A Clinical Study to Evaluate the Safety and Effectiveness of a New Treatment for Mens Sexual Health

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2026
INTERVENTION: CONDITION: Health Condition 1: N529‐ Male erectile dysfunction, unspecified PRIMARY OUTCOME: International Index of Erectile Function ; Premature Ejaculation Diagnostic Tool score ; Semen Analysis ; Timepoint: FROM 0 ‐ 60 DAYS SECONDARY OUTCOME: Hormonal Assessment Total Testosterone, Free Testosterone, LH, FSH and prolactin.Timepoint: FROM 0 ‐ 60 DAYS INCLUSION CRITERIA: Male married participants aged 21 to 60 years. Participants presenting with complaints related to impaired male sexual wellness such as reduced sexual desire, erectile difficulty, or reduced sexual satisfaction. IIEF 15 score between 11 and 16 indicating moderate sexual dysfunction. Participants in a stable heterosexual relationship for at least 6 months. Normal baseline hematological and biochemical parameters or values within acceptable clinical limits. Willing to abstain from other medications or supplements that may affect sexual function during the study period, follow study instructions, and attend all scheduled visits. Written informed consent obtained before participation. Willing to use condoms as a contraceptive method during the study period.
Epistemonikos ID: 9ac743bba364851c838e82e56a2888a78ffe8663
First added on: Oct 08, 2026