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

Solvay

Status and phase: Completed; Phase 1

Conditions: Hypogonadism

Treatments: Drug: Testosterone gel 1.62%

Study type: Interventional

Funder types: Industry

Identifiers

NCT00998933

S176.1.009

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

1

Experimental group

Treatment:

Drug: Testosterone gel 1.62%