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)	Phase III

Further Study Details: 

Primary Outcomes: Total satisfying sexual activity over 24 weeks
Secondary Outcomes: Sexual desire; personal distress; other domains of the Profile of Female Sexual Function over 24 weeks; mood, energy and well-being; menopausal symptoms
Expected Total Enrollment:  750

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.

Detailed Description:

Ages Eligible for Study:  20 Years   -   70 Years,  Genders Eligible for Study:  Female

Criteria

Inclusion Criteria:

1. Be a generally healthy surgically menopausal woman (12 months), 20 to 70 years of age, not receiving any systemic estrogen or estrogen progestin therapy
2. 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.
3. 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.

4. Answer affirmatively to ALL of the following questions:

   1. Before your menopause, would you say that in general, your sex life was good and satisfying?
   2. Since your menopause, do you feel you have experienced a meaningful loss in your level of desire for sex?
   3. Since your menopause, do you feel you have experienced a significant decrease in your sexual activity?
   4. Are you concerned about or bothered by your current level of desire for or interst in sex?

   5. Would you like to see an increase in your level of interest in or desire for sex and sexual activity?

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Exclusion Criteria:

1. Physical limitations that would interfere with normal sexual function;
2. Estrogen use in the last 12 weeks (vaginal estriol or low dose vaginal estradiol accepted);
3. 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, SSRIs, tricyclic anti-depressants, anti-androgens, systemic beta-blockers, anti-adrenergics, spironolactone, apomorphine, PDE5 inhibitors (e.g., Viagra,tibolone or SERMs, including tamoxifen (last 12 weeks);
4. Be experiencing any chronic or acute life stress relating to any major life change that may significantly interfere with sexual function;
5. Have significant psychiatric disorder (including mild depressive disorder - Beck Depression Inventory-II score of > 14;
6. 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
7. Have evidence of or history of malignancy (estrogen dependent or any gynecological cancer) within the last 5 years;
8. 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 completng the study, or otherwise affect the outcome of the study.

Have signicant abnormal pretreatment laboratory parameters.

Australia, Victoria
      Monash Medical School, The Alfred Hospital, Prahran,  Victoria,  VIC 3181,  Australia

Study chairs or principal investigators

Sue Davis, MD,  Principal Investigator,  Monash Medical School, The Alfred Hospital   

Study ID Numbers:  2004031
Last Updated:  August 17, 2005
Record first received:  August 16, 2005
ClinicalTrials.gov Identifier:  NCT00131495
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13