard scales used in sildenafil research to assess two doses of HeezOn for the 4 domains of sexual function viz. libido (arousal), erectile function, ejaculatory function (time to ejaculate) and sexual satisfaction. For the first time, we also evaluated the sexual satisfaction of the female partner for a supplement that was taken by the male volunteers. It was a large triple-blind placebo-controlled study with n=147 completers and required vigilant site training, monitoring, and auditing to ensure compliance and limit bias in the absence of any objective assessments. Both doses of HeezOn were well tolerated and better than placebo in improving several domains of sexual function in middle-aged men. This study gave confidence to a DRTV group to successfully launch their brand through TV infomercials in the US in an otherwise controversial category full of unsubstantiated claims.

The study included men with an American Urological Association Symptom Index (AUASI) score of ≥ 13 and finally, 60 completers were assessed at the end of 8 weeks also for post voiding urine, prostate size, serum testosterone, and DHT. Significant improvement of obstructive symptoms and better management of irritable BPH symptoms were achieved in all groups after treatment. The sponsor of this study was Frutarom with worldwide sales of its functional ingredients. Hence, the study was completed to comply with ICH-GCP guidelines and other applicable regulations for human biomedical research to make study results globally acceptable.