Study of Transdermal Testosterone Patches in Surgically Menopausal Women With Low Libido

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Warner Chilcott
ClinicalTrials.gov Identifier:
NCT00331123
First received: May 26, 2006
Last updated: April 15, 2013
Last verified: April 2013

May 26, 2006
April 15, 2013
May 2002
December 2003   (final data collection date for primary outcome measure)
To assess the efficacy of testosterone transdermal system (TTS) as measured by the change from baseline in the frequency of total satisfying sexual activity captured by the Sexual Activity Log (SAL). [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
To assess the efficacy of testosterone transdermal system (TTS) as measured by the change from baseline in the frequency of total satisfying sexual activity captured by the Sexual Activity Log (SAL).
Complete list of historical versions of study NCT00331123 on ClinicalTrials.gov Archive Site
To assess the efficacy measured by the change from baseline in sexual desire; personal distress as measured by the Personal Distress Scale score; the other 6 domains of the profile of Female Sexual Function; and the other 8 SAL endpoints. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
To assess the efficacy measured by the change from baseline in sexual desire; personal distress as measured by the Personal Distress Scale score; the other 6 domains of the profile of Female Sexual Function; and the other 8 SAL endpoints.
Not Provided
Not Provided
 
Study of Transdermal Testosterone Patches in Surgically Menopausal Women With Low Libido
Study to Evaluate Efficacy and Safety of Transdermal Testosterone and Safety for an Open-label Period in Women With Hypoactive Sexual Desire Disorder on Estrogen Replacement Therapy and Undergone Hysterectomy/Bilateral Oophorectomy.

This study is designed to evaluate efficacy and safety of a testosterone patch as treatment for low libido in surgically menopausal women who are taking estrogen therapy.

Women with hypoactive sexual desire disorder (HSDD) who had undergone bilateral salpingo-oophorectomy and hysterectomy were randomized into a 52-week, multicenter, multinational study that included a 24-week, double-blind (DB), parallel-group, placebo-controlled period followed by a 28-week open-label (OL) period. Patients were stratified based on their use of oral or transdermal ET and randomized to receive placebo or testosterone transdermal system. Patients had to maintain a stable dose of estrogen throughout the study. Upon completion of the DB period, patients receiving placebo were switched to TTS, while the active cohort remained on active treatment. All patients were then followed for an additional 28 weeks for safety. Patients who completed the first 52 weeks of the study were given the opportunity to participate in an open label extension (Years 2, 3 , and 4), which was added to the protocol by amendment. Safety was assessed by adverse events, lipids, serum chemistry with hepatic, renal and carbohydrate metabolism evaluation, coagulation testing, and hematology. Physical exam including clinical assessments of facial hair and acne were monitored.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hypoactive Sexual Desire Disorder
  • Drug: Testosterone Transdermal System
    testosterone patch, 300mcg/day, changed every 3-4 days for up to 52 weeks
  • Drug: Placebo
    placebo patch,changed every 3-4 days for 24 weeks during double blind phase
  • Placebo Comparator: Placebo
    Placebo patch
    Intervention: Drug: Placebo
  • Experimental: Testosterone Patch
    Intervention: Drug: Testosterone Transdermal System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
562
July 2006
December 2003   (final data collection date for primary outcome measure)

Inclusion Criteria:

Eligible women must:

  1. Be 20-70 years old and in generally good health
  2. Have undergone hysterectomy and removal of both ovaries at least 6 months prior to screening
  3. Be receiving a stable dose of estrogen replacement therapy for at least 3 months prior to screening with the intention of maintaining that regimen.
  4. Be, in her own judgment, in a stable monogamous sexual relationship that is perceived to be secure and communicative, for at least one year prior to study entry.
  5. Meet the criteria for having hypoactive sexual desire disorder.

Exclusion Criteria:

Eligible women must not:

  1. Have received androgen therapy at any time during the past 3 months (during the past 7 months if therapy was an investigational implantable product)
  2. Be experiencing any chronic or acute life stress relating to any major life change
  3. Be experiencing depression and/or receiving medication for such illness or disorder
  4. Have current severe skin problems (such as severe or cystic acne) or allergy to adhesives (like the ones in bandages)
  5. Have had a major illness, active gall bladder disease, or gynecological or breast surgery within the last 6 months
  6. Have a history of breast, endometrial, or other gynecological cancer any time before study participation or other cancer within the last 5 years
  7. Have diabetes, a history of cerebrovascular disease, thromboembolic disorders, heart attack, or angina at any time before study participation or thrombophlebitis within the last 5 years
  8. Have abnormal laboratory test results upon initial screening for this study
  9. Have previously participated in P&GP study 1999068 or 1999092
  10. Have previously participated in a clinical trial within 30 days or received an investigation medication within 30 days.
Female
20 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada
 
NCT00331123
2001133 and Yr 2-4 OL
No
Warner Chilcott
Warner Chilcott
Not Provided
Study Director: Johna Lucus, MD Procter and Gamble
Warner Chilcott
April 2013

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