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

This study has been terminated.
Sponsor:
Information provided by:
VIVUS, Inc.
ClinicalTrials.gov Identifier:
NCT01096329
First received: March 28, 2010
Last updated: June 6, 2011
Last verified: June 2011
  Purpose

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


Condition Intervention Phase
Hypoactive Sexual Desire Disorder
Drug: Testosterone Spray 5% and 1%
Drug: Intrinsa® Patch and Testosterone Spray 5%
Drug: Intrinsa® Patch and Testosterone Spray 1%
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase 1, Open-label, Randomized, Three-cohort, Two-period Crossover Study to Determine the Relative Bioavailability of Testosterone Following Application of Two Testosterone Transdermal Spray (TTS) Formulations Once Daily and Intrinsa® Patch Twice Weekly in Healthy, Surgically and Naturally Post-menopausal Women Receiving Estrogen Replacement Therapy

Resource links provided by NLM:


Further study details as provided by VIVUS, Inc.:

Primary Outcome Measures:
  • To measure the amount of testosterone in the blood after dosing [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    The following PK parameters of testosterone will be measured AUC0-24, AUC0-48, AUC0-72, AUC0-96, Cavg, Cmin, Cmax


Enrollment: 16
Study Start Date: February 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cohort 2
Testosterone Spray (5%) vs Intrinsa® Patch
Drug: Intrinsa® Patch and Testosterone Spray 5%
Testosterone Spray 5% 2x90uL for 14 days Intrinsa® Patch for 14 days
Active Comparator: Cohort 3
Testosterone Spray (1%) vs Intrinsa® Patch
Drug: Intrinsa® Patch and Testosterone Spray 1%
Testosterone Spray 1% 2x90uL for 14 days Intrinsa® Patch for 14 days
Active Comparator: Cohort 1
Testosterone Spray (5%) vs Testosterone Spray (1%)
Drug: Testosterone Spray 5% and 1%
Testosterone Spray 5% 2x90uL for 14 days Testosterone Spray 1% 2x90uL for 14 days

  Eligibility

Ages Eligible for Study:   45 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Written Informed Consent
  2. Naturally or surgically postmenopausal females, 45 - 65 years of age
  3. Subjects have spontaneous amenorrhea for at least 12 months
  4. Subjects have a serum total testosterone level of < 30 ng/dL
  5. 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.
  6. 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]
  7. 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.
  8. Subjects are able to communicate with the Investigator, and to understand and to comply with all requirements of study participation.
  9. 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.

Exclusion Criteria:

  1. A positive serum pregnancy test at screening
  2. 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
  3. Any clinically significant laboratory abnormalities as judged by the Investigator
  4. Subjects are experiencing > 20 hot flushes per week
  5. 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
  6. 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)
  7. Any malignancy except basal cell carcinoma
  8. A significant psychiatric disorder (e.g., major depression, etc.) that might, in the Investigator's opinion, prevent the subject from completing the study
  9. Currently smoke more than 10 cigarettes a day
  10. A history of breast biopsy with atypical hyperplasia
  11. A prior history of breast cancer, suspected breast cancer, or other current or prior cancer within the past 10 years
  12. Exhibits anemia, defined as a hemoglobin level at screening below the laboratory's lower limit of normal reference range
  13. Diabetes mellitus
  14. Any chronic skin disorder (e.g., eczema, psoriasis) likely to interfere with transdermal drug absorption or assessments of skin tolerability
  15. Positive urine drug test and/or positive breath alcohol test at screening or prior to the first dosing in this study (Period 1 only)
  16. Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV) at screening
  17. Any history or presence of alcoholism or drug or substance abuse as defined by the Investigator
  18. A history of hypersensitivity or idiosyncratic reaction to testosterone, octisalate, PEG 200, IPA, or other sunscreens, or alcohol-based skin products or Intrinsa®
  19. Use of any prescription (except estrogen replacement therapy) or over-the-counter (OTC) medication, within the 30 days prior to the first dosing in this study. Up to 2 g per day of acetaminophen is allowed at the discretion of the Investigator
  20. Use of any drugs known to have clinical significance in inhibiting or inducing liver enzymes involved in drug metabolism [CYP P450]) within 30 days prior to the first dosing in this study. Use of any systemic corticosteroids within 30 days prior to the first dosing in this study
  21. Blood donation or significant blood loss within 56 days prior to the first dosing in this study. Any contraindication to blood sampling
  22. Plasma donation within 7 days prior to the first dosing in this study
  23. Currently using or has a history of any androgen use within 6 months prior to screening, or uses dehydroepiandrosterone (DHEA) >/= 25 mg per day, or St. John's Wort within 4 weeks prior to baseline. Due to large number of herbal remedies available, all other herbal supplements will be reviewed by the Sponsor during screening
  24. Currently using estratest (esterified estrogens and methyltestosterone)
  25. Use of an investigational drug within 30 days or six half-lives, whichever is longer, prior to the first dosing in this study
  26. Clinical judgment by the Investigator that the subject should not participate in the study
  27. Involvement in the planning and conduct of the study (applies to both VIVUS and designee staff, and staff at the investigational site)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01096329

Locations
United States, Arizona
MDS Pharma Services
Tempe, Arizona, United States, 85283
Sponsors and Collaborators
VIVUS, Inc.
Investigators
Principal Investigator: Mark Allison, MD MDS Pharma Services Inc
  More Information

No publications provided

Responsible Party: Wes Day, PhD/VP Clinical, Vivus Inc
ClinicalTrials.gov Identifier: NCT01096329     History of Changes
Other Study ID Numbers: VTS-102
Study First Received: March 28, 2010
Last Updated: June 6, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by VIVUS, Inc.:
postmenopausal
hormone replacement therapy

Additional relevant MeSH terms:
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on September 16, 2014