Efficacy and Safety of the Coadministration of Tadarafil with Dutasteride in Men with Benign Prostatic Hyperplasia: A Phase III Randomized Open-Label Study

Efficacy and Safety of the Coadministration of Tadarafil with Dutasteride in Men with Benign Prostatic Hyperplasia: A Phase III Randomized Open-Label Study - CoaTAD study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000016796

Enrollment

560

Registered

2015-03-15

Start date

2015-05-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostatic Hyperplasia

Interventions

Dutasteride+Tadarafil Dutasteride alone

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Male aged 50 or higher with prostate volume of 30 ml or higher and IPSS of 8 or higher

Exclusion criteria

Exclusion criteria: 1) Prostate cancer 2) Nerogenic bladder 3) no administration of Dutasteride, Finasteride, anti-androgen, and testosterone within 6 months 4) no administration of drugs for overactive bladder and BPH exclude a1-blocker 5) no administration of PDE5 inhibitors 6) contraindication of Dutasteride 7) contraindication of Tadarafil

Design outcomes

Primary

Measure	Time frame
Total international prostate symptom score on 12 weeks after administration	—

Secondary

Measure	Time frame
Total IPSS on 24 weeks after administration IPSS sub-score, OABSS, IIEF, EHS, AMS Score, Uroflowmetry, Post-voided residual volume, adverse effect, BMI, blood pressure, waist size, prostate volume, Plaque score on 4, 12, and 24 weeks	—

Countries

Japan

Contacts

Public ContactYasuhide Kitagawa

Kanazawa University Graduate School of Medical Science Integrative Cancer Therapy and Urology

yasukita@med.kanazawa-u.ac.jp076-265-2393

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026