This website is maintained by Lilly ICOS LLC, a joint venture between Eli Lilly and Company and ICOS Corporation. It contains publicly disclosed information about the results of confirmatory (hypothesis-testing) clinical trials conducted after October 15, 2002 to test the safety and efficacy of tadalafil, a prescription drug that is marketed under the brand name Cialis®. Only clinical trials that have been completed and published in peer-reviewed journals are included here. For information about ongoing clinical trials involving tadalafil, please see www.clinicaltrials.gov.

Lilly ICOS LLC is the sponsor of all studies listed here.



Drug Name: Generic Name: Title of Study: Dates of Trial:
1. Cialis tadalafil A Randomized, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate The Efficacy And Safety of IC351 (5 mg And 10 mg) Administered Once Daily To Men With Erectile Dysfunction
September 17, 2001 -
October 16, 2003
2. Cialis tadalafil A Randomized, Double-Blind, Parallel, Placebo-Controlled Study To Evaluate The Efficacy And Safety of IC351 Administered “On Demand” To Men With Erectile Dysfunction
February 12, 2002 -
December 6, 2002
3. Cialis tadalafil Multinational Evaluation of the Efficacy, Safety and Treatment Satisfaction of Tadalafil administered “On Demand” to Men with Erectile Dysfunction
August 14, 2002 -
July 21, 2003
4. Cialis tadalafil A Randomized, Double-Blind, Parallel, Placebo-Controlled Study To Evaluate The Efficacy And Safety of IC351 Administered “On Demand” To Men With Erectile Dysfunction
October 7, 2002 -
May 6, 2003
5. Cialis tadalafil A Randomized, Double-blind, Parallel, Placebo-Controlled Study To Evaluate the Efficacy And Safety of IC351 (Tadalafil) Administered “On Demand” to Men with Erectile Dysfunction
October 21, 2002 -
July 23, 2003
6. Cialis tadalafil A Multicenter Open-Label Study to Determine Treatment Preference of Tadalfil (IC351, LY450190) or Sildenafil Citrate in the Oral Treatment of Erectile Dysfunction
October 31, 2003 -
November 22, 2004
7. Cialis tadalafil A Randomized, Crossover, Open-Label Study of IC351 (LY450190) Administered to Patients with Erectile Dysfunction Assessing Patient Preference for Either an "On-Demand" or a "Scheduled" Treatment Regimen
October 14, 2002 -
July 2, 2003
8. Cialis tadalafil A Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tadalfil Administered "On-Demand" to Asian Men with Erectile Dysfunction
May 8, 2003 -
December 23, 2003
9. Cialis tadalafil An Open-Label Study to Evaluate the Efficacy and Safety of Tadalfil Administered "On Demand" to Men of Various Populations with Erectile Dysfunction
August 22, 2003 -
March 12, 2004


Cialis has been approved for marketing in the United States and many other countries worldwide for treatment of erectile dysfunction. This information is posted pursuant to the requirements of 22 Maine Revised Statutes § 2700-A; it is not intended to promote or otherwise commercialize (directly or indirectly) any off-label or unapproved use of Lilly ICOS products. Prescribing decisions should be made based on the applicable approved package insert. Prescribing information approved in the United States is available at www.fda.gov; healthcare professionals in other countries should consult the prescribing information approved in their country.

Nothing on this website should be construed as giving advice or making a recommendation. This information is not intended to replace the advice of a health care professional; only a physician can determine if a specific treatment is suitable for a particular patient.