CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 74 enrolled
Drug / intervention
Test formulation +1 morebiological
Likely dose
Test formulation 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03792477
NCT03792477Phase 1Completed
CompareCT.gov

A PHASE 1, OPEN-LABEL, RANDOMIZED, 2-TREATMENT SINGLE-DOSE, CROSS-OVER STUDY, 2-PART DESIGN TO EVALUATE THE BIOEQUIVALENCE AND TOLERABILITY OF TESTOSTERONE CYPIONATE FOLLOWING INTRAMUSCULAR (IM) INJECTION IN HEALTHY HYPOGONADAL MALE SUBJECTS

Pfizer·interventional·Posted Jan 3, 2019·Updated Apr 29, 2021

In Brief

A Phase 1 clinical trial evaluating Test formulation and Reference formulation for Hypogonadism. Completed, enrolled 74 participants across 2 sites.

Detailed Summary

This is an open-label, 2-treatment, 2-period, single dose (200 mg, IM) cross-over study, 2-part design to evaluate the bioequivalence (BE) of a reformulated presentation (test) of testosterone cypionate solution for injection relative to the currently approved marked formulation (reference). In the first part of the study (Part 1), an estimate of the exposure variability will be evaluated for both test and reference. This will help guide sample size in Part 2. Part 2 will be powered to assess the BE of both test and reference formulations.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypogonadism
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedJan 3, 2019
Enrollment StartJan 19, 2019
Primary CompletionApr 2, 2020
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 7.5 years ago

Interventions

Test formulationbiological

A single testosterone cypionate solution for injection (new formulation) 200 mg dose administered IM deep in the gluteal muscle (Test formulation).

Reference formulationbiological

A single testosterone cypionate solution for injection (currently marketed formulation) 200 mg dose administered IM deep in the gluteal muscle (Reference formulation).