Effect of Tadalafil Once a Day in Men With Erectile Dysfunction

NCT ID: NCT00836693

Last Updated: 2011-01-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 217 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2010-01-31

Brief Summary

The primary aim of this study is to assess the efficacy and safety of tadalafil 5 mg administered once a day in patients with erectile dysfunction (ED) who are naïve to PDE5 (phosphodiesterase type 5) inhibitors. Patients may be dose reduced to 2.5mg based on tolerability.

Conditions

Erectile Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Tadalafil

Group Type: EXPERIMENTAL

tadalafil

Intervention Type: DRUG

5 milligrams (mg) administered orally once a day for 12 weeks

Placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

tablet administered orally once a day for 12 weeks.

Interventions

tadalafil

5 milligrams (mg) administered orally once a day for 12 weeks

Intervention Type: DRUG

placebo

tablet administered orally once a day for 12 weeks.

Intervention Type: DRUG

Other Intervention Names

Cialis; LY450190

Eligibility Criteria

Inclusion Criteria

• You are male and aged at least 18 years.
• Have a history of erectile dysfunction (ED)(defined as the consistent inability to achieve and/or maintain an erection sufficient to permit satisfactory sexual intercourse) of at least 3 months duration.
• Agree not to use any other treatment for ED, including herbal and over-the-counter (OTC) medications, during the study
• You agree to make at least four sexual intercourse attempts with the female sexual study partner during the 4-week run-in period without medication
• Your entry laboratory test results and medical tests meet study requirements
• You agree to use the study drug only as instructed by your study doctor and staff and to return any unused study drug and containers at the end of the study or as otherwise instructed by the study doctor.
• If currently using cholesterol lowering medications (for example: statins) or medications to lower blood pressure (example: angiotensin-converting enzyme (ACE) inhibitors or calcium channel blocker medications), you need to be on a stable dose and you and your study doctor do not expect any dose change during the study.

Exclusion Criteria

• You have received previous or current treatment with tadalafil or any other PDE5 inhibitor.
• Currently receives treatment with doxazosin, nitrates, cancer chemotherapy, or anti-androgens (except finasteride e.g. Propecia™ or Proscar®, or dutasteride e.g. Avodart®).
• You have had significant heart disease as determined by your doctor in charge of this study or a member of the doctor's staff.
• Have a history of significant central nervous system injuries (including stroke or spinal cord injury) within the last 6 months.
• Have a history of loss of vision in one eye because of nonarteritic anterior ischemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Eli Lilly

Principal Investigators

Call 1-877-CTLILLY(1-877-285-459) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM eastern time (UTC/GMT -5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Bad Wiessee, , Germany

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Berlin, , Germany

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Hamburg, , Germany

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Koblenz, , Germany

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Leipzig, , Germany

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Athens, , Greece

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Pátrai, , Greece

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Thessaloniki, , Greece

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Catania, , Italy

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Florence, , Italy

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L’Aquila, , Italy

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Milan, , Italy

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Rome, , Italy

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Bialystok, , Poland

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Legionowo, , Poland

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Lodz, , Poland

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Warsaw, , Poland

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Aravaca, , Spain

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Barcelona, , Spain

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Madrid, , Spain

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Majadahonda, , Spain

Countries

Germany; Greece; Italy; Poland; Spain

References

Porst H, Gacci M, Buttner H, Henneges C, Boess F. Tadalafil once daily in men with erectile dysfunction: an integrated analysis of data obtained from 1913 patients from six randomized, double-blind, placebo-controlled, clinical studies. Eur Urol. 2014 Feb;65(2):455-64. doi: 10.1016/j.eururo.2013.09.037. Epub 2013 Oct 2.

Reference Type: DERIVED

PMID: 24119319 (View on PubMed)

Porst H, Brock GB, Kula K, Moncada I, Montorsi F, Basson BR, Kinchen K, Aversa A. Effects of once-daily tadalafil on treatment satisfaction, psychosocial outcomes, spontaneous erections, and measures of endothelial function in men with erectile dysfunction but naive to phosphodiesterase type 5 inhibitors. J Androl. 2012 Nov-Dec;33(6):1305-22. doi: 10.2164/jandrol.111.015289. Epub 2012 Jul 12.

Reference Type: DERIVED

PMID: 22790642 (View on PubMed)

Montorsi F, Aversa A, Moncada I, Perimenis P, Porst H, Barker C, Shane MA, Sorsaburu S. A randomized, double-blind, placebo-controlled, parallel study to assess the efficacy and safety of once-a-day tadalafil in men with erectile dysfunction who are naive to PDE5 inhibitors. J Sex Med. 2011 Sep;8(9):2617-24. doi: 10.1111/j.1743-6109.2011.02353.x. Epub 2011 Jun 27.

Reference Type: DERIVED

PMID: 21707928 (View on PubMed)

Other Identifiers

H6D-MC-LVHX

Identifier Type: OTHER

Identifier Source: secondary_id

12229

Identifier Type: -

Identifier Source: org_study_id