# Safety and Efficacy of Oral LPCN 1021 in Men With Low Testosterone or Hypogonadism

> **NCT02081300** · PHASE3 · COMPLETED · sponsor: **Lipocine Inc.** · enrollment: 315 (actual)

## Conditions studied

- Male Hypogonadism

## Interventions

- **DRUG:** Oral testosterone undecanoate, LPCN 1021
- **DRUG:** Topical testosterone gel 1.62 %

## Key facts

- **NCT ID:** NCT02081300
- **Lead sponsor:** Lipocine Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2014-02
- **Primary completion:** 2015-05
- **Final completion:** 2015-05
- **Target enrollment:** 315 (ACTUAL)
- **Last updated:** 2017-10-23

## Collaborators

- [object Object]
- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT02081300

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT02081300, "Safety and Efficacy of Oral LPCN 1021 in Men With Low Testosterone or Hypogonadism". Retrieved via AI Analytics 2026-09-13 from https://api.ai-analytics.org/clinical/NCT02081300. Licensed CC0.

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