Erectile Dysfunction
Conditions
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.
Interventions
DRUGIP2018
Test drug
DRUGPlacebo
Placebo
Sponsors
Initiator Pharma
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Erectile Function | A 6 hours time interval after dosing | Rigiscan device assessment of tumescence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Pharmacokinetics of IP2018 | From start to end of assessments | AUC |
Countries
United Kingdom
Contacts
Primary ContactClaus Olesen, PhD
Backup ContactMikael Thomsen, PhD
Outcome results
None listed