Clinical trial NCT00131495: Study of Transdermal Testosterone Patches in Menopausal Women With Low Libido
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypoactive Sexual Desire Disorder
Keywords: Low Libido
Low Desire
Distress
Lead sponsor: Warner Chilcott
Sponsor class: INDUSTRY
First posted: 2005-08-18
Enrollment: 814
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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.

Primary outcomes:
measure: Total satisfying sexual activity over 24 weeks
timeFrame: 6, 12, 24, 36, and 52 weeks
Secondary outcomes:
measure: Sexual desire
timeFrame: 6, 12, 24, 36, and 52 weeks
measure: personal distress
timeFrame: 6, 12, 24, 36, and 52 weeks
measure: other domains of the Profile of Female Sexual Function over 24 weeks
timeFrame: 6, 12, 24, 36, and 52 weeks
measure: mood, energy and well-being
timeFrame: 6, 12, 24, 36, and 52 weeks
measure: menopausal symptoms
timeFrame: 6, 12, 24, 36, and 52 weeks
Other outcomes:
Locations:
city: Prahran
country: Australia
facility: Monash Medical School, The Alfred Hospital
state: Victoria
Study officials:
affiliation: Monash Medical School, The Alfred Hospital
name: Sue Davis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.