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

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Solvay Pharmaceuticals
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

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.