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Testosterone Therapy in Naturally Menopausal Women With Low Sexual Desire Receiving Transdermal Estrogen

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: NCT00384046
Recruitment Status : Completed
First Posted : October 4, 2006
Last Update Posted : April 17, 2013
Sponsor:
Information provided by (Responsible Party):
Warner Chilcott

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Hypoactive Sexual Desire Disorder Drug: Testosterone Drug: Placebo Phase 3

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 272 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
Study Start Date : November 2006
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. To assess the efficacy of the TTS by measuring change in frequency of total satisfying episodes. The safety assessment of TTS with various parameters. [ Time Frame: Assessment at 12 and 24 weeks ]

Secondary Outcome Measures :
  1. To assess the efficacy of the TTS as measured by the following parameters: changes in sexual desire, personal distress, and other domains of PFSF and SAL questionnaires. [ Time Frame: Assessment at 12 and 24 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women will be screened for study participation according to the following inclusion criteria at Week -4. Eligible women must be a woman one year post menopausal, 40-70 years old in general good health on transdermal HRT and in a stable monogamous sexual relationship with low sexual desire causing distress.

Exclusion Criteria:

  • Women will be screened for study participation according to the following exclusion criteria at Week -4 or as specified. Eligible women must not have any medical, physical, psychological, or pharmacological condition that could confound safety or efficacy.
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00384046


Locations
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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, NW8 9NH
Research Facility
London, United Kingdom, SE1 9RT
Research Facility
London, United Kingdom, SW1W 8RH
Research Facility
London, United Kingdom, W12 0HS
Research Facility
London, United Kingdom, W1G 7JW
Research Facility
London, United Kingdom, W2 1NY
Research Facility
Plymouth, United Kingdom, PL4 8QU
Research Facility
Salford, United Kingdom, M8 8HD
Research Facility
Warks, United Kingdom, CV9 1EU
Sponsors and Collaborators
Warner Chilcott
Investigators
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Study Director: Imran A Lodhi, MD Procter and Gamble
More Information
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Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT00384046    
Other Study ID Numbers: 2005108
First Posted: October 4, 2006    Key Record Dates
Last Update Posted: April 17, 2013
Last Verified: April 2013
Additional relevant MeSH terms:
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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