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
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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:
Endocrine System Diseases
Gonadal Disorders
Testosterone 17 beta-cypionate
Testosterone enanthate
Testosterone undecanoate
Anabolic Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on October 06, 2015