Tadalafil

Generic Name: Tadalafil

Brand Names: Adcirca, Alyq, Cialis, Entadfi, Tadliq, Talmanco (previously Tadalafil Generics), Tadalafil Mylan, Tadalafil Lilly, Adcirca (previously Tadalafil Lilly)

Drug Type: Small Molecule

Chemical Formula: C_₂₂H_₁₉N_₃O_₄

CAS Number: 171596-29-5

Unique Ingredient Identifier: 742SXX0ICT

Background: Tadalafil is a selective phosphodiesterase-5 inhibitor that is used in the treatment of erectile dysfunction (ED), pulmonary arterial hypertension (PAH), and benign prostatic hypertrophy. It was first approved in 2003 by the FDA for use in ED and later in 2009 for PAH. In contrast to other PDE5 inhibitors like sildenafil, tadalafil has greater selectivity for PDE5 and a longer half-life which has made it a more suitable option for chronic once-daily dosing in the treatment of PAH.

Indication: Tadalafil is indicated for the treatment of erectile dysfunction (ED) and either alone or in combination with finasteride for the treatment of benign prostatic hypertrophy (BPH). It is also indicated for the treatment of pulmonary arterial hypertension (PAH) both alone and in combination with macitentan or other endothelin-1 antagonists.

Associated Conditions: Benign Prostatic Hyperplasia (BPH), Erectile Dysfunction, Pulmonary Arterial Hypertension (PAH)

Associated Therapies: -

Clinical Trials

Tadalafil Taken Daily Compared to Placebo on Improvement of Getting and Maintaining an Erection and Sexual Quality of Life

Phase 3

Completed

Conditions: Impotence

Interventions: Drug: Placebo
Drug: tadalafil

First Posted Date: 2007-01-17

Last Posted Date: 2009-06-10

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 342

Registration Number: NCT00422734

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., La Joya, Mexico

Effect of Tadalafil on the Quality of Life and Sexual Life in Erectile Dysfunction

Phase 4

Completed

Conditions: Impotence
Erectile Dysfunction

First Posted Date: 2007-01-17

Last Posted Date: 2007-10-25

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 200

Registration Number: NCT00422578

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., Tampere, Finland

Efficacy and Safety of Tadalafil in Subjects With Erectile Dysfunction Caused by Spinal Cord Injury

Phase 3

Completed

Conditions: Erectile Dysfunction
Spinal Cord Injuries

First Posted Date: 2007-01-11

Last Posted Date: 2007-10-25

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 180

Registration Number: NCT00421083

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., Indianapolis, Indiana, United States

Effects of Tadalafil Once a Day for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia

Phase 2

Completed

Conditions: Benign Prostatic Hyperplasia

Interventions: Drug: Placebo
Drug: Tadalafil

First Posted Date: 2006-10-11

Last Posted Date: 2009-07-09

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 200

Registration Number: NCT00386009

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., Porto, Portugal

Study of Tadalafil Once-a Day for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia

Phase 2

Completed

Conditions: Benign Prostatic Hyperplasia

Interventions: Drug: placebo
Drug: tadalafil

First Posted Date: 2006-10-06

Last Posted Date: 2009-09-02

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 1058

Registration Number: NCT00384930

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., Greenwood, Indiana, United States

A Study of Semen Characteristics After 9 Months of Daily Tadalafil 20 mg

Phase 4

Completed

Conditions: Erectile Dysfunction

Interventions: Drug: placebo
Drug: tadalafil

First Posted Date: 2006-09-28

Last Posted Date: 2007-10-25

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 282

Registration Number: NCT00382135

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., Bothell, Washington, United States

A Study to Evaluate the Efficacy and Safety of 2.5mg and 5mg Tadalafil Given Once a Day to Men With Erectile Dysfunction

Phase 3

Completed

Conditions: Erectile Dysfunction

Interventions: Drug: placebo
Drug: tadalafil

First Posted Date: 2006-09-28

Last Posted Date: 2007-11-07

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 280

Registration Number: NCT00381732

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., Bothell, Washington, United States

Efficacy and Safety of Tadalafil in Hemodialysis Patients

Phase 2

Conditions: Erectile Dysfunction

First Posted Date: 2006-06-07

Last Posted Date: 2006-06-07

Lead Sponsor: University of Pernambuco

Target Recruit Count: 60

Registration Number: NCT00334477

Locations: 🇧🇷
Hospital de Aeronautica de Recife, Recife, Pernambuco, Brazil

A Study of Visual Effects of Erectile Dysfunction Medications Dosed Daily for Six Months

Phase 4

Completed

Conditions: Erectile Dysfunction

First Posted Date: 2006-06-02

Last Posted Date: 2007-10-25

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 198

Registration Number: NCT00333281

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., Indianapolis, Indiana, United States

Can Tadalafil Maintain Erectile Function In Patients Treated With Radiotherapy For Prostate Cancer?

Phase 3

Terminated

Conditions: Prostate Cancer
Erectile Dysfunction

First Posted Date: 2005-09-22

Last Posted Date: 2015-09-15

Lead Sponsor: Erasmus Medical Center

Target Recruit Count: 100

Registration Number: NCT00215631

Locations: 🇳🇱
Erasmus MC-Daniel den Hoed Cancer, Rotterdam, Netherlands

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