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

NCT ID: NCT00384046

Last Updated: 2013-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

272 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2007-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hypoactive Sexual Desire Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

300mcg/day testosterone

Group Type EXPERIMENTAL

Testosterone

Intervention Type DRUG

patch, 300 mcg/day testosterone, patch changed every 3-4 days, 24 weeks

2

Placebo arm

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

patch, placebo, patch changed every 3-4 days, 24 weeks

Interventions

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Testosterone

patch, 300 mcg/day testosterone, patch changed every 3-4 days, 24 weeks

Intervention Type DRUG

Placebo

patch, placebo, patch changed every 3-4 days, 24 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Warner Chilcott

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Imran A Lodhi, MD

Role: STUDY_DIRECTOR

Procter and Gamble

Locations

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Research Facility

Ashfield, New South Wales, Australia

Site Status

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Gordon, New South Wales, Australia

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Randwick, New South Wales, Australia

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Dulwich, South Australia, Australia

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Prahran, Victoria, Australia

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Nedlands, Western Australia, Australia

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Freiburg, DEU, Botswana

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Münster, Münster, Germany

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Aachen, , Germany

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Hamburg, , Germany

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Headington, Oxford, United Kingdom

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Solihull, West Midlands, United Kingdom

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Atherstone, , United Kingdom

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Coventry, , United Kingdom

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Doncaster, , United Kingdom

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Headington, , United Kingdom

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Herts, , United Kingdom

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Leicester, , United Kingdom

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Leicester, , United Kingdom

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Lichfield, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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Plymouth, , United Kingdom

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Salford, , United Kingdom

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Warks, , United Kingdom

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Countries

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Australia Botswana Canada Germany United Kingdom

Other Identifiers

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2005108

Identifier Type: -

Identifier Source: org_study_id

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