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
  Purpose

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.


Condition Intervention Phase
Hypoactive Sexual Desire Disorder
Drug: Testosterone Transdermal System
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Warner Chilcott:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 562
Study Start Date: May 2002
Study Completion Date: July 2006
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo patch
Drug: Placebo
placebo patch,changed every 3-4 days for 24 weeks during double blind phase
Experimental: Testosterone Patch Drug: Testosterone Transdermal System
testosterone patch, 300mcg/day, changed every 3-4 days for up to 52 weeks

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00331123

Locations
United States, Missouri
Research Site
Kansas City, Missouri, United States
Australia, Victoria
Research Site
Prahran, Victoria, Australia
Canada
Research Site
Quebec, Canada
Sponsors and Collaborators
Warner Chilcott
Investigators
Study Director: Johna Lucus, MD Procter and Gamble
  More Information

No publications provided

Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT00331123     History of Changes
Other Study ID Numbers: 2001133 and Yr 2-4 OL
Study First Received: May 26, 2006
Last Updated: April 15, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Warner Chilcott:
Surgical menopause
HSDD

Additional relevant MeSH terms:
Disease
Hypokinesia
Sexual Dysfunctions, Psychological
Pathologic Processes
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Sexual and Gender Disorders
Mental Disorders
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on September 22, 2014