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

Erectile Dysfunction Clinical Trial

Official title:

A Randomised, Double-Blind, Placebo-Controlled, Crossover Trial Studying the Efficacy and Safety of IP2018 in Young, Depressed, Erectile Dysfunction (ED) Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04686916
• Other study ID #: IP2018CS01
• Status: Recruiting
• Phase: Phase 2
• Start date: December 30, 2020
• Est. completion date: August 30, 2023

Study information

• Verified date: August 2022
• Source: Initiator Pharma
• Contact: Claus Olesen, PhD
• Phone: 61260035
• Email: ceo[@]initiatorpharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: August 30, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Drug:
• IP2018
Test drug
• Placebo
Placebo

Locations

Country	Name	City	State
United Kingdom	MAC	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Initiator Pharma

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Erectile Function	Rigiscan device assessment of tumescence	A 6 hours time interval after dosing
Secondary	Safety assessment	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	From randomisation to end of study participation
Secondary	Pharmacokinetics of IP2018	AUC	From start to end of assessments
Secondary	Pharmacokinetics of IP2018	Tmax	From start to end of assessment