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tadalafil once a day

Phase 3

Erectile Dysfunction | Small molecule | Endocrine |Eli Lilly and Company|Trials Updated: Nov 18, 2010

tadalafil once a day target and mechanism

Molecular targetPDE5A
Target classInhibitor
ModalitySmall molecule
ChEMBLCHEMBL779

Also known as tadalafil once a day [T(OaD)]

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment378

FDA Designations

No designations recorded

tadalafil once a day clinical trials

tadalafil once a day · 1 trial · 1 indication

Phase 3 1
NCT00734604A Study for Patients With Erectile Dysfunction to Test Whether Tadalafil Taken Once a Day Can Better Improve Psychological Outcomes.Erectile Dysfunction
COMPLETED378 Analytics
PHASE3COMPLETED
A Study for Patients With Erectile Dysfunction to Test Whether Tadalafil Taken Once a Day Can Better Improve Psychological Outcomes.
Erectile DysfunctionUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline Between Tadalafil Once a Day (OaD) and Sildenafil as Needed (PRN) in Sexual Self-Confidence Domain of Psychological and Interpersonal Relationship Scales (PAIRS)
baseline, 8 weeks of each treatment

The PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Sexual Self-Confidence score is the average of responses on 6 PAIRS item scores. Sexual Self-Confidence scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater sexual self-confidence.

Secondary Endpoints

Change From Baseline Between Tadalafil Once a Day (OaD) and Tadalafil as Needed (PRN) in Sexual Self-Confidence Domain of Psychological and Interpersonal Relationship Scales (PAIRS)
baseline, 8 weeks of each treatment
Change From Baseline to Endpoint in the Spontaneity Domain of PAIRS
baseline, 8 weeks of each treatment
Change From Baseline to Endpoint in the Time Concerns Domain of PAIRS
baseline, 8 weeks of each treatment
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
T(OaD)/S(PRN)/T(PRN)EXPERIMENTALTadalafil 5 mg once a day \[T(OaD)\] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed \[S(PRN)\] for 8 weeks, 1 week washout, tadalafil 20 mg as needed \[T(PRN)\] for 8 weeks
T(OaD)/T(PRN)/S(PRN)EXPERIMENTALTadalafil 5 mg once a day \[T(OaD)\] for 8 weeks, 1 week washout, tadalafil 20 mg as needed \[T(PRN)\] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed \[S(PRN)\] for 8 weeks
S(PRN)/T(OaD)/T(PRN)EXPERIMENTALSildenafil citrate 100 mg as needed \[S(PRN)\] for 8 weeks, 1 week washout, tadalafil 5 mg once a day \[T(OaD)\] for 8 weeks, 1 week washout, tadalafil 20 mg as needed \[T(PRN)\] for 8 weeks
S(PRN)/T(PRN)/T(OaD)EXPERIMENTALSildenafil citrate 100 mg as needed \[S(PRN)\] for 8 weeks, 1 week washout, tadalafil 20 mg as needed \[T(PRN)\] for 8 weeks, 1 week washout, tadalafil 5 mg once a day \[T(OaD)\] for 8 weeks
T(PRN)/T(OaD)/S(PRN)EXPERIMENTALTadalafil 20 mg as needed \[T(PRN)\] for 8 weeks, 1 week washout, tadalafil 5 mg once a day \[T(OaD)\] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed \[S(PRN)\] for 8 weeks
T(PRN)/S(PRN)/T(OaD)EXPERIMENTALTadalafil 20 mg as needed \[T(PRN)\] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed \[S(PRN)\] for 8 weeks, 1 week washout, tadalafil 5 mg once a day \[T(OaD)\] for 8 weeks

Interventions

NameTypeDescription
tadalafil once a day [T(OaD)]DRUG5 mg tablet taken once a day (OaD) by mouth for 8 weeks
sildenafil citrate as needed [S(PRN)]DRUG100 mg tablet taken as needed (PRN) by mouth for 8 weeks
tadalafil as needed [T(PRN)]DRUG20 mg tablet taken as needed (PRN) by mouth for 8 weeks
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Eligibility Criteria

Age Range18 Years to N/A
SexMALE
Healthy VolunteersNo
Study Sites37

Inclusion Criteria: * History of erectile dysfunction (ED). * Have had satisfactory response to tadalafil, sildenafil citrate, or vardenafil HCl for a period of at least 6 months and expect frequent use (at least one dose per week, on average) when administered as needed. * Have never used tadalafi...

Countries:United StatesAustraliaBrazilGermanyItalyMexicoPuerto RicoSpainUnited Kingdom
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Frequently asked questions about tadalafil once a day

What is tadalafil once a day?

Tadalafil once a day is an oral small molecule therapy being studied for erectile dysfunction. It is a once-daily dosing regimen of tadalafil, developed by Eli Lilly and Company under the ticker LLY. The regimen is intended to provide continuous treatment rather than on-demand dosing for men with erectile dysfunction.

What is tadalafil once a day used for?

Tadalafil once a day is used for the treatment of erectile dysfunction in adult men. It is a once-daily oral regimen studied in a Phase 3 trial that enrolled 378 men aged 18 years and older. The trial evaluated whether daily dosing could improve psychological outcomes in patients with erectile dysfunction.

What does tadalafil once a day target?

Tadalafil once a day targets PDE5A, also known as phosphodiesterase type 5. It acts as an inhibitor of this enzyme. By inhibiting PDE5A, the drug affects the cyclic GMP pathway involved in penile smooth muscle relaxation and erectile function. This mechanism underlies its use in erectile dysfunction.

Who makes tadalafil once a day?

Tadalafil once a day is developed by Eli Lilly and Company, which trades under the ticker LLY. Lilly is the sponsor of the clinical program evaluating this once-daily tadalafil regimen for erectile dysfunction.

What phase is tadalafil once a day in?

Tadalafil once a day is in Phase 3 development. It is investigational and has not been approved by the FDA for this once-daily erectile dysfunction indication. The Phase 3 program includes one completed trial, and no active trials are currently listed for this regimen.

What clinical trials is tadalafil once a day in?

Tadalafil once a day has been studied in the Phase 3 trial NCT00734604, titled A Study for Patients With Erectile Dysfunction to Test Whether Tadalafil Taken Once a Day Can Better Improve Psychological Outcomes. The trial is completed, enrolled 378 male participants aged 18 years and older, and was conducted across the United States, Australia, Brazil, Germany, Italy, Mexico, Puerto Rico, Spain, and the United Kingdom.

Is tadalafil once a day the same as tadalafil once a day [T(OaD)]?

Yes, tadalafil once a day [T(OaD)] is another name for tadalafil once a day. Both refer to the same once-daily oral tadalafil regimen developed by Eli Lilly and Company for erectile dysfunction. The abbreviation T(OaD) stands for tadalafil once a day.