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Single-Dose Pharmacokinetics of Oral Testosterone Undecanoate With and Without Concomitant Inhibition of UGT2B17

NCT06312761 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-03-15

No results posted yet for this study

Summary

This study will be performed in normal men whose endogenous testosterone production has been temporarily suppressed by the administration of a single dose of 120 mg of the oral GnRH antagonist Relugolix, which is approved for the treatment of prostate cancer, and can suppress endogenous testosterone biosynthesis for 48-72 hours after a single dose.

Conditions

  • Hypogonadism, Male

Interventions

DRUG

Relugolix 120Mg Tab

Relugolix 120 mg single dose - All subjects

DIETARY_SUPPLEMENT

Curcumin

Curcumin 630 mg single dose

DRUG

Testosterone Undecanoate 237 MG Oral Capsule

Testosterone Undecanoate 237 MG Oral Capsule

Sponsors & Collaborators

Principal Investigators

  • John Amory, MD · University of Washington

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-01
Primary Completion
2025-12-31
Completion
2025-12-31

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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 NCT06312761 on ClinicalTrials.gov