Last updated: 11/04/2018 10:08:26
A Study On Concentrations Of 16448 In Blood And The Safety Of This Compound In Healthy Males With Premature Ejaculation
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A randomized, double-blind, placebo-controlled, two-session study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of an 16448 in healthy males with premature ejaculation.
Trial description: 16448 is being investigated for the treatment of primary premature ejaculation (PE) using a novel mode of action. There are no approved therapies for premature ejaculation, and novel therapies are needed for this syndrome. 16448 has been shown to increase ejaculatory latency in the PCA rat model of premature ejaculation.A novel instrument, the Sexual Assessment Monitor (SAM), will be used to measure ejaculatory latency time in this study. This device, which measures ELT under standard conditions, has been shown to provide a more reliable measure of ejaculatory latency compared to the use of a stopwatch during sexual intercourse
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
-vital signs, ECGs, clinical laboratory tests, adverse events at 24h -area under plasma drug concentration versus time curve [AUC (0-t),AUC (0-8)], maximum observed plasma concentration (Cmax),time at max concentration(Tmax)& half life (T1/2)
Timeframe: 24h
Secondary outcomes:
Measurement of ELT following a single dose of 16448 compared to placebo at approximately 1-2h, post-dose
Timeframe: 1-2h, post-dose
Interventions:
Drug: 16448
Enrollment:
18
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Premature Ejaculation
Product
retosiban
Collaborators
Not applicable
Study date(s)
December 2006 to June 2007
Type
Interventional
Phase
2
Participation criteria
Sex
Male
Age
18 - 45 years
Accepts healthy volunteers
No
- Body weight >50kg
- Body Mass Index (BMI): 19-30
- Previous or current use of any PDE-5(Phosphodiesterase type 5) inhibitors for the treatment of Erectile Dysfunction
- Subject receiving treatment in the last 6 months for depression, psychiatric disorders, mood disorders, schizophrenia, substance abuse or anxiety disorders
Inclusion and exclusion criteria
Inclusion criteria:
- Body weight >50kg
- Body Mass Index (BMI): 19-30
- Healthy men with long term (at least 6 months) symptoms of PE
- Erectile Dysfunction – (patients should have EF(Erectile Function) domain of IIEF(International Index of Erectile Function questionnaire >26 or normal)
- No history of reduced sexual desire
- No history of significant psychiatric illness or currently active significant medical illness
- No SSRI’s(Selective Serotonin Reuptake Inhibitors) use within the last 4 months
- No history of diabetes, renal or hepatic disease
- No significant injuries to the head or spinal cord i.e. history of head injury, spinal cord injuries, and conditions such as multiple sclerosis.
Exclusion criteria:
- Previous or current use of any PDE-5(Phosphodiesterase type 5) inhibitors for the treatment of Erectile Dysfunction
- Subject receiving treatment in the last 6 months for depression, psychiatric disorders, mood disorders, schizophrenia, substance abuse or anxiety disorders
- Subject is taking tricyclic anti-depressants, selective serotonin reuptake inhibitors (or related drugs), mono-amine oxidase inhibitors or ß-blockers
- Subject has received or is continuing to receive any treatment for PE (e.g. local anaesthetic spray, or intra-cavernosal injection) in the four weeks prior to the study start
- Subject has a history of other clinically significant organic diseases e.g. uncontrolled hypertension, ischemic heart
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2007-06-06
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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