CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 64 enrolled
Drug / intervention
Tadalafil +2 moredrug
Likely dose
Tadalafil 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05142254
NCT05142254Phase 2Completed
CompareCT.gov

A Randomized Controlled Double-Blind Trial for Prevention of Recurrent Ischemic Priapism in Men With Sickle Cell Disease: A Pilot Study

Vanderbilt University Medical Center·interventional·Posted Dec 2, 2021·Updated Sep 20, 2024

In Brief

A Phase 2 clinical trial evaluating Tadalafil, Hydroxyurea, and 1 other intervention for Priapism Due to Sickle Cell Disease. Completed, enrolled 64 participants across 2 sites.

Detailed Summary

To conduct a randomized controlled internal pilot feasibility trial for the prevention of recurrent ischemic priapism referred to as the Priapism in Nigeria (PIN) trial. The study team will enroll a minimum of 30 participants and a maximum of 200 participants. Study investigators hypothesize that hydroxyurea therapy combined with tadalafil is superior to a combination of hydroxyurea and placebo in the prevention of recurrent ischemic priapism.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPriapism Due to Sickle Cell Disease
CountriesNigeria
Collaborators--

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedDec 2, 2021
Enrollment StartApr 1, 2022
Primary CompletionJul 10, 2023
Study CompletionNov 9, 2023
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 4.6 years ago

Interventions

Tadalafildrug

2.5-5 mg/day

Hydroxyureadrug

20 mg/kg/day

Placebodrug

identical placebo to tadalafil created by Bond Biochemical, who is manufacturing the tadalafil as well.