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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. Identifier: NCT00331214
Recruitment Status : Completed
First Posted : May 29, 2006
Last Update Posted : April 17, 2013
Information provided by (Responsible Party):
Warner Chilcott

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.

Condition or disease Intervention/treatment Phase
Hypoactive Sexual Desire Disorder Drug: Testosterone Transdermal System Drug: placebo patch Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 533 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2002
Actual Primary Completion Date : December 2003
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause

Arm Intervention/treatment
Sham Comparator: Placebo
placebo patch for 6 months
Drug: placebo patch
placebo patch replaced every 3-4 days for 6 months

Experimental: Testosterone
Testosterone patch
Drug: Testosterone Transdermal System
testosterone patch (300 mcg/day), patch changed twice a week for six months

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00331214

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United States, Colorado
Research Site
Denver, Colorado, United States
Australia, Queensland
Research Site
Nedlands, Queensland, Australia
Canada, Ontario
Research Site
Kingston, Ontario, Canada
Sponsors and Collaborators
Warner Chilcott
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Study Director: Johna Lucas, MD Procter and Gamble
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Responsible Party: Warner Chilcott Identifier: NCT00331214    
Other Study ID Numbers: 2001134 and Yr 2-4 OL
First Posted: May 29, 2006    Key Record Dates
Last Update Posted: April 17, 2013
Last Verified: April 2013
Keywords provided by Warner Chilcott:
Surgical menopause
Additional relevant MeSH terms:
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Sexual Dysfunctions, Psychological
Neurologic Manifestations
Nervous System Diseases
Mental Disorders
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs