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

This study has been completed.
Information provided by:
Solvay Pharmaceuticals Identifier:
First received: October 20, 2009
Last updated: November 24, 2009
Last verified: November 2009

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

Condition Intervention Phase
Drug: Testosterone gel 1.62%
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label Study of Serum Testosterone Levels in Non-dosed Females After Secondary Exposure to Testosterone Gel 1.62%

Resource links provided by NLM:

Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:
  • Pharmacokinetic Parameters Total Testosterone AUC, Cav, Cmax [ Time Frame: 4 days ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: October 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Testosterone gel 1.62%
5 grams applied topically to upper arms/shoulder and abdomen on Day 1


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
Please refer to this study by its identifier: NCT00998933

United States, Florida
Site 1
Miami Gardens, Florida, United States
Sponsors and Collaborators
Solvay Pharmaceuticals
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
  More Information

No publications provided by Solvay Pharmaceuticals

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Barbara Parker, Solvay Pharmaceuticals Identifier: NCT00998933     History of Changes
Other Study ID Numbers: S176.1.009
Study First Received: October 20, 2009
Last Updated: November 24, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Solvay Pharmaceuticals:
Testosterone replacement therapy

Additional relevant MeSH terms:
Gonadal Disorders
Endocrine System Diseases
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents processed this record on April 16, 2014