NCT01415128 is a Phase 1 clinical trial of Omeprazole in Erectile Dysfunction, sponsored by VIVUS LLC.

Who is sponsoring NCT01415128?

NCT01415128 is sponsored by VIVUS LLC.

What drugs are being tested in NCT01415128?

Interventions in NCT01415128: Omeprazole, Rosiglitazone, Desipramine.

What condition does NCT01415128 study?

NCT01415128 studies Erectile Dysfunction.

Is NCT01415128 still recruiting?

NCT01415128 is currently completed. Last updated 10 August 2011.

Last reviewed 2011-08-10 · How we verify

NCT01415128

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

A PHASE I, SINGLE-CENTER, OPEN-LABEL, CROSSOVER STUDY OF THE EFFECT OF AVANAFIL ON THE PHARMACOKINETICS OF OMEPRAZOLE, DESIPRAMINE AND ROSIGLITAZONE IN HEALTHY MALE SUBJECTS

Completed Phase 1 Last updated 10 August 2011

What this trial tests

Phase 1 trial testing Omeprazole in Erectile Dysfunction in 60 participants. Completed in 1 May 2010.

Timeline

1 April 2010

Primary endpoint
1 May 2010

1 May 2010

Quick facts

Lead sponsor	VIVUS LLC
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	1 April 2010
Primary completion	1 May 2010
Estimated completion	1 May 2010

Drugs / interventions tested

Omeprazole (omeprazole) — full drug profile →
Rosiglitazone (ROSIGLITAZONE) — full drug profile →
Desipramine (DESIPRAMINE) — full drug profile →

Conditions studied

Erectile Dysfunction — all drugs for Erectile Dysfunction →

Sponsor

VIVUS LLC — full company profile →

Who can join

Adults 18 to 45, male only, with Erectile Dysfunction. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

To measure a composite of pharmacokinetic parameters of Omeprazole, Rosiglitazone and Desipramine.
Time frame: 0, 20, 40 minutes and 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10 and 12 hours post dose
AUC0-t, AUC0-inf, Cmax, tmax, half-life

Sponsor's own description

This study will compare the pharmacokinetics of omeprazole, rosiglitazone and desipramine when administered with a single oral dose of avanafil in healthy male subjects.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Omeprazole

Trials testing the same drug.

NCT07214662 — A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-0587 as a Monotherapy and in Combination With Gire · Phase 1 · recruiting
NCT07223671 — Study to Evaluate the Effect of Repotrectinib on the Drug Levels of Transporter and CYP P450 Probe Substrates in Healthy · Phase 1 · completed
NCT07235748 — Drug-drug Interaction Study of Vorasidenib With Bupropion, Repaglinide, Flurbiprofen, Omeprazole, Midazolam, and Rosuvas · Phase 1 · completed
NCT07149415 — A Study to Learn if Taking BIIB141 (Omaveloxolone) Affects How Omeprazole is Processed in the Body and About BIIB141's S · Phase 1 · completed
NCT06948006 — A Study to Investigate the Relative Bioavailability of 2 Different Formulations of AZD4144, the Effect of Food and Omepr · Phase 1 · completed

Other recruiting trials for Erectile Dysfunction

Currently open trials in the same condition.

NCT07442396 — The Effectiveness of Exercise in the Treatment of Erectile Dysfunction and Premature Ejaculation · NA · recruiting
NCT07366970 — Is There a Benefit From Addition of Exercise in Diabetic Patients With ED Who Complain Low Vitamin D? · NA · recruiting
NCT06960746 — Changing Lifestyle in OSA Males Who Suffer Metabolic Syndrome and Impotence: Is There a Response? · NA · recruiting
NCT06872866 — The Objective of This Phase 1 Study is to Evaluate the Food Effect of 100 mg Hezkue Turbo® (ASP-001.1, Sildenafil) Under · Phase 1 · recruiting
NCT06805513 — Actual Use Trial of Tadalafil 5 mg · Phase 3 · recruiting

Other VIVUS LLC trials

Trials by the same sponsor.

NCT06915246 — A Study of Carmustine With and Without Ethanol in Subjects With Lymphoma · Phase 2 · recruiting
NCT05215418 — A Study of VI-0521 on Ambulatory Blood Pressure (ABPM) in Overweight or Obese Subjects · Phase 4 · completed
NCT03922945 — A Phase IV Safety and Efficacy Study of VI-0521 in Adolescents With Obesity · Phase 4 · completed

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 NCT01415128 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by VIVUS LLC
Last refreshed: 10 August 2011

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/NCT01415128.

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