Clinical Study of Tadaflexe (Tadalafil 10 mg) Oral Gel Sachet in Yemeni Honey in Patients with Erectile Dysfunction

Abstract

Introduction: Erectile dysfunction (ED) is a common issue impacting millions of men around the globe, with notable effects on both life quality and mental health. This clinical trial evaluated the clinical efficacy, onset of action, safety, and patient satisfaction of Tadaflexe (Tadalafil 10 mg) formulated as an oral gel in Yemeni honey sachets. The formulation was designed to enhance absorption and provide a natural delivery vehicle for Tadalafil, a selective phosphodiesterase type 5 inhibitor used for erectile dysfunction (ED). This study aimed to assess the effectiveness, safety, and tolerability of Seldiflexe, which is a new oral gel sachet formulation of Tadaflexe (Tadalafil 10 mg) with 5 g of Yemeni honey, in comparison with standard Tadalafil 10 mg tablets.

Materials and methods: A randomized, double-blind, controlled trial was carried out with 80 male participants who had been diagnosed with erectile dysfunction (ED). Subjects were divided into two groups: the Tadaflexe (Tadalafil 10 mg) oral gel sachet group A (n = 40) and the standard Tadalafil 10 mg tablet group B (n = 40) for a duration of 4 weeks. The main measures included changes in the scores of the International Index of Erectile Function (IIEF), time until effects began, and the profile of any adverse events.

Results: The analysis revealed a statistically significant improvement in erectile function scores post-treatment with Tadaflex oral gel. The onset of action was notably faster compared to standard Tadalafil tablets. Adverse effects were minimal, and overall satisfaction was high among participants. The time it takes for Tadaflexe (Tadalafil 10 mg) in Yemeni honey oral gel sachet to start working is 22.5 ± 4.2 minutes, which is significantly faster than Tadalafil 10 mg tablets was 38.7 ± 5.6 minutes at p < 0.001. However, after four weeks, there was no significant difference in the IIEF scores between Tadaflexe oral gel (20.1 ± 2.8) and Tadalafil tablets (18.2 ± 3.1) were significantly different at p < 0.05. On the other hand, the adverse effects were significantly less with Tadaflexe oral gel sachet as compared with Tadalafil tablets.

Conclusion: The study demonstrated a significantly faster onset of action, excellent tolerability, and improved patient preference compared with conventional tablet formulations.