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Study of Transdermal Testosterone Patches in Surgically 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: NCT00331214
Recruitment Status : Completed
First Posted : May 29, 2006
Last Update Posted : April 17, 2013
Sponsor:
Information provided by (Responsible Party):
Warner Chilcott

Tracking Information
First Submitted Date  ICMJE May 26, 2006
First Posted Date  ICMJE May 29, 2006
Last Update Posted Date April 17, 2013
Study Start Date  ICMJE June 2002
Actual Primary Completion Date December 2003   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2008)
To assess the efficacy of testosterone transdermal system (TS) as measured by the change from baseline in the frequency of total satisfying sexual activity captured by the Sexual Activity Log (SAL). [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 26, 2006)
To assess the efficacy of testosterone transdermal system (TS) as measured by the change from baseline in the frequency of total saatisfying sexual activity captured by the Sexual Activity Log (SAL).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2008)
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: 6 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 26, 2006)
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.
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 Surgically Menopausal Women With Low Libido
Official Title  ICMJE Study to Evaluate the Efficacy and Safety of Transdermal Testosterone in Women With Hypoactive Sexual Desire Disorder on Concurrent Estrogen Replacement Therapy and Undergone Hysterectomy/Bilateral Oophorectomy
Brief Summary 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.
Detailed Description Women with hypoactive sexual desire disorder (HSDD) who had undergone bilateral salpingo-oophorectomy and hysterectomy were randomized into a 24-week, multicenter, multinational, double-blind (DB), parallel-group, placebo-controlled study. 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. Patients who completed the first 24 weeks of the study were given the opportunity to participate in a 3.5 year open-label (active treatment) study extension which was added to the protocol by amendment. Safety was assessed by adverse events, lipids, serum chemistry with hepatic, renal and carbohydrate metabolism evaluation, and hematology. Physical exam including clinical assessments of facial hair and acne were monitored.
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 System
    testosterone patch (300 mcg/day), patch changed twice a week for six months
  • Drug: placebo patch
    placebo patch replaced every 3-4 days for 6 months
Study Arms  ICMJE
  • Sham Comparator: Placebo
    placebo patch for 6 months
    Intervention: Drug: placebo patch
  • Experimental: Testosterone
    Testosterone patch
    Intervention: Drug: Testosterone Transdermal System
Publications * Not Provided

*   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)
533
Original Enrollment  ICMJE
 (submitted: May 26, 2006)
500
Actual Study Completion Date  ICMJE July 2006
Actual Primary Completion Date December 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 at 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.
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,   Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00331214
Other Study ID Numbers  ICMJE 2001134 and Yr 2-4 OL
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
Study Director: Johna Lucas, MD Procter and Gamble
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