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

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ClinicalTrials.gov Identifier: NCT00998933
Recruitment Status : Completed
First Posted : October 21, 2009
Last Update Posted : November 25, 2009
Information provided by:
Solvay Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Hypogonadism Drug: Testosterone gel 1.62% Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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%
Study Start Date : October 2009
Primary Completion Date : October 2009
Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: Testosterone gel 1.62%
5 grams applied topically to upper arms/shoulder and abdomen on Day 1

Primary Outcome Measures :
  1. Pharmacokinetic Parameters Total Testosterone AUC, Cav, Cmax [ Time Frame: 4 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00998933

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Barbara Parker, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00998933     History of Changes
Other Study ID Numbers: S176.1.009
First Posted: October 21, 2009    Key Record Dates
Last Update Posted: November 25, 2009
Last Verified: November 2009

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
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents