Study of Transdermal Testosterone Patches in Menopausal Women With Low Libido

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Warner Chilcott
ClinicalTrials.gov Identifier:
NCT00131495
First received: August 16, 2005
Last updated: April 15, 2013
Last verified: April 2013
  Purpose

This study is designed to evaluate the efficacy and safety of 2 doses of the transdermal testosterone patch in naturally or surgically menopausal women with low libido who are not receiving systemic estrogen or estrogen progestin therapy.


Condition Intervention Phase
Hypoactive Sexual Desire Disorder
Drug: Testosterone (transdermal patches)
Drug: Placebo patch
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-controlled, Parallel-group, 52-week Study to Evaluate the Efficacy/Safety of Transdermal Patches Delivering Testosterone in Menopausal Women With Low Libido Not Receiving Estrogen Therapy

Resource links provided by NLM:


Further study details as provided by Warner Chilcott:

Primary Outcome Measures:
  • Total satisfying sexual activity over 24 weeks [ Time Frame: 6, 12, 24, 36, and 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sexual desire [ Time Frame: 6, 12, 24, 36, and 52 weeks ] [ Designated as safety issue: No ]
  • personal distress [ Time Frame: 6, 12, 24, 36, and 52 weeks ] [ Designated as safety issue: No ]
  • other domains of the Profile of Female Sexual Function over 24 weeks [ Time Frame: 6, 12, 24, 36, and 52 weeks ] [ Designated as safety issue: No ]
  • mood, energy and well-being [ Time Frame: 6, 12, 24, 36, and 52 weeks ] [ Designated as safety issue: No ]
  • menopausal symptoms [ Time Frame: 6, 12, 24, 36, and 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 814
Study Start Date: July 2004
Study Completion Date: February 2007
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo patch
Drug: Placebo patch
placebo patch changed twice a week for one year
Experimental: 2
Testosterone patch (300mcg/day, changed twice a week for one year
Drug: Testosterone (transdermal patches)
Testosterone patch (300mcg/day, changed twice a week for one year

Detailed Description:

Detailed Description:

Hypoactive sexual desire disorder (HSDD) is a condition suffered by as many as 32% of the menopausal population. It is generally defined as a low libido which causes distress. Testosterone therapy (transdermal patch) is currently under investigation for this disorder and results of three phase 3 trials have shown evidence of efficacy in menopausal patients on hormone replacement therapy. Low libido does not discriminate between those women utilizing hormone replacement therapy and those who do not. This study is designed to evaluate the efficacy and safety of 2 doses of the transdermal testosterone patch in naturally or surgically menopausal women with low libido who are not receiving systemic estrogen or estrogen progestin therapy. Persons could elect to go into a single blind study for one year after completing the first yeat double blind

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be a generally healthy surgically menopausal woman (12 months), 20 to 70 years of age, not receiving any systemic estrogen or estrogen progestin therapy
  • Be a generally healthy naturally menopausal woman (2 years since last period), 40 to 70 years of age, not receiving any systemic estrogen or estrogen progestin therapy.
  • Be, in their own judgment, in a stable monogamous sexual relationship for at least one year prior to study entry that is perceived to be secure and communicative with the same partner who is sexually functional and physically present at least 50% of the time.
  • Answer affirmatively to ALL of the following questions:

    1. Was the patient's sex life before menopause good and satisfying in general?
    2. Since menopause, has a meaningful loss in the level of desire for sex occurred?
    3. Since menopause, has a significant decrease in sexual activity occurred?
    4. Is the current level of desire for or interest in sex bothering or concerning?
    5. Is an increase in the level of interest in or desire for sex and sexual activity desired?

Exclusion Criteria:

  • Physical limitations that would interfere with normal sexual function;
  • Estrogen use in the last 12 weeks (vaginal estriol or low dose vaginal estradiol accepted)
  • Use of any of the following medications:

    • antiandrogen therapy or topical minoxidil (last 5 years),
    • androgen therapy (past 3 months/implantable past 7 months),
    • systemic corticosteroids,
    • selective serotonin reuptake inhibitors (SSRIs),
    • tricyclic anti-depressants,
    • anti-androgens,
    • systemic beta-blockers,
    • anti-adrenergics,
    • spironolactone,
    • apomorphine,
    • phosphodiesterase type 5 (PDE5) inhibitors (e.g., Viagra, tibolone or selective estrogen receptor modulators (SERMs), including tamoxifen (last 12 weeks))
  • Be experiencing any chronic or acute life stress relating to any major life change that may significantly interfere with sexual function;
  • Have significant psychiatric disorder (including mild depressive disorder - Beck Depression Inventory-II score of > 14;
  • Have current severe dermatological problems or a known suspected hypersensitivity or allergy to any adhesive or any of the constituents of the transdermal testosterone patch
  • Have evidence of or history of malignancy (estrogen dependent or any gynecological cancer) within the last 5 years;
  • Have diabetes mellitus, active gallbladder disease, unstable thyroid disease, history of cerebrovascular disease, thrombo-embolic disorders, myocardial infarction or angina within the last 5 years or other significant organic disease that would prevent the patient from completing the study, or otherwise affect the outcome of the study.
  • Have significant abnormal pretreatment laboratory parameters.
  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: NCT00131495

Locations
Australia, Victoria
Monash Medical School, The Alfred Hospital
Prahran, Victoria, Australia, VIC 3181
Sponsors and Collaborators
Warner Chilcott
Investigators
Principal Investigator: Sue Davis, MD Monash Medical School, The Alfred Hospital
  More Information

No publications provided by Warner Chilcott

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT00131495     History of Changes
Other Study ID Numbers: 2004031 and Yr 2 SB
Study First Received: August 16, 2005
Last Updated: April 15, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Warner Chilcott:
Low Libido
Low Desire
Distress

Additional relevant MeSH terms:
Sexual Dysfunctions, Psychological
Hypokinesia
Sexual and Gender Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
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 August 21, 2014