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Study of Transdermal Testosterone Patches in Menopausal Women With Low Libido

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE August 16, 2005
First Posted Date  ICMJE August 18, 2005
Last Update Posted Date April 17, 2013
Study Start Date  ICMJE July 2004
Actual Primary Completion Date February 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2008)
Total satisfying sexual activity over 24 weeks [ Time Frame: 6, 12, 24, 36, and 52 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 16, 2005)
Total satisfying sexual activity over 24 weeks
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2008)
  • Sexual desire [ Time Frame: 6, 12, 24, 36, and 52 weeks ]
  • personal distress [ Time Frame: 6, 12, 24, 36, and 52 weeks ]
  • other domains of the Profile of Female Sexual Function over 24 weeks [ Time Frame: 6, 12, 24, 36, and 52 weeks ]
  • mood, energy and well-being [ Time Frame: 6, 12, 24, 36, and 52 weeks ]
  • menopausal symptoms [ Time Frame: 6, 12, 24, 36, and 52 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2005)
  • Sexual desire
  • personal distress
  • other domains of the Profile of Female Sexual Function over 24 weeks
  • mood, energy and well-being
  • menopausal symptoms
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Transdermal Testosterone Patches in Menopausal Women With Low Libido
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hypoactive Sexual Desire Disorder
Intervention  ICMJE
  • Drug: Testosterone (transdermal patches)
    Testosterone patch (300mcg/day, changed twice a week for one year
  • Drug: Placebo patch
    placebo patch changed twice a week for one year
Study Arms  ICMJE
  • Placebo Comparator: 1
    Placebo patch
    Intervention: Drug: Placebo patch
  • Experimental: 2
    Testosterone patch (300mcg/day, changed twice a week for one year
    Intervention: Drug: Testosterone (transdermal patches)
Publications * Davis SR, Moreau M, Kroll R, Bouchard C, Panay N, Gass M, Braunstein GD, Hirschberg AL, Rodenberg C, Pack S, Koch H, Moufarege A, Studd J; APHRODITE Study Team. Testosterone for low libido in postmenopausal women not taking estrogen. N Engl J Med. 2008 Nov 6;359(19):2005-17. doi: 10.1056/NEJMoa0707302.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 6, 2008)
814
Original Enrollment  ICMJE
 (submitted: August 16, 2005)
750
Actual Study Completion Date  ICMJE February 2007
Actual Primary Completion Date February 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00131495
Other Study ID Numbers  ICMJE 2004031 and Yr 2 SB
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Warner Chilcott
Study Sponsor  ICMJE Warner Chilcott
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sue Davis, MD Monash Medical School, The Alfred Hospital
PRS Account Warner Chilcott
Verification Date April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP