Health TrialsbyHealthPanel

Daily Tadalafil as Adjunctive Therapy Versus Monotherapy for PDE5 Inhibitor-Resistant Erectile Dysfunction

ConditionsErectile DysfunctionTadalafil
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexMale
Age18-70
SponsorAl-Azhar University

About this trial

This randomized trial will compare daily tadalafil 5 mg as adjunct therapy versus monotherapy in men with on-demand PDE5 inhibitor-resistant erectile dysfunction. The study will evaluate changes in erectile function, treatment satisfaction, partner satisfaction, and safety over 12 weeks.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: 18 to 70 years.

Diagnosis: Erectile dysfunction for at least 6 months.

International Index of Erectile Function-Erectile Function score less than 26 despite optimal dosing.

Self-reported inability to achieve or maintain an erection sufficient for satisfactory sexual intercourse in at least 50% of attempts.

Disqualifiers

Current use of nitrates.

Unstable cardiovascular disease, including recent myocardial infarction within 6 months, unstable angina, or severe heart failure.

Uncontrolled hypertension greater than 180 over 110 mmHg or severe hypotension less than 90 over 50 mmHg.

Severe hepatic impairment, Child-Pugh class C, or renal impairment with estimated glomerular filtration rate less than 30 mL per minute per 1.73 m².

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tadalafil; Current on-demand PDE5 inhibitor

    Drug

    Tadalafil 5 mg orally once daily for 12 weeks plus the participant's current effective on-demand PDE5 inhibitor, taken 1-2 hours before sexual activity, with a maximum of once daily.

  • Tadalafil 5 mg

    Drug

    Tadalafil 5 mg orally once daily for 12 weeks.

Treatment groups

260 Participants
are divided into 2 treatment groups
Group A: Adjunct TherapyExperimental treatment 2 interventions
Group B: MonotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

change in International Index of Erectile Function-Erectile Function score from baseline to week 12.

The International Index of Erectile Function-Erectile Function domain score ranges from 1 to 30, with higher scores indicating better erectile function.

Time frame
12 weeks
2

Adverse effect / side effect

a harmful effect that is attributable to the intervention.

Time frame
12 weeks

Secondary outcomes

1

Responder rate

proportion of participants achieving International Index of Erectile Function-Erectile Function score of at least 26 or an increase of at least 5 points from baseline. A score of 26 or higher is commonly used to indicate normal erectile function, and a 5-point increase is a clinically meaningful response threshold in erectile dysfunction studies

Time frame
12 weeks
2

Percentage of Sexual Attempts With Successful Intercourse - Sexual Encounter Profile Question 3

Participants will complete Sexual Encounter Profile Question 3 for each evaluable sexual attempt during the treatment period: "Did your erection last long enough for you to have successful intercourse?" The outcome will be calculated for each participant as: SEP Q3 success rate = number of sexual attempts with a "yes" response total number of evaluable sexual attempts × 100 SEP Q3 success rate= total number of evaluable sexual attempts number of sexual attempts with a "yes" response * 100 The treatment groups will be compared using the participant-level percentage of successful sexual attempts.

Time frame
12 weeks
3

Percentage of Sexual Attempts With Successful Vaginal Penetration - Sexual Encounter Profile Question 2

Participants will complete Sexual Encounter Profile Question 2 (SEP Q2) for each evaluable sexual attempt during the 12-week treatment period: "Were you able to insert your penis into your partner's vagina?" For each participant, the SEP Q2 success rate will be calculated as: SEP Q2 success rate = number of sexual attempts with a "yes" response total number of evaluable sexual attempts × 100 SEP Q2 success rate= total number of evaluable sexual attempts number of sexual attempts with a "yes" response * 100 The treatment groups will be compared according to the percentage of sexual attempts resulting in successful vaginal penetration.

Time frame
12 weeks
4

Erection Hardness Score

It is a patient-reported 4-point scale used to assess erection firmness, ranging from 0 to 4, with higher scores indicating firmer erections.

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Al-Azhar University

Lead sponsor

Source ClinicalTrials.gov
Apply now