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Study of Transdermal Testosterone Patches in Menopausal Women With Low Libido

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ClinicalTrials.gov Identifier: NCT00131495
Recruitment Status : Completed
First Posted : August 18, 2005
Last Update Posted : April 17, 2013
Sponsor:
Information provided by (Responsible Party):
Warner Chilcott

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Hypoactive Sexual Desire Disorder Drug: Testosterone (transdermal patches) Drug: Placebo patch Phase 3

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 814 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : July 2004
Actual Primary Completion Date : February 2006
Actual Study Completion Date : February 2007

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Total satisfying sexual activity over 24 weeks [ Time Frame: 6, 12, 24, 36, and 52 weeks ]

Secondary Outcome Measures :
  1. Sexual desire [ Time Frame: 6, 12, 24, 36, and 52 weeks ]
  2. personal distress [ Time Frame: 6, 12, 24, 36, and 52 weeks ]
  3. other domains of the Profile of Female Sexual Function over 24 weeks [ Time Frame: 6, 12, 24, 36, and 52 weeks ]
  4. mood, energy and well-being [ Time Frame: 6, 12, 24, 36, and 52 weeks ]
  5. menopausal symptoms [ Time Frame: 6, 12, 24, 36, and 52 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes 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
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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): NCT00131495


Locations
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Australia, Victoria
Monash Medical School, The Alfred Hospital
Prahran, Victoria, Australia, VIC 3181
Sponsors and Collaborators
Warner Chilcott
Investigators
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Principal Investigator: Sue Davis, MD Monash Medical School, The Alfred Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT00131495    
Other Study ID Numbers: 2004031 and Yr 2 SB
First Posted: August 18, 2005    Key Record Dates
Last Update Posted: April 17, 2013
Last Verified: April 2013
Keywords provided by Warner Chilcott:
Low Libido
Low Desire
Distress
Additional relevant MeSH terms:
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Sexual Dysfunctions, Psychological
Mental Disorders
Testosterone
Androgens
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs