Study of Serum Testosterone Levels in Non-dosed Females After Secondary Exposure

Phase 1CompletedNCT00998933

Solvay Pharmaceuticals24 enrolled

Overview

To further characterize the transfer potential of marketed testosterone gel and new 1.62% formulation.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypogonadism

Interventions

Testosterone gel 1.62%DRUG

5 grams applied topically to upper arms/shoulder and abdomen on Day 1

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy male and female volunteers, with a BMI 20-35 kg/m2 (males) and 20-30 kg/m2 (females). Exclusion Criteria: * Males: history, current or suspected prostate or breast cancer. * Female: pregnant or lactating.

Locations (1)

Site 1

Miami Gardens, Florida, United States

Outcomes

Primary Outcomes

Pharmacokinetic Parameters Total Testosterone AUC, Cav, Cmax

Time frame: 4 days

Data from ClinicalTrials.gov

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