Testosterone Therapy in Naturally Menopausal Women With Low Sexual Desire Receiving Transdermal Estrogen
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.
1 other identifier
interventional
272
5 countries
31
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2006
Shorter than P25 for phase_3
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 3, 2006
CompletedFirst Posted
Study publicly available on registry
October 4, 2006
CompletedStudy Start
First participant enrolled
November 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedApril 17, 2013
April 1, 2013
8 months
October 3, 2006
April 15, 2013
Conditions
Outcome Measures
Primary Outcomes (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.
Assessment at 12 and 24 weeks
Secondary Outcomes (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.
Assessment at 12 and 24 weeks
Study Arms (2)
1
EXPERIMENTAL300mcg/day testosterone
2
PLACEBO COMPARATORPlacebo arm
Interventions
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Warner Chilcottlead
Study Sites (31)
Research Facility
Ashfield, New South Wales, 2131, Australia
Research Facility
Gordon, New South Wales, 2072, Australia
Research Facility
Randwick, New South Wales, 2031, Australia
Research Facility
Dulwich, South Australia, 5065, Australia
Research Facility
Prahran, Victoria, 3181, Australia
Research Facility
Nedlands, Western Australia, 6009, Australia
Research Facility
Freiburg, DEU, D-79085, Botswana
Research Facility
Montreal, Quebec, H1T 1P6, Canada
Research Facility
Québec, Quebec, G1S 2L6, Canada
Research Facility
Münster, Münster, 48149, Germany
Research Facility
Aachen, D-52074, Germany
Research Facility
Hamburg, 20357, Germany
Site Facility
Headington, Oxford, OX3 9DU, United Kingdom
Research Facility
Solihull, West Midlands, B91 2JL, United Kingdom
Research Facility
Atherstone, CV9 1EU, United Kingdom
Research Facility
Coventry, CV7 8LA, United Kingdom
Research Facility
Doncaster, DN1 2ET, United Kingdom
Research Facility
Headington, OX3 9DU, United Kingdom
Research Facility
Herts, SG6 4TS, United Kingdom
Research Facility
Leicester, LE1 5WW, United Kingdom
Research Facility
Leicester, LW1 5WW, United Kingdom
Research Facility
Lichfield, WS14 9LH, United Kingdom
Research Facility
London, NW8 9NH, United Kingdom
Research Facility
London, SE1 9RT, United Kingdom
Research Facility
London, SW1W 8RH, United Kingdom
Research Facility
London, W12 0HS, United Kingdom
Research Facility
London, W1G 7JW, United Kingdom
Research Facility
London, W2 1NY, United Kingdom
Research Facility
Plymouth, PL4 8QU, United Kingdom
Research Facility
Salford, M8 8HD, United Kingdom
Research Facility
Warks, CV9 1EU, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Imran A Lodhi, MD
Procter and Gamble
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2006
First Posted
October 4, 2006
Study Start
November 1, 2006
Primary Completion
July 1, 2007
Study Completion
July 1, 2007
Last Updated
April 17, 2013
Record last verified: 2013-04