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NCT00914511 · ClinicalTrials.gov registry record · Phase 1

A Pharmacokinetic Study of Avanfil in Healthy Young Male Subjects

A Phase 1 study of Avanfil ADME and Semen Exposure, sponsored by VIVUS.

Completed
Registry status
Phase 1
Development phase
32
Enrollment target
1
Study location

NCT00914511: Completed Phase 1 study of Avanfil ADME and Semen Exposure, sponsored by VIVUS.

NCT00914511 is a Phase 1 study of Avanfil ADME and Semen Exposure that has completed, run by VIVUS. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00914511, a Phase 1 study of Avanfil ADME and Semen Exposure, has completed, sponsored by VIVUS.

COMPLETED
Registry status
Phase 1
Development phase
32 participants
Enrollment target
1
Study location

Study Summary

The purposes of this study are to: * Determine the effect of the study drug on sperm and semen of healthy young male subjects. * Determine the effect of age on the amount of study drug in the blood of healthy subjects * Learn about the safety of the study drug. * Learn how subjects tolerate the study drug.

Interventions

  • DRUG avanafil 200mg

Study Locations (1)

Arizona

  • MDS Pharma Services - Tempe

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2009-05
Est. Completion 2009-06
Phase Phase 1
VIVUS

35 total trials

What the finished NCT00914511 record still lists

NCT00914511 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).

The record links to 3 conditions, with Avanfil ADME appearing as the primary indexed condition, and to 1 intervention - of which avanafil 200mg is the first listed.

NCT00914511 reports a single indexed study location in Arizona.

Frequently Asked Questions

What is clinical trial NCT00914511 about?

NCT00914511 is a clinical study titled "A Pharmacokinetic Study of Avanfil in Healthy Young Male Subjects". The purposes of this study are to: * Determine the effect of the study drug on sperm and semen of healthy young male subjects. * Determine the effect of age on the amount of study drug in the blood of healthy subjects * Learn about the safety of the study drug. * Learn how subjects tolerate the stu...

What is the current status of trial NCT00914511?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2009-05. Estimated completion is 2009-06.

What conditions does trial NCT00914511 study?

This clinical trial studies the following conditions: Avanfil ADME, Semen Exposure, Sperm Function.

What interventions are being tested in trial NCT00914511?

The interventions under investigation include: avanafil 200mg (DRUG).

Who is sponsoring clinical trial NCT00914511?

This trial is sponsored by VIVUS, which has 35 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00914511 being conducted?

This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT00914511's enrollment target sits among peer trials

32 1296th of 2000 higher than 679 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00914511, the US trial registry maintained by the National Library of Medicine. NCT00914511 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.