Trials / Completed
CompletedNCT02081300
Safety and Efficacy of Oral LPCN 1021 in Men With Low Testosterone or Hypogonadism
Phase 3, Active-Controlled, Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU, LPCN 1021) in Hypogonadal Men
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 315 (actual)
- Sponsor
- Lipocine Inc. · Industry
- Sex
- Male
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine the safety and efficacy of an oral testosterone undecanoate formulation for use as testosterone-replacement therapy in men with low testosterone.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Oral testosterone undecanoate, LPCN 1021 | |
| DRUG | Topical testosterone gel 1.62 % |
Timeline
- Start date
- 2014-02-01
- Primary completion
- 2015-05-01
- Completion
- 2015-05-01
- First posted
- 2014-03-07
- Last updated
- 2017-10-23
Source: ClinicalTrials.gov record NCT02081300. Inclusion in this directory is not an endorsement.