Concomitant Use of PriLigy in Men Treated for Erectile Dysfunction

NCT01063855 | Completed Phase 3 Results

• 3 other identifiers: CR016486R096769PRE30082009-013616-12
• Study Type: interventional
• Target: 495
• Locations: 13 countries
• Sites: 69

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of dapoxetine compared to placebo in men with premature ejaculation and erectile dysfunction who are currently being treated with a phosphodiesterase-5 inhibitor (ie, sildenafil, vardenafil, or tadalafil) for erectile dysfunction.

Conditions

Erectile Dysfunction; Sexual Dysfunction

Keywords

Erectile Dysfunction; Sexual Dysfunction; Dapoxetine hydrochloride; PRILIGY; Premature ejaculation; Serotonin Uptake Inhibitors; Sildenafil (Viagra); Vardenafil (Levitra); Tadalafil (Cialis)

Outcome Measures

Primary Outcomes (1)

• The Average Intravaginal Ejaculatory Latency Time (IELT) at Week 12

  The intravaginal ejaculatory latency time (IELT) is the time it takes for a man to ejaculate during sexual intercourse (as measured by stopwatch). The data below show the average IELT measured in minutes at Baseline (before treatment) to Endpoint (after 12 weeks of treatment). In this study, patients took placebo or dapoxetine along with a stable dose of a phosphodiesterase-5 inhibitor (PDE5I) prescribed prior to study entry for the treatment of erectile dysfunction.

  Baseline, Week 12

Secondary Outcomes (7)

• The Percentage of Patients Reporting At Least a 2-category Increase in Control Over Ejaculation

  At the end of treatment (Week 12)

• The Percentage of Patients Who Achieved 1-category or Greater Decrease (Improvement) in Personal Distress Related to Ejaculation

  At Endpoint (After 12 weeks of treatment)

• The Percentage of Patients Reporting a Composite Score of At Least a 2-category Increase in Control Over Ejaculation and At Least a 1-category Decrease in Personal Distress

  At the end of treatment (Week 12)

• The Percentage of Patients Who Achieved a 1-category or Greater Increase in Satisfaction With Sexual Intercourse

  Endpoint (After 12 weeks of treatment)

• The Percentage of Patients Reporting At Least a "Better" Response to Treatment

  Endpoint (After 12 weeks of treatment)

Study Arms (2)

Dapoxetine + PDE5I

EXPERIMENTAL

Dapoxetine 30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + a PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.

Drug: Dapoxetine; Drug: PDE5I (phosphodiesterase-5 inhibitor)

Placebo + PDE5I

PLACEBO COMPARATOR

Placebo tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + a PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.

Drug: Placebo; Drug: PDE5I (phosphodiesterase-5 inhibitor)

Interventions

Placebo DRUG

Tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks.

Placebo + PDE5I

Dapoxetine DRUG

30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks.

Dapoxetine + PDE5I

PDE5I (phosphodiesterase-5 inhibitor) DRUG

Patients were to be using a stable regimen of a PDE5-I (i.e., sildenafil, vardenafil, or tadalafil), as reported by the patient for the treatment of erectile dysfunction (ED) for at least 3 months before screening and up to 12 weeks during treatment in the study.

Dapoxetine + PDE5I; Placebo + PDE5I

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of erectile dysfunction (ED), International Index of Erectile Function (IIEF) score \>=21 at screening and baseline, and receiving treatment with a stable regimen of a phosphodiesterase 5 (PDE 5) inhibitor (ie, sildenafil, vardenafil, or tadalafil) for the treatment of ED for at least 3 months before screening
• Study participant in a stable, monogamous sexual relationship with the same woman for at least 6 months before screening and plan to maintain this relationship for the duration of the study
• Study participant medically stable (ie, in good general health) on the basis of physical examination, medical history, vital signs, 12 lead ECG, and clinical laboratory tests performed at screening

You may not qualify if:

• History suggestive of syncope (a condition characterized by a loss of consciousness)
• History of medical events such as surgical interventions or neurologic conditions (eg, multiple sclerosis), trauma, or infections that are associated with the development of symptoms of premature ejaculation (PE) and considered a potential cause of PE
• Current major psychiatric disorder such as mood disorder, anxiety disorder, schizophrenia, mania, suicidal ideation, other psychotic disorder, or alcoholism
• Known allergy, hypersensitivity, or intolerance to selective serotonin reuptake inhibitors (SSRIs) or selective noradrenaline reuptake inhibitors (SNRIs)
• Taken another investigational drug (or vaccine) within 30 days or used an investigational medical device within 6 months before screening, or enrolled in another investigational study

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Study Sites (69)

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Decatur, Alabama, United States

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Huntsville, Alabama, United States

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Englewood, Colorado, United States

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Aventura, Florida, United States

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Clearwater, Florida, United States

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Gainesville, Florida, United States

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West Palm Beach, Florida, United States

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Evansville, Indiana, United States

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Fort Wayne, Indiana, United States

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Baltimore, Maryland, United States

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Olive Branch, Mississippi, United States

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Kansas City, Missouri, United States

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Poughkeepsie, New York, United States

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Raleigh, North Carolina, United States

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Cleveland, Ohio, United States

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Portland, Oregon, United States

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Salem, Oregon, United States

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Ettrick, Virginia, United States

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Middleton, Wisconsin, United States

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Buenos Aires, Argentina

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Ciudad Autonoma de, Argentina

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Malvern, Australia

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Maroubra, Australia

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Perth, Australia

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St Leonards, Australia

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Brussels, Belgium

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Edegem, Belgium

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Liège, Belgium

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Coquitlam, British Columbia, Canada

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Guelph, Ontario, Canada

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Newmarket, Ontario, Canada

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Oakville, Ontario, Canada

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Sarnia, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Pointe-Claire, Quebec, Canada

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Garches, France

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Lille, France

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Lyon, France

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Marseille, France

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Nîmes, France

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Paris, France

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Toulouse, France

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Kuala Lumpur, Malaysia

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Kuching, Malaysia

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Petaling Jaya, Malaysia

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Cd. de Mexico, Mexico

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Culiacán, Mexico

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Durango, Mexico

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Monterrey, Mexico

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Katowice, Poland

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Lodz, Poland

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Lublin, Poland

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Szcezecin, Poland

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Wroclaw, Poland

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Moscow, Russia

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Saint Peterburg, Russia

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Saint Petersburg, Russia

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Chunjoo, South Korea

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Kwangjoo, South Korea

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Pusan, South Korea

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Seoul, South Korea

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Kaohsiung City, Taiwan

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Taoyuan District, Taiwan

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Chipping Norton, United Kingdom

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Leeds Yorkshire, United Kingdom

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Lichfield, United Kingdom

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Reading, United Kingdom

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South Brent, United Kingdom

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Related Publications (1)

• McMahon CG, Giuliano F, Dean J, Hellstrom WJ, Bull S, Tesfaye F, Sharma O, Rivas DA, Aquilina JW. Efficacy and safety of dapoxetine in men with premature ejaculation and concomitant erectile dysfunction treated with a phosphodiesterase type 5 inhibitor: randomized, placebo-controlled, phase III study. J Sex Med. 2013 Sep;10(9):2312-25. doi: 10.1111/jsm.12236. Epub 2013 Jul 11.

  PMID: 23845016 DERIVED

MeSH Terms

Conditions

Erectile Dysfunction; Sexual Dysfunction, Physiological; Premature Ejaculation

Interventions

dapoxetine; Phosphodiesterase 5 Inhibitors

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Ejaculatory Dysfunction

Intervention Hierarchy (Ancestors)

Phosphodiesterase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Results Point of Contact

• Title: CDTL, Cardiovascular and Metabolism
• Organization: Janssen Research & Development, LLC

1 908 704-4648

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2010
• First Posted: February 5, 2010
• Study Start: April 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: September 1, 2011
• Last Updated: January 24, 2013
• Results First Posted: November 5, 2012

Record last verified: 2013-01

Locations

CA (8); PL (5); FR (7); TW (2); US (19); AR (2); BE (3); AU (4); ME (4); RU (3); MY (3); KR (4); GB (5)