NCT05142254 (PIN) is a Phase 2 clinical trial of Tadalafil in Priapism Due to Sickle Cell Disease, sponsored by Vanderbilt University Medical Center.

Who is sponsoring NCT05142254?

NCT05142254 is sponsored by Vanderbilt University Medical Center.

What drugs are being tested in NCT05142254?

Interventions in NCT05142254: Tadalafil, Hydroxyurea, Placebo.

What condition does NCT05142254 study?

NCT05142254 studies Priapism Due to Sickle Cell Disease.

Is NCT05142254 still recruiting?

NCT05142254 is currently completed. Last updated 20 September 2024.

Last reviewed 2024-09-20 · How we verify

NCT05142254: PIN

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Trial for Prevention of Recurrent Ischemic Priapism in Men With Sickle Cell Disease: A Pilot Study

Completed Phase 2 Last updated 20 September 2024

What this trial tests

Phase 2 trial testing Tadalafil in Priapism Due to Sickle Cell Disease in 64 participants. Completed in 9 November 2023.

Timeline

1 April 2022

Primary endpoint
10 July 2023

9 November 2023

Quick facts

Lead sponsor	Vanderbilt University Medical Center
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	64
Start date	1 April 2022
Primary completion	10 July 2023
Estimated completion	9 November 2023
Sites	2 locations across Nigeria

Drugs / interventions tested

Tadalafil (tadalafil) — full drug profile →
Hydroxyurea — full drug profile →
Placebo

Conditions studied

Priapism Due to Sickle Cell Disease — all drugs for Priapism Due to Sickle Cell Disease →

Sponsor

Vanderbilt University Medical Center

Who can join

Adults 18 to 40, male only, with Priapism Due to Sickle Cell Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

Hydroxyurea (hydroxycarbamide) for sickle cell disease.
Rankine-Mullings AE, Nevitt SJ. · · 2022 · cited 42× · PMID 36047926 · DOI 10.1002/14651858.cd002202.pub3
Epidemiology and treatment of priapism in sickle cell disease.
Idris IM, Burnett AL, DeBaun MR. · · 2022 · cited 22× · PMID 36485155 · DOI 10.1182/hematology.2022000380
Go the Distance: Reproductive Health Care for People with Sickle Cell Disease.
Pecker LH, Kuo KHM. · · 2022 · cited 14× · PMID 36400542 · DOI 10.1016/j.hoc.2022.07.010
A controlled trial for preventing priapism in sickle cell anemia: hydroxyurea plus placebo vs hydroxyurea plus tadalafil.
Idris IM, Yusuf AA, Ismail II, Borodo AM, et al · · 2025 · cited 4× · PMID 40073378 · DOI 10.1182/blood.2024027898
Perspectives and challenges to discovering hemoglobin-inducing agents in Sickle Cell Disease.
Pavan AR, Lopes JR, Lima Imperador CH, Man Chin C, et al · · 2022 · cited 3× · PMID 36160143 · DOI 10.3389/fmed.2022.1002063
Annual Sickle Cell & Thalassaemia Conference (ASCAT) ‐ October 2024
· 2024

Verify or expand the search:

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Trials testing the same drug.

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Other Vanderbilt University Medical Center trials

Trials by the same sponsor.

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NCT07431541 — Topical Carboxytherapy Paste Following Microneedling · Phase 1, PHASE2 · not yet recruiting
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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05142254 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Vanderbilt University Medical Center
Last refreshed: 20 September 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05142254.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing