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Efficacy and Safety of Oral Testosterone Undecanoate in Hypogonadal Men

NCT03198728 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 314

Last updated 2023-06-28

Study results available
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Summary

This will be a randomized, multicenter, open-label, active-controlled, efficacy, and safety study in adult hypogonadal men. The study duration is 12 months (365 days), including a 90-day, open-label efficacy period and a 9-month (275-day) safety evaluation period.

Conditions

  • Hypogonadism, Male

Interventions

DRUG

SOV2012-F1

oral preparation of testosterone undecanoate (TU)

DRUG

AndroGel

topical testosterone gel 1.62%

Sponsors & Collaborators

  • Syneos Health

    collaborator OTHER

  • Marius Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Alastair Smith, MB, ChB · Syneos Health

  • Om Dhingra, PhD · Marius Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-05
Primary Completion
2020-05-01
Completion
2020-05-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03198728 on ClinicalTrials.gov