Drug intelligence / Profile preview

Placebo Gel (Repros Therapeutics)

Development stage
Unknown
Lead developer
Allergan
Administration
Topical
01

Overview

A pharmacologically inactive topical gel used as a control in clinical trials conducted by Repros Therapeutics. It was specifically utilized in Phase 3 studies, including the ZA-304 trial, evaluating Androxal (enclomiphene citrate) for the treatment of secondary hypogonadism (acquired hypogonadotropic hypogonadism) in men. The placebo gel was designed to be indistinguishable from AndroGel 1.62% to facilitate a double-blind, double-dummy trial design, where it served as the negative control for the topical testosterone arm. This allowed researchers to isolate the effects of the oral selective estrogen receptor modulator (SERM) Androxal while maintaining the blinding of patients and investigators who were also comparing it to a topical testosterone replacement therapy.

Other names
Placebo Gel

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