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NCT00619385 · ClinicalTrials.gov registry record · Phase 1

A Safety and Pharmacokinetic Study of Proellex®

A Phase 1 study, sponsored by Repros Therapeutics.

Completed
Registry status
Phase 1
Development phase
25
Enrollment target

NCT00619385: Completed Phase 1 study, sponsored by Repros Therapeutics.

NCT00619385 is a Phase 1 study that has completed, run by Repros Therapeutics. The registered enrollment target is 25 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00619385, a Phase 1 study, has completed, sponsored by Repros Therapeutics.

COMPLETED
Registry status
Phase 1
Development phase
25 participants
Enrollment target

Study Summary

Dose escalating study of 7 daily doses of Proellex at 100 mg, 150 mg and 200 mg

Primary Outcome

To determine the safety and PK properties of 100 mg, 150 mg and 200 mg of Proellex® taken for seven days by healthy adult female subjects.

Interventions

  • DRUG Proellex

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2008-02
Est. Completion 2008-10
Phase Phase 1
Repros Therapeutics

50 total trials

What the finished NCT00619385 record still lists

NCT00619385 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower).

The record links to 0 conditions, and to 1 intervention - of which Proellex is the first listed.

NCT00619385 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00619385 about?

NCT00619385 is a clinical study titled "A Safety and Pharmacokinetic Study of Proellex®". Dose escalating study of 7 daily doses of Proellex at 100 mg, 150 mg and 200 mg

What is the current status of trial NCT00619385?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2008-02. Estimated completion is 2008-10.

What interventions are being tested in trial NCT00619385?

The interventions under investigation include: Proellex (DRUG).

Who is sponsoring clinical trial NCT00619385?

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

How this trial's enrollment target compares

Where NCT00619385's enrollment target sits among peer trials

25 1495th of 2000 higher than 481 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 NCT00619385, the US trial registry maintained by the National Library of Medicine. NCT00619385 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.