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NCT01534208 · ClinicalTrials.gov registry record · Phase 3

Safety Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism

A Phase 3 study, sponsored by Repros Therapeutics.

Completed
Registry status
Phase 3
Development phase
499
Enrollment target

NCT01534208: Completed Phase 3 study, sponsored by Repros Therapeutics.

NCT01534208 is a Phase 3 study that has completed, run by Repros Therapeutics. The registered enrollment target is 499 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01534208, a Phase 3 study, has completed, sponsored by Repros Therapeutics.

COMPLETED
Registry status
Phase 3
Development phase
499 participants
Enrollment target

Study Summary

ZA-300 is meant to determine the safety profile of Androxal (enclomiphene citrate) in men with secondary hypogonadism.

Primary Outcome

Changes in values from baseline of total morning testosterone levels at Week 26

Interventions

  • DRUG Androxal

Trial Details

FieldValue
Enrollment Target 499 participants
Start Date 2012-05
Est. Completion 2013-10
Phase Phase 3
Repros Therapeutics

50 total trials

What the finished NCT01534208 record still lists

NCT01534208 is an interventional study that assigns participants to a tested intervention. The registered 499 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% lower).

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

NCT01534208 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01534208 about?

NCT01534208 is a clinical study titled "Safety Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism". ZA-300 is meant to determine the safety profile of Androxal (enclomiphene citrate) in men with secondary hypogonadism.

What is the current status of trial NCT01534208?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 499 participants. The study started on 2012-05. Estimated completion is 2013-10.

What interventions are being tested in trial NCT01534208?

The interventions under investigation include: Androxal (DRUG).

Who is sponsoring clinical trial NCT01534208?

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 NCT01534208's enrollment target sits among peer trials

499 775th of 2000 higher than 1,226 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT01534208, the US trial registry maintained by the National Library of Medicine. NCT01534208 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.