Clinical Trial Studying the Efficacy and Safety of IP2018 in Depressed, Erectile Dysfunction (ED) Patients

Phase 2

• Conditions: Erectile Dysfunction
• Interventions: Drug: IP2018; Drug: Placebo

• Registration Number: NCT04686916
• Lead Sponsor: Initiator Pharma

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 part in three treatment periods, in which they will be randomised to receive either a single dose of IP2018 or a single dose of placebo in each treatment period.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-09
• Study First Submitted QC: 2020-12-23
• Study First Posted: 2020-12-29
• Study Start: 2020-12-30
• Status Verified: 2022-08
• Last Update Submitted: 2023-02-28
• Last Update Posted: 2023-03-01
• Primary Completion: 2023-07-30
• Study Completion: 2023-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
IP2018_dose 1	IP2018	IP2018_dose1
Placebo	Placebo	Placebo
IP2018_dose 2	IP2018	IP2018_dose2

Primary Outcome Measures

Name	Time	Method
Erectile Function	A 6 hours time interval after dosing	Rigiscan device assessment of tumescence

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics of IP2018	From start to end of assessment	Tmax
Safety assessment	From randomisation to end of study participation	Clinical safety data from AE reporting, 12-lead electrocardiograms (ECGs), vital signs (standing and supine blood pressure, heart rate and oral temperature \[supine only\]), physical examinations and clinical laboratory evaluations

Trial Locations

Locations (1)

MAC; 🇬🇧 Manchester, United Kingdom