Duratia 60 mg is a brand of dapoxetine, a medicine used for treating premature ejaculation. It was not tested in separate “Duratia-specific” clinical trials. Instead, its approval and use are based on large international clinical trials conducted on the active ingredient dapoxetine itself (30 mg and 60 mg doses).
Key Clinical Trials for Dapoxetine (basis of Duratia 60 mg)
1. Phase III Randomized Controlled Trials
The main evidence comes from five large Phase III clinical trials conducted across over 25 countries:
Included around 6,000+ men with premature ejaculation
Compared dapoxetine 30 mg and 60 mg vs placebo
Duration: 9 to 24 weeks
2. Integrated Phase III Analysis
A pooled analysis of these trials showed:
Significant increase in intravaginal ejaculatory latency time (IELT) with 60 mg dapoxetine vs placebo
Improvement in sexual satisfaction and control over ejaculation
3. Major Multinational RCTs
One key study conducted in 22 countries found:
Consistent improvement over placebo across all endpoints
4. Meta-analyses of Multiple Trials
Systematic reviews confirm:
Both 30 mg and 60 mg doses significantly outperform placebo
60 mg provides greater improvement in ejaculation delay than 30 mg
Important Clarification
Duratia is only a brand name
It was not independently tested in separate clinical trials
All evidence comes from dapoxetine global clinical trial programs
DURATIA 60 MG is supported by large-scale, multi-country Phase III randomized controlled trials of dapoxetine, involving thousands of participants. These studies consistently show that the 60 mg dose improves ejaculation control and sexual satisfaction compared to placebo, forming the scientific basis for its use.
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