The Safety of Dapoxetine/Tadalafil Combination Therapy
|ClinicalTrials.gov Identifier: NCT03177746|
Recruitment Status : Active, not recruiting
First Posted : June 6, 2017
Last Update Posted : October 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Premature Ejaculation Erectile Dysfunction Safety Issues||Drug: Dapoxetine/Tadalafil 30/20 mg film coated tablet||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Safety of Dapoxetine/Tadalafil Combination Therapy in Treatment of Men With Premature Ejaculation and Erectile Dysfunction|
|Actual Study Start Date :||September 14, 2017|
|Estimated Primary Completion Date :||January 14, 2020|
|Estimated Study Completion Date :||February 14, 2020|
|Experimental: Dapoxetine/Tadalafil 30/20 mg film coated tablet||
Drug: Dapoxetine/Tadalafil 30/20 mg film coated tablet
During 4-weeks treatment period, patients will take one Dapoxetine/Tadalafil 30/20 mg film coated tablet 1-3 hours before sexual intercourse.
Study drug should not be used more than 1 tablet every 24 hours during the treatment.
Other Name: Tada Plus
- Evaluation of safety of study drug [ Time Frame: 4 weeks ]Number of Participants with Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
- Evaluation of change in Intra-vaginal Ejaculation Latency Time (IELT) compared to baseline [ Time Frame: 4 weeks ]Intra-vaginal ejaculation latency time difference of one minute or more will be considered as efficient.
- Evaluation of IIEF-15 (International Index of Erectile Function) score compared to baseline [ Time Frame: 4 weeks ]Increase in IIEF score will be considered as efficacy.
- Evaluation of premature ejaculation symptom scores compared to baseline [ Time Frame: 4 weeks ]Increase in IIEF scores will be considered as efficacy.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03177746
|Okmeydanı Training and Research Hospital Urology Dep.|