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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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25 November 2019 |
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Main ID: |
EUCTR2005-004648-30-GB |
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Date of registration:
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23/11/2005 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A randomized double blind, placebo controlled balanced 4-way crossover study to assess the efficacy of single oral doses of PF-00592379 on erectile function, using 100mg sildenafil as a positive control. - N/A
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Scientific title:
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A randomized double blind, placebo controlled balanced 4-way crossover study to assess the efficacy of single oral doses of PF-00592379 on erectile function, using 100mg sildenafil as a positive control. - N/A |
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Date of first enrolment:
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02/02/2006 |
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Target sample size:
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32 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-004648-30 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: yes
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: yes
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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United Kingdom
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Key inclusion & exclusion criteria
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Inclusion criteria:
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
1. Male subjects aged 18-65 years.
2. Subjects who have given written informed consent to participate in the study.
3. Subjects must be in a heterosexual stable relationship for at least the last six months.
4. Subjects must be willing to attempt sexual intercourse at least once per week on average.
5. Subjects with erectile dysfunction of no known organic cause of at least six months duration prior to entering the study (examples of organic causes include, but are not limited to, diabetes, hypertension, atherosclerosis, neuropathic disease). Erectile dysfunction is defined as “the inability to attain and/or maintain penile erection sufficient for satisfactory performance”. (Impotence – NIH Consensus Conference, JAMA, 1993, Vol 270:83-90).
6. Subjects with mild or moderate (11-25) erectile dysfunction as classified on the International Index of Erectile Function (IIEF).
7. Subjects must have previously responded to PDE5 inhibitors.
8. Subjects receiving treatment for MED such as PDE5 inhibitors, dopamine agonists, intracevernosal therapy or topical transurethral alprostadil or herbal therapies may be included provided they remain off therapy for two weeks prior to first dose and for the duration of the study.
9. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests and other trial procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
General criteria:
1. Subjects with any clinically significant abnormality following review of pre-study laboratory data and after a full physical examination.
2. Subjects with a history of significant cardiac disease particularly moderate or severe cardiac failure, unstable angina or recent myocardial infarction, stroke or life-threatening arrhythmia within the previous 6 months.
3. Subjects with a history of syncope or cardiac conduction abnormality (including paroxysmal brady or tachyarrhythmias).
4. Subjects who suffer from hypo- or hypertension (treated as well as untreated) or have a resting supine blood pressure below 90/50mmHg or above 170/110 or who show a postural drop in either systolic blood pressure of >20mmHg or diastolic blood pressure of >10mmHg at screening.
5. Subjects who are currently receiving vasoactive medication, such as, but not limited to, a-blockers, b-blockers, calcium antagonists.
6. Subjects with any clinically significant haematological, renal or hepatic abnormality.
7. Subjects with major psychiatric disorders and those who have received treatment for any major psychiatric disorder (eg. psychosis or hospitalization due to major depression) within the past 12 months.
8. Subjects who have received any experimental (i.e. non-approved) drug within the past four months (prior to the first dosing day of the study).
9. Subjects who drink more than 21 units of alcohol per week. (1 unit = 285ml of beer or 25 ml of spirits or 125ml of wine).
10. Subjects with a history of controlled substance abuse within the past 2 years.
11. Subjects who, in the opinion of the principal investigator, have any medical or psychological condition or social circumstances which would impair their ability to participate reliably in the study, or who may increase the risk to themselves or others by participating.
12. Subjects who in the opinion of the investigator are not likely to complete the study for whatever reason.
13. Subjects with a history of hypersensitivity to study drug and its excipients or known allergy to Sildenafil and/or dopamine agonists.
14. Subjects with other forms of sexual dysfunction (eg. retrograde ejaculation, anejaculation, painful ejaculation, premature ejaculation, hypoactive sexual desire and inhibited or absent orgasm).
Criteria specific to Sildenafil:
15. Subjects who are prescribed and/or taking medication which is contraindicated or cautioned with concomitant intake of PDE5 inhibitors, such as nitrates or nitric oxide donors in any form (oral, sublingual, buccal, inhalational or aerosols), cimetidine, CYP3A4 inhibitors, such as erythromycin, ketoconazole and protease inhibitors.
16. Subjects with retinitis pigmentosa.
17. Subjects with congestive cardiac failure or coronary artery disease causing unstable angina.
Criteria specific to dopamine agonists:
18. Subjects with cardiac arrythmias or severe cardiovascular disease.
Age minimum:
Age maximum:
Gender:
Female: no
Male: yes
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Health Condition(s) or Problem(s) studied
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Male Erectile Dysfunction (MED)
MedDRA version: 8.1
Level: LLT
Classification code 10052003
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Intervention(s)
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Product Name: PF-00592379
Product Code: PF-00592379
Pharmaceutical Form: Oral solution
Other descriptive name: 5-[(2R,5S)-5-methyl-4-propylmorpholin-2-yl]pyridin-2-amine di(1S)-10-camphorsulfonate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.01-
Pharmaceutical form of the placebo: Oral solution
Route of administration of the placebo: Oral use
Product Name: PF-00592379
Product Code: PF-00592379
Pharmaceutical Form: Oral solution
Other descriptive name: 5-[(2R,5S)-5-methyl-4-propylmorpholin-2-yl]pyridin-2-amine di(1S)-10-camphorsulfonate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.2-
Pharmaceutical form of the placebo: Oral solution
Route of administration of the placebo: Oral use
Product Name: PF-00592379
Product Code: PF-00592379
Pharmaceutical Form: Oral solution
Other descriptive name: 5-[(2R,5S)-5-methyl-4-propylmorpholin-2-yl]pyridin-2-amine di(1S)-10-camphorsulfonate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3-
Pharmaceutical form of the placebo: Oral solution
Route of administration of the placebo: Oral use
Product Name: PF-00592379
Product Code: PF-00592379
Pharmaceutical Form: Oral solution
Other descriptive name: 5-[(2R,5S)-5-methyl-4-propylmorpholin-2-yl]pyridin-2-amine di(1S)-10-camphorsulfonate
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 0.01-100
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Primary Outcome(s)
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Secondary Objective: To determine the safety and toleration of PF-00592379 in subjects with MED.
To determine the pharmacokinetic (PK) / pharmacodynamic (PD) relationship of PF-00592379.
To determine the efficacious dose range of PF-00592379.
To explore the efficacy of PF-00592379 in an outpatient setting.
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Main Objective: To assess the efficacy of single oral doses of PF-00592379 in improving penile erectile activity in subjects with MED.
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Primary end point(s): Total duration of erections = 60% rigidity at the base of the penis for the duration of the VSS.
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Secondary ID(s)
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N/A
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A7771002
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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