A Pharmacokinetic (PK) Study to Compare the Absorption of Two Formulations of Transdermal Testosterone Spray and Intrinsa®

NCT01096329 | Terminated Phase 1

• 1 other identifier: VTS-102
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if the absorption of the testosterone spray is the same as the Intrinsa® Patch.

Conditions

Hypoactive Sexual Desire Disorder

Keywords

postmenopausal; hormone replacement therapy

Outcome Measures

Primary Outcomes (1)

• To measure the amount of testosterone in the blood after dosing

  The following PK parameters of testosterone will be measured AUC0-24, AUC0-48, AUC0-72, AUC0-96, Cavg, Cmin, Cmax

  2 months

Study Arms (3)

Cohort 2

ACTIVE COMPARATOR

Testosterone Spray (5%) vs Intrinsa® Patch

Drug: Intrinsa® Patch and Testosterone Spray 5%

Cohort 3

ACTIVE COMPARATOR

Testosterone Spray (1%) vs Intrinsa® Patch

Drug: Intrinsa® Patch and Testosterone Spray 1%

Cohort 1

ACTIVE COMPARATOR

Testosterone Spray (5%) vs Testosterone Spray (1%)

Drug: Testosterone Spray 5% and 1%

Interventions

Testosterone Spray 5% and 1% DRUG

Testosterone Spray 5% 2x90uL for 14 days Testosterone Spray 1% 2x90uL for 14 days

Cohort 1

Intrinsa® Patch and Testosterone Spray 5% DRUG

Testosterone Spray 5% 2x90uL for 14 days Intrinsa® Patch for 14 days

Cohort 2

Intrinsa® Patch and Testosterone Spray 1% DRUG

Testosterone Spray 1% 2x90uL for 14 days Intrinsa® Patch for 14 days

Cohort 3

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written Informed Consent
• Naturally or surgically postmenopausal females, 45 - 65 years of age
• Subjects have spontaneous amenorrhea for at least 12 months
• Subjects have a serum total testosterone level of \< 30 ng/dL
• Subjects currently on a stable dose of prescribed oral or transdermal estrogen replacement therapy (ERT) for a period of at least 8 to 12 weeks prior to screening, respectively, or not on ERT.
• A body weight of at least 50 kg and a body mass index (BMI) between 18 and 35 kg/m2, inclusive \[BMI will be calculated as weight in kg/(height in m)2\]
• Medically healthy, with clinically insignificant screening results (e.g., laboratory profiles, medical histories, ECGs, physical examination (including breast examination), in the opinion of the Investigator.
• Subjects are able to communicate with the Investigator, and to understand and to comply with all requirements of study participation.
• An adequate washout period prior to obtaining any baseline assessments in women who have been previously treated for postmenopausal symptoms. Calculated from study Day 1, the minimum washout period will be 2 and 4 weeks for prior treatment with testosterone oral and transdermal products, respectively, 3 months for prior treatment with testosterone implants and 2 weeks for treatment with estratest.

You may not qualify if:

• A positive serum pregnancy test at screening
• A history or presence of significant cardiovascular, neurological, hematological, psychiatric, hepatic, gastrointestinal, pulmonary, endocrine, immunologic or renal disease or other condition known to interfere with the transdermal absorption, distribution, metabolism, or excretion of drugs or place the subjects at increased risk as determined by the Investigator
• Any clinically significant laboratory abnormalities as judged by the Investigator
• Subjects are experiencing \> 20 hot flushes per week
• Subjects are suffering from severe acne, moderate to severe hirsutism or androgenic alopecia, or have a history of severe dermatological problems or drug-induced contact dermatitis
• Systolic blood pressure \> 150 mm Hg or diastolic blood pressure \> 95 mm Hg at screening or prior to the first dosing in this study (two rechecks are allowed)
• Any malignancy except basal cell carcinoma
• A significant psychiatric disorder (e.g., major depression, etc.) that might, in the Investigator's opinion, prevent the subject from completing the study
• Currently smoke more than 10 cigarettes a day
• A history of breast biopsy with atypical hyperplasia
• A prior history of breast cancer, suspected breast cancer, or other current or prior cancer within the past 10 years
• Exhibits anemia, defined as a hemoglobin level at screening below the laboratory's lower limit of normal reference range
• Diabetes mellitus
• Any chronic skin disorder (e.g., eczema, psoriasis) likely to interfere with transdermal drug absorption or assessments of skin tolerability
• Positive urine drug test and/or positive breath alcohol test at screening or prior to the first dosing in this study (Period 1 only)

Sponsors & Collaborators

• VIVUS LLC: lead

Study Sites (1)

MDS Pharma Services

Tempe, Arizona, 85283, United States

Location

MeSH Terms

Conditions

Sexual Dysfunctions, Psychological

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Mark Allison, MD

  MDS Pharma Services Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 28, 2010
• First Posted: March 31, 2010
• Study Start: February 1, 2010
• Primary Completion: April 1, 2010
• Last Updated: June 8, 2011

Record last verified: 2011-06

Locations

US (1)