Investigation of the Changes of Brain Structure and Function in Premature Ejaculation Patients and the Effects of Dapoxetine on Central Neural Activity in Premature Ejaculation Patients
|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: NCT03583112|
Recruitment Status : Recruiting
First Posted : July 11, 2018
Last Update Posted : August 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Premature Ejaculation||Drug: Dapoxetine Hydrochloride Tablet Drug: Placebo Tablet||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Investigation of the Changes of Brain Structure and Function in Premature Ejaculation Patients and the Effects of Dapoxetine on Central Neural Activity in Premature Ejaculation Patients|
|Actual Study Start Date :||July 10, 2018|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Active Comparator: Dapoxetine
In this group, patients received one dapoxetine hydrochloride tablet before MRI scan.
Drug: Dapoxetine Hydrochloride Tablet
oral one dapoxetine hydrochloride tablet before MRI scan
Placebo Comparator: Placebo
In this group, patients received placebo tablet before MRI scan.
Drug: Placebo Tablet
oral one placebo tablet before MRI scan.
- Resting-state brain function measured by Functional magnetic resonance imaging [ Time Frame: One day ]We will use several indicators to assess the resting-state brain function based on fMRI analysis, including regional homogeneity,Amplitude of Low Frequency Fluctuations, and functional connectivity.
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): NCT03583112
|Contact: xuejuan Yangfirstname.lastname@example.org|
|The ART Center, The Northwest Women's and Children's Hospital,||Recruiting|
|Xi'an, Shaanxi, China, 710003|
|Contact: Xuejuan Yang|
|Principal Investigator:||Gao||The ART Center, The Northwest Women's and Children's Hospital|