Enovate Biolife Pvt Ltd.

Acute Stage: The present study is a randomized, double-blind, placebo-controlled, single-dose, 4-way, cross-over, study. Approximately not more than 170 individuals will be screened and considering a screening failure rate of 25%, approximately 128 individuals will be randomized in a ratio of 1:1:1:1 to receive one of the IPs and will be assigned a unique randomization code. In this stage, approximately 114 individuals will complete the study, after accounting for a dropout/withdrawal rate of 15%. The intervention duration is 4 days [1 (single dose) x 4 periods].
Sub-Acute Stage: The present study is a randomized, double-blind, placebo-controlled, 4 arms, parallel study. In this stage, approximately 112 individuals will be re-randomized in a ratio of 1:1:1:1 to receive one of the IPs and will be assigned a unique randomization code. Each group will have not less than 24 completed participants after accounting for a dropout/withdrawal rate of 15%. The intervention duration is 28 days.

Sexual function is a part of a normal healthy life and considered to be essential for mental, physical and marital well-being. Any derangement in normal function though is a distressing situation for the individual, is often not reported due to embarrassment or due to social stigma. Sexual disorders in men are categorized according to the stage of sexual response affected in terms of disorders of erectile function, ejaculatory function or libido, albeit there is considerable potential for overlap amongst the disorders. The use of current intervention has many side-effects and has been prohibited in cardiovascular condition and also to be taken with caution with other medical condition.
This has led to the development of multiple alternate therapies which are helpful for a limited number of cases but the major concern for all these therapies is their late onset of action and not having a sustained effect.