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| Sponsor: | Warner Chilcott |
|---|---|
| Information provided by: | Warner Chilcott |
| ClinicalTrials.gov Identifier: | NCT00384046 |
Purpose
The purpose of this study is to examine whether the transdermal testosterone system (TTS) is effective and safe in the treatment of hypoactive sexual desire disorder (HSDD) in postmenopausal women who are on transdermal estrogen.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypoactive Sexual Desire Disorder |
Drug: Testosterone Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | 24-Week Study to Evaluate the Efficacy/Safety of Transdermal Testosterone in Naturally Menopausal Women With Hypoactive Sexual Desire Disorder Receiving Systemic Transdermal Estrogen Therapy. |
| Enrollment: | 272 |
| Study Start Date: | November 2006 |
| Study Completion Date: | July 2007 |
| Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
300mcg/day testosterone
|
Drug: Testosterone
patch, 300 mcg/day testosterone, patch changed every 3-4 days, 24 weeks
|
|
Placebo Comparator: 2
Placebo arm
|
Drug: Placebo
patch, placebo, patch changed every 3-4 days, 24 weeks
|
This is a randomised, double-blind, placebo-controlled, parallel-group, multicentre, 24 week study to be conducted in approximately 300 patients at approximately 14 clinical sites in the UK, 6 sites in Australia, 5 sites in Germany, and 2 sites in Canada. Women will be randomised 1:1 to receive 300 mcg/day TTS or placebo for a 24 week period. Consistent with previous phase III studies, efficacy will be assessed over 24 weeks using the Sexual Activity Log (SAL), and at 12 and 24 weeks using the Profile of Female Sexual Function (PFSF) and Personal Distress Scale (PDS). Safety will be assessed over the entire 24 weeks. Hormone data (free and total testosterone, total estradiol, and sex hormone binding globulin) will be collected at Weeks -4 and 24. The total duration of treatment for each patient is 24 weeks.
Eligibility| Ages Eligible for Study: | 40 Years to 70 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Australia, New South Wales | |
| Research Facility | |
| Ashfield, New South Wales, Australia, 2131 | |
| Research Facility | |
| Gordon, New South Wales, Australia, 2072 | |
| Research Facility | |
| Randwick, New South Wales, Australia, 2031 | |
| Australia, South Australia | |
| Research Facility | |
| Dulwich, South Australia, Australia, 5065 | |
| Australia, Victoria | |
| Research Facility | |
| Prahran, Victoria, Australia, 3181 | |
| Australia, Western Australia | |
| Research Facility | |
| Nedlands, Western Australia, Australia, 6009 | |
| Botswana | |
| Research Facility | |
| Freiburg, DEU, Botswana, D-79085 | |
| Canada, Quebec | |
| Research Facility | |
| Montréal, Quebec, Canada, H1T 1P6 | |
| Research Facility | |
| Quebec City, Quebec, Canada, G1S 2L6 | |
| Germany | |
| Research Facility | |
| Aachen, Germany, D-52074 | |
| Research Facility | |
| Hamburg, Germany, 20357 | |
| Research Facility | |
| Münster, Germany, 48149 | |
| United Kingdom | |
| Site Facility | |
| Headington, Oxford, United Kingdom, OX3 9DU | |
| Research Facility | |
| Solihull, West Midlands, United Kingdom, B91 2JL | |
| Research Facility | |
| Atherstone, United Kingdom, CV9 1EU | |
| Research Facility | |
| Coventry, United Kingdom, CV7 8LA | |
| Research Facility | |
| Doncaster, United Kingdom, DN1 2ET | |
| Research Facility | |
| Headington, United Kingdom, OX3 9DU | |
| Research Facility | |
| Herts, United Kingdom, SG6 4TS | |
| Research Facility | |
| Leicester, United Kingdom, LE1 5WW | |
| Research Facility | |
| Leicester, United Kingdom, LW1 5WW | |
| Research Facility | |
| Lichfield, United Kingdom, WS14 9LH | |
| Research Facility | |
| London, United Kingdom, SW1W 8RH | |
| Research Facility | |
| London, United Kingdom, W2 1NY | |
| Research Facility | |
| London, United Kingdom, NW8 9NH | |
| Research Facility | |
| London, United Kingdom, W1G 7JW | |
| Research Facility | |
| London, United Kingdom, W12 0HS | |
| Research Facility | |
| London, United Kingdom, SE1 9RT | |
| Research Facility | |
| Plymouth, United Kingdom, PL4 8QU | |
| Research Facility | |
| Salford, United Kingdom, M8 8HD | |
| Research Facility | |
| Warks, United Kingdom, CV9 1EU | |
| Study Director: | Imran A Lodhi, MD | Procter and Gamble |
More Information
| Responsible Party: | Imron Lodhi, MD, Procter and Gamble Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00384046 History of Changes |
| Other Study ID Numbers: | 2005108 |
| Study First Received: | October 3, 2006 |
| Last Updated: | March 22, 2010 |
| Health Authority: | Canada: Health Canada; United States: Food and Drug Administration |
|
Sexual Dysfunctions, Psychological Hypokinesia Sexual and Gender Disorders Mental Disorders Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms Testosterone Testosterone enanthate Testosterone undecanoate Testosterone 17 beta-cypionate |
Methyltestosterone Estrogens Androgens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Anabolic Agents |