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NCT00695110 · ClinicalTrials.gov registry record · Phase 2

Pharmacokinetic Study of Oral Testosterone (T) Ester Formulations in Hypogonadal Men

A Phase 2 study, sponsored by Clarus Therapeutics.

Completed
Registry status
Phase 2
Development phase
29
Enrollment target

NCT00695110: Completed Phase 2 study, sponsored by Clarus Therapeutics.

NCT00695110 is a Phase 2 study that has completed, run by Clarus Therapeutics. The registered enrollment target is 29 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00695110, a Phase 2 study, has completed, sponsored by Clarus Therapeutics.

COMPLETED
Registry status
Phase 2
Development phase
29 participants
Enrollment target

Study Summary

The purpose of this pharmacokinetic study is to determine whether oral testosterone (T) ester formulations can be used effectively to treat men with low testosterone.

Primary Outcome

Sampling to determine serum T Cavg post AM and PM doses and for 24 hours in Treatment Periods 1, 2, and 4. Sampling to determine serum T Cavg post AM dose with food (Day 7) and fasting (Day 8) in Treatment Period 3.

Interventions

  • DRUG Oral testosterone undecanoate (TU) (300 mg T equivalents/dose)
  • DRUG Oral testosterone undecanoate (TU) combined with testosterone enanthate (TE) (400 mg T equivalents/dose)
  • DRUG Oral testosterone undecanoate (TU) (200 mg T equivalents/dose with and without food)
  • DRUG Oral testosterone undecanoate (TU) combined with testosterone enanthate (TE) (300 mg T equivalents/dose)

Trial Details

FieldValue
Enrollment Target 29 participants
Start Date 2008-06
Est. Completion 2009-08
Phase Phase 2
Clarus Therapeutics

11 total trials

What the finished NCT00695110 record still lists

NCT00695110 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% lower).

The record links to 0 conditions, and to 4 interventions - of which Oral testosterone undecanoate (TU) (300 mg T equivalents/dose) is the first listed.

NCT00695110 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00695110 about?

NCT00695110 is a clinical study titled "Pharmacokinetic Study of Oral Testosterone (T) Ester Formulations in Hypogonadal Men". The purpose of this pharmacokinetic study is to determine whether oral testosterone (T) ester formulations can be used effectively to treat men with low testosterone.

What is the current status of trial NCT00695110?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 29 participants. The study started on 2008-06. Estimated completion is 2009-08.

What interventions are being tested in trial NCT00695110?

The interventions under investigation include: Oral testosterone undecanoate (TU) (300 mg T equivalents/dose) (DRUG), Oral testosterone undecanoate (TU) combined with testosterone enanthate (TE) (400 mg T equivalents/dose) (DRUG), Oral testosterone undecanoate (TU) (200 mg T equivalents/dose with and without food) (DRUG), Oral testosterone undecanoate (TU) combined with testosterone enanthate (TE) (300 mg T equivalents/dose) (DRUG).

Who is sponsoring clinical trial NCT00695110?

This trial is sponsored by Clarus Therapeutics, which has 11 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00695110's enrollment target sits among peer trials

29 1669th of 2000 higher than 324 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT00695110, the US trial registry maintained by the National Library of Medicine. NCT00695110 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.