Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202211709374727 Date of Approval: 29/11/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The combination of Tadalafil, silodosin, and paroxetine is effective in the treatment of premature ejaculation.
Official scientific title A Randomized, Double-Blind, Placebo Controlled Phase 2 Study to assess the safety and efficacy of a combination of Tadalafil, Silodosin and Paroxetine HCI CR use concurrently for Premature Ejaculation (PE)
Brief summary describing the background and objectives of the trial Premature Ejaculation affects 20-30% of all men. It is defined as persistent or recurrent pattern of ejaculation occurring during partnered sexual activity within approximately 1 minute following vaginal penetration and before the individual wishes it. Yet as distressing as this can be to couples there have not been any FDA approved drug for this condition. A few off-label products have been tried before now. the primary objective of the study is to evaluate if the combination of the 3 drugs improves IVLT in a clinically significant fashion compared to placebo. The secondary objective is to assess the extent of (Clinical Global Impression of Change) with the combination drugs compared to placebo.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 21/11/2022
Actual trial start date
Anticipated date of last follow up 30/12/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group treatment arm on-demand dosing of study medication twice a week, three days apart 4 weeks increase in intravaginal latency time (IVLT) 30
Control Group control arm placebo 4 weeks no change in intravaginal latency time (IVLT) 30 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) Ages 18-49 (include 18 and 49) years old male 2) Have sexual intercourse with female on a regular basis (at least twice a week) 3) Intra-vaginal Latency Time (IVLT) < 1 min consistently for at least one year 1) Use of Certain medications/agents (e.g., Nitrates, other antihypertensive, grapefruit juice) 2) Known hypersensitivity to study agents 3) Current or history of kidney disease. GFR< 50 4) Recent History of MI 5) History of Erectile dysfunction Adult: 19 Year-44 Year 18 Year(s) 49 Year(s) Male
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 28/09/2022 Federal Neuropsychiatric Hospital Yaba human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
8 Harvey road Yaba yaba 101241 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome IELT at 3 weeks and 5 weeks compared with placebo 3 weeks and 5 weeks
Secondary Outcome Clinical Global Impression of Change 3 weeks and 5 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
federal neuropsychiatric hospital Yaba 8 Harvey road yaba Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
zyvran pharmaceuticals 355 S Grand ave. no 2450 los angeles 90071 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor zyvran pharmaceuticals 355 S Grand ave. no 2450 los angeles 90071 United States of America Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator olugbenga owoeye drowoeye@yahoo.com +2349030001907 8 harvey road
City Postal code Country Position/Affiliation
yaba Nigeria consultant psychiatrist
Role Name Email Phone Street address
Public Enquiries sterling mgbekwe sterling.mgbekwe@zyvranpharma.com +17144871901 355 S Grand ave. no 2450
City Postal code Country Position/Affiliation
los angeles 90071 United States of America clinical research associate
Role Name Email Phone Street address
Scientific Enquiries kristen Hu kristen.hu@zyvranpharma.com +12132336094 355 S Grand ave, no 2450
City Postal code Country Position/Affiliation
los angeles 90071 United States of America clinical research associate
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual deidentified participant data (including data dictionaries) will be shared. Individual participant data that underlie the results reported in the study after deidentification (tables, figures and appendices) will be shared. Additional related documents like study protocol and statistical analysis plan will be shared. Statistical Analysis Plan,Study Protocol Individual participant data and other related documents will be available for sharing beginning three months following study publication and ending 5 years after study publication. Researchers who wish to assess the data may request to have access to the data. Access to the data is controlled by the sponsor and can be requested by an email to the sponsor site pending review by the study team. The requestor should have an interest in clinical drug trials. The data could be used for any type of data analysis. The requestor will gain access to the data through a link to the sponsor’s site.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://www.zyvranpharma.com/ No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information