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NCT00741468 · ClinicalTrials.gov registry record · Phase 1

Open-Label, Multiple-Dose, Non-Randomized Study to Assess Drug-Drug Interactions of Proellex® in Female Subjects

A Phase 1 study of Drug Interactions, sponsored by Repros Therapeutics.

Completed
Registry status
Phase 1
Development phase
18
Enrollment target
1
Study location

NCT00741468 is a Phase 1 study of Drug Interactions that has completed, run by Repros Therapeutics. The registered enrollment target is 18 participants, below the 727-participant average among 6 other Drug Interactions trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00741468, a Phase 1 study of Drug Interactions, has completed, sponsored by Repros Therapeutics.

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

Study Summary

This study will assess possible drug-drug interactions with specific isoenzymes over a total study duration of 6-8 weeks. Blood samples collected pre and post-dose, and urine samples collected post dose will be analyzed.

Conditions Studied

Interventions

  • DRUG Proellex
  • DRUG CYP1A2 probe
  • DRUG CYP2C9 probe
  • DRUG CYP2C19 probe
  • DRUG CYP2D6 probe

Study Locations (1)

New Jersey

  • Clinical Research Center Advanced Biomedical Research Inc. - Hackensack

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2008-07
Est. Completion 2008-10
Phase Phase 1

Sponsor

Repros Therapeutics

50 total trials

What the Registry Record Tells You About NCT00741468

The ClinicalTrials.gov registry entry for NCT00741468 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 727-participant average among 6 other Drug Interactions trials with a reported enrollment target (98% lower). The listed sponsor is Repros Therapeutics, which has 50 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Drug Interactions appearing as the primary indexed condition, and to 5 interventions - of which Proellex is the first listed.

NCT00741468 reports 1 study location spanning 1 distinct geographic area - top geographies include New Jersey.

Frequently Asked Questions

What is clinical trial NCT00741468 about?

NCT00741468 is a clinical study titled "Open-Label, Multiple-Dose, Non-Randomized Study to Assess Drug-Drug Interactions of Proellex® in Female Subjects". This study will assess possible drug-drug interactions with specific isoenzymes over a total study duration of 6-8 weeks. Blood samples collected pre and post-dose, and urine samples collected post dose will be analyzed.

What is the current status of trial NCT00741468?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2008-07. Estimated completion is 2008-10.

What conditions does trial NCT00741468 study?

This clinical trial studies the following conditions: Drug Interactions.

What interventions are being tested in trial NCT00741468?

The interventions under investigation include: Proellex (DRUG), CYP1A2 probe (DRUG), CYP2C9 probe (DRUG), CYP2C19 probe (DRUG), CYP2D6 probe (DRUG).

Who is sponsoring clinical trial NCT00741468?

This trial is sponsored by Repros Therapeutics, which has 50 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00741468 being conducted?

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

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.