The Safety of Dapoxetine/Tadalafil Combination Therapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03177746|
Recruitment Status : Not yet recruiting
First Posted : June 6, 2017
Last Update Posted : May 17, 2022
|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|
|Estimated Study Start Date :||December 31, 2022|
|Estimated Primary Completion Date :||January 14, 2023|
|Estimated Study Completion Date :||October 14, 2023|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03177746
|Contact: Neutec R&D||00902128505102 ext 0000|
|Okmeydanı Training and Research Hospital Urology Dep.|
|Contact: Mehmet Gokhan Culha, Dr 00902123145555 ext 0000 firstname.lastname@example.org|