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[joniiiscosttale]

Duratia 60 mg contains the active ingredient dapoxetine and is primarily used to treat premature ejaculation (PE) in men. Clinical trials evaluating the efficacy and safety of Duratia 60 mg have been conducted to assess its effectiveness in improving ejaculatory control and its safety profile. While I can't provide specific details on all clinical trials, I can outline the general process and key findings.

Clinical trials for Duratia 60 mg typically involve several phases, including:

Phase I Trials: These trials evaluate the pharmacokinetics, pharmacodynamics, and safety of the medication in healthy volunteers. Phase I trials help determine the appropriate dosage range and identify potential side effects.

Phase II Trials: Phase II trials involve a larger group of individuals with premature ejaculation to further evaluate the efficacy and safety of Duratia 60mg. These trials may include dose-ranging studies to determine the optimal dosage for further testing.

Phase III Trials: Phase III trials are large-scale studies that aim to confirm the efficacy and safety of Duratia 60 mg in a broader population of men with premature ejaculation. These trials typically compare Duratia 60 mg to a placebo or other treatments for premature ejaculation.

Key findings from clinical trials evaluating Duratia 60 mg may include:

Improvement in Intravaginal Ejaculatory Latency Time (IELT): Clinical trials have shown that Duratia 60 mg can significantly increase IELT, which is the time from vaginal penetration to ejaculation, compared to placebo.

Improvement in Patient-Reported Outcomes: Duratia 60 mg has been shown to improve patient-reported outcomes related to satisfaction with sexual intercourse, control over ejaculation, and overall sexual functioning.

Safety Profile: Clinical trials have demonstrated that Duratia 60 mg is generally well-tolerated, with most adverse effects being mild to moderate in severity. Common side effects may include nausea, headache, dizziness, and diarrhea.

It's important to note that specific details and results from clinical trials may vary depending on the study design, patient population, and other factors. Healthcare providers rely on the collective evidence from clinical trials to make informed decisions about prescribing Duratia 60 mg for premature ejaculation.