# Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU) in Hypogonadal Men

> **NCT01403116** · PHASE3 · COMPLETED · sponsor: **Clarus Therapeutics, Inc.** · enrollment: 325 (actual)

## Conditions studied

- Male Hypogonadism

## Interventions

- **DRUG:** Oral testosterone undecanoate
- **DRUG:** topical testosterone gel

## Key facts

- **NCT ID:** NCT01403116
- **Lead sponsor:** Clarus Therapeutics, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2011-07
- **Primary completion:** 2013-09
- **Final completion:** 2013-09
- **Target enrollment:** 325 (ACTUAL)
- **Last updated:** 2018-08-14

## Collaborators

- [object Object]
- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01403116

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01403116, "Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU) in Hypogonadal Men". Retrieved via AI Analytics 2026-06-01 from https://api.ai-analytics.org/clinical/NCT01403116. Licensed CC0.

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