Status:
UNKNOWN
Clinical Trial Studying the Efficacy and Safety of IP2018 in Depressed, Erectile Dysfunction (ED) Patients
Lead Sponsor:
Initiator Pharma
Conditions:
Erectile Dysfunction
Eligibility:
MALE
18-55 years
Phase:
PHASE2
Brief Summary
This is a Phase IIa, randomised, double-blind, placebo-controlled, 3-period, crossover study to assess two single oral dose levels of IP2018. It is planned to enrol 24 patients. Patients will take par...
Eligibility Criteria
Inclusion
- \- Male patients with a diagnosis of mild to moderate depression and ED as determined from the Hamilton depression scale score of 7 to 23 and International Index of Erectile Function (IIEF-5) score of 12 to 18, respectively, with a body mass index of 18 to 32 kg/m2 (inclusive), of any ethnic origin.
Exclusion
- \- Any significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal (GI), haematological, endocrinological, metabolic, neurological, psychiatric conditions, or history of fainting or syncope or such condition that, in the opinion of Investigator, may place the patient at unacceptable risk as a participant in the study, may interfere with the interpretation of safety or tolerability data obtained in this study, or may interfere with the absorption, distribution, metabolism or excretion of drugs, or with the completion of treatment according to this protocol.
Key Trial Info
Start Date :
December 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2023
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04686916
Start Date
December 30 2020
End Date
August 30 2023
Last Update
March 1 2023
Active Locations (1)
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1
MAC
Manchester, United Kingdom