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 fo...

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

Endocrine Cardiomyopathy in Cushing Syndrome: Response to Cyclic GMP PDE5 inhibitOrs

Phase 2

Completed

Conditions: Cushing's Syndrome Cardiomyopathy

Interventions: Drug: Tadalafil

First Posted Date: 2015-11-20

Last Posted Date: 2023-05-16

Lead Sponsor: Andrea M. Isidori

Target Recruit Count: 18

Registration Number: NCT02611258

Locations: 🇮🇹
Elisa Giannetta, Rome, Italy

Endocrine Cardiomyopathy: Response to Cyclic GMP PDE5 Inhibitors in Acromegaly Cardiomyopathy

Phase 2

Completed

Conditions: Acromegaly Cardiomyopathy

Interventions: Drug: Tadalafil

First Posted Date: 2015-11-20

Last Posted Date: 2023-05-12

Lead Sponsor: Andrea M. Isidori

Target Recruit Count: 15

Registration Number: NCT02611336

Locations: 🇮🇹
Elisa Giannetta, Rome, Italy

Effects on Insulin Resistance With Tadalafil in Type 2 Diabetes - a Double-blind, Placebo-controlled Crossover Study

Phase 2

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Placebo
Drug: Tadalafil

First Posted Date: 2015-11-11

Last Posted Date: 2020-02-11

Lead Sponsor: Göteborg University

Target Recruit Count: 23

Registration Number: NCT02601989

Locations: 🇸🇪
Sahlgrenska University Hospital, Gothenburg, Sweden

Effect of Tadalafil on Insulin Secretion and Insulin Sensitivity in Obese Men.

Phase 4

Completed

Conditions: Obesity

Interventions: Drug: Placebo
Drug: Tadalafil

First Posted Date: 2015-11-03

Last Posted Date: 2020-10-09

Lead Sponsor: University of Guadalajara

Target Recruit Count: 18

Registration Number: NCT02595684

Locations: 🇲🇽
Instituto de Terapéutica Experimental y Clínica, Guadalajara, Jalisco, Mexico

The Efficacy and Safety of Initial Triple Versus Initial Dual Oral Combination Therapy in Patients With Newly Diagnosed Pulmonary Arterial Hypertension

Phase 3

Completed

Conditions: Pulmonary Arterial Hypertension

Interventions: Drug: Macitentan
Drug: Tadalafil
Drug: Selexipag

First Posted Date: 2015-09-23

Last Posted Date: 2021-04-13

Lead Sponsor: Actelion

Target Recruit Count: 247

Registration Number: NCT02558231

Locations: 🇺🇸
University of Texas Southwestern Medical Center, Dallas, Texas, United States
🇺🇸
Boston University Medical Center, Boston, Massachusetts, United States
🇺🇸
Tufts Medical Center, Boston, Massachusetts, United States

and more 55 locations

Daily Tadalafil on Body Fat and Lean Mass

Phase 4

Completed

Conditions: Obesity
Sexual Dysfunction

Interventions: Drug: Placebo
Drug: Tadalafil

First Posted Date: 2015-09-18

Last Posted Date: 2016-10-26

Lead Sponsor: University of Roma La Sapienza

Target Recruit Count: 20

Registration Number: NCT02554045

PDE5 Inhibition Via Tadalafil to Enhance Anti-Tumor Mucin 1 (MUC1) Vaccine Efficacy in Patients With HNSCC

Phase 1

Completed

Conditions: Head and Neck Squamous Cell Carcinoma
Head and Neck Cancer

Interventions: Other: Standard of Care Treatment
Drug: Tadalafil
Biological: Anti-MUC1 Vaccine
Other: Anti-MUC1 Vaccine Placebo
Biological: Anti-Influenza Vaccine
Other: Tadalafil Placebo
Other: Anti-Influenza Vaccine Placebo

First Posted Date: 2015-09-09

Last Posted Date: 2021-06-15

Lead Sponsor: Donald T. Weed, MD, FACS

Target Recruit Count: 16

Registration Number: NCT02544880

Locations: 🇺🇸
University of Miami, Miami, Florida, United States

Perfusion by Arterial Spin Labelling Following Single Dose Tadalafil in Small Vessel Disease (PASTIS) Trial

Phase 2

Completed

Conditions: Dementia, Vascular

Interventions: Drug: Placebo
Drug: Tadalafil
Behavioral: Cognitive functioning tests
Behavioral: Neuropsychological tests
Other: MRI Scan - Arterial Spin Labelling

First Posted Date: 2015-05-21

Last Posted Date: 2022-10-27

Lead Sponsor: St George's, University of London

Target Recruit Count: 55

Registration Number: NCT02450253

Locations: 🇬🇧
St George's Healthcare NHS Trust, London, United Kingdom

A Study of Tadalafil (LY450190) in Participants With Lower Urinary Tract Symptoms (LUTS) Suggestive of Benign Prostatic Hyperplasia LUTS (BPH-LUTS).

Phase 4

Completed

Conditions: Benign Prostatic Hyperplasia

Interventions: Drug: Placebo
Drug: Tadalafil
Drug: Alpha1 Blocker

First Posted Date: 2015-05-01

Last Posted Date: 2017-07-02

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 171

Registration Number: NCT02431754

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., Tokyo, Japan

A Study of LY2623091 in Healthy Participants

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: LY2623091
Drug: Tadalafil
Drug: Simvastatin
Drug: Itraconazole
Drug: Diltiazem

First Posted Date: 2014-11-24

Last Posted Date: 2020-06-26

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 48

Registration Number: NCT02300259

Locations: 🇺🇸
Covance Clinical Research Inc, Daytona Beach, Florida, United States

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