Efficacy and Safety of Avanafil in the Patients With Erectile Dysfunction
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an exploratory clinical study to presume the optimum usage and dosage for a
      therapeutic confirmatory study by evaluating the efficacy and safety of Avanafil 50mg, 100mg,
      200mg or placebo administered orally in patients with erectile dysfunction. In conclusions,
      Patients with erectile dysfunction (ED) were administered placebo, Avanafil 50mg, 100mg or
      200mg 30 minutes before sexual intercourse for 8 weeks.
    

Detailed description: 
      1. Study design: Prospective, randomized, double blind, placebo-controlled, therapeutic
      exploratory clinical study Usage & period One capsule was administered 30minutes before
      sexual intercourse.It was administered only once a day.

      [Evaluation endpoints]

        1. Safety: ① Laboratory tests: Hematological Test, Blood chemical Test, Urinalysis Vital
           signs: blood pressure, pulse rate ③ Adverse events and Adverse drug reaction ④12-lead
           ECG

        2. Efficacy

             -  Primary endpoint ▪ The change of erectile function (EF) domain score in the
                international index of erectile function (IIEF)

             -  Secondary endpoint ▪ The change of success rate in sexual encounter profile (SEP)
                questionnaire 2, questionnaire 3, questionnaire 4 and questionnaire 5 ▪ The change
                of score in IIEF questionnaire 3 and questionnaire 4, The change of score in other
                domains of IIEF, GEAQ (Global efficacy assessment question), Normal erectile
                function (IIEF EF domain score ≥ 26) rate Statistical methods

                  1. Definition of Evaluation population Maximum efficacy evaluation population
                     included the subjects who satisfied inclusion criteria, who took the
                     investigational product at least once, who visited the hospital after taking
                     the investigational product, and who got the result of efficacy evaluation.
                     Safety-Evaluation Population consisted of the subjects who made a visit after
                     taking the investigational product once or more and who got follow-up safety
                     results

                  2. Initial Comparability Discrete variables were comparatively analyzed by
                     χ2-test, Fisher's exact test, and Successive variables were comparatively
                     analyzed by ANOVA test or Kruskal-Wallis test.

                  3. Efficacy Evaluation The change of EF domain score in the IIEF: Analysis of
                     covariance(ANCOVA), in which baseline was corrected, was performed to check
                     whether there was a difference between the placebo group and the Avanafil
                     groups in change of EF domain score.

                     The change of score in other domains of IIEF: Analysis of covariance(ANCOVA),
                     in which baseline was corrected, was performed to check whether there was a
                     difference between the placebo group and the Avanafil groups.

                     The change of score in IIEF questionnaire 3 and questionnaire 4: Analysis of
                     covariance(ANCOVA), in which baseline was corrected, was performed to check
                     whether there was a difference between the placebo group and the Avanafil
                     groups in IIEF questionnaire 3, questionnaire 4 respectively.

                     The change of success rate in SEP questionnaire 2, questionnaire 3,
                     questionnaire 4 and questionnaire 5: Analysis of covariance(ANCOVA), in which
                     baseline was corrected, was performed to check whether there was a difference
                     between the placebo group and the Avanafil groups.

                     GEAQ (Global Efficacy Assessment Question) : The difference of GEAQ between
                     groups was analyzed by χ2-test.

                     Normal erectile function(IIEF EF domain score ≥ 26) rate: The difference of
                     Normal erectile function rate between groups was analyzed by χ2-test.

                     The efficacy results were analyzed by Dunnett's or Bonferroni's multiple
                     comparison test to check whether there was a significant difference between
                     the placebo group and the Avanafil groups.

                  4. Safety Evaluation Adverse Events and Adverse Drug Reaction: The difference
                     between the placebo group and the Avanafil groups was compared by using
                     χ2-test or Fisher's exact test. Adverse events reported in study subjects were
                     presented by WHOART (World Health Organization Adverse Reaction Terminology)
                     system organ class. The adverse drug reactions, related with the
                     investigational product, were comparatively verified on the same method.

      All statistical analyses were performed under significance level 5%, test power 80% and
      two-side test.
    

Intervention name(s): Avanafil; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): One capsule should be taken with water, 30 minutes before sexual intercourse. It should be taken only once a day.
Intemperance in eating and drinking should not be done, 2 hours before and 2 hour after taking the investigational product.
Investigational products were administered prior to the sexual intercourse for total 8 weeks.; One capsule should be taken with water, 30 minutes before sexual intercourse. It should be taken only once a day.
Intemperance in eating and drinking should not be done, 2 hours before and 2 hour after taking the placebo.
Placebos were administered prior to the sexual intercourse for total 8 weeks.
Other intervention name(s): Phosphodiesterase 5 inhibitor
Intervention MeSH terms: Phosphodiesterase 5 Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment