Study of Transdermal Testosterone Patches in Surgically Menopausal Women With Low Libido
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ClinicalTrials.gov Identifier: NCT00331214 |
Recruitment Status :
Completed
First Posted : May 29, 2006
Last Update Posted : April 17, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypoactive Sexual Desire Disorder | Drug: Testosterone Transdermal System Drug: placebo patch | Phase 3 |
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 |

Arm | Intervention/treatment |
---|---|
Sham Comparator: Placebo
placebo patch for 6 months
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Drug: placebo patch
placebo patch replaced every 3-4 days for 6 months |
Experimental: Testosterone
Testosterone patch
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Drug: Testosterone Transdermal System
testosterone patch (300 mcg/day), patch changed twice a week for six months |
- 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 ]
- 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 ]

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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:
- Be 20-70 years old and in generally good health
- Have undergone hysterectomy and removal of both ovaries at least 6 months prior to screening
- Be receiving a stable dose of estrogen replacement therapy for at least 3 months prior to screening with the intention of maintaining that regimen.
- 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.
- Meet the criteria for having hypoactive sexual desire disorder.
Exclusion Criteria:
Eligible women must not:
- Have received androgen therapy at any time during the past 3 months (during the past 7 months if therapy was an investigational implantable product)
- Be experiencing any chronic or acute life stress relating to any major life change
- Be experiencing depression and/or receiving medication for such illness or disorder
- Have current severe skin problems (such as severe or cystic acne) or allergy to adhesives (like the ones in bandages)
- Have had a major illness, active gall bladder disease, or gynecological or breast surgery within the last 6 months
- Have a history of breast, endometrial, or other gynecological cancer at any time before study participation or other cancer within the last 5 years
- 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
- Have abnormal laboratory test results upon initial screening for this study
- Have previously participated in P&GP study 1999068 or 1999092
- Have previously participated in a clinical trial within 30 days or received an investigation medication within 30 days.

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 ClinicalTrials.gov identifier (NCT number): NCT00331214
United States, Colorado | |
Research Site | |
Denver, Colorado, United States | |
Australia, Queensland | |
Research Site | |
Nedlands, Queensland, Australia | |
Canada, Ontario | |
Research Site | |
Kingston, Ontario, Canada |
Study Director: | Johna Lucas, MD | Procter and Gamble |
Responsible Party: | Warner Chilcott |
ClinicalTrials.gov 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 |
Surgical menopause HSDD |
Hypokinesia Sexual Dysfunctions, Psychological Dyskinesias Neurologic Manifestations Nervous System Diseases Mental Disorders |
Testosterone Androgens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |