A Bioequivalence Study of Testosterone Cypionate in Hypogonadal Males

PHASE1CompletedINTERVENTIONAL
Enrollment

74

Participants

Timeline

Start Date

January 19, 2019

Primary Completion Date

April 2, 2020

Study Completion Date

April 2, 2020

Conditions
Hypogonadism
Interventions
BIOLOGICAL

Test formulation

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

BIOLOGICAL

Reference formulation

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

Trial Locations (2)

32720

Avail Clinical Research, DeLand

33136

Syneos Health, Miami

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY