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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00384046




Registration number
NCT00384046
Ethics application status
Date submitted
3/10/2006
Date registered
4/10/2006
Date last updated
17/04/2013

Titles & IDs
Public title
Testosterone Therapy in Naturally Menopausal Women With Low Sexual Desire Receiving Transdermal Estrogen
Scientific 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.
Secondary ID [1] 0 0
2005108
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypoactive Sexual Desire Disorder 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Testosterone
Treatment: Drugs - Placebo

Experimental: 1 - 300mcg/day testosterone

Placebo Comparator: 2 - Placebo arm


Treatment: Drugs: Testosterone
patch, 300 mcg/day testosterone, patch changed every 3-4 days, 24 weeks

Treatment: Drugs: Placebo
patch, placebo, patch changed every 3-4 days, 24 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To assess the efficacy of the TTS by measuring change in frequency of total satisfying episodes. The safety assessment of TTS with various parameters.
Timepoint [1] 0 0
Assessment at 12 and 24 weeks
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Assessment at 12 and 24 weeks

Eligibility
Key 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.
Minimum age
40 Years
Maximum age
70 Years
Sex
Females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2007
Sample size
Target
Accrual to date
Final
272
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Research Facility - Ashfield
Recruitment hospital [2] 0 0
Research Facility - Gordon
Recruitment hospital [3] 0 0
Research Facility - Randwick
Recruitment hospital [4] 0 0
Research Facility - Dulwich
Recruitment hospital [5] 0 0
Research Facility - Prahran
Recruitment hospital [6] 0 0
Research Facility - Nedlands
Recruitment postcode(s) [1] 0 0
2131 - Ashfield
Recruitment postcode(s) [2] 0 0
2072 - Gordon
Recruitment postcode(s) [3] 0 0
2031 - Randwick
Recruitment postcode(s) [4] 0 0
5065 - Dulwich
Recruitment postcode(s) [5] 0 0
3181 - Prahran
Recruitment postcode(s) [6] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
Botswana
State/province [1] 0 0
DEU
Country [2] 0 0
Canada
State/province [2] 0 0
Quebec
Country [3] 0 0
Germany
State/province [3] 0 0
Aachen
Country [4] 0 0
Germany
State/province [4] 0 0
Hamburg
Country [5] 0 0
Germany
State/province [5] 0 0
Münster
Country [6] 0 0
United Kingdom
State/province [6] 0 0
Oxford
Country [7] 0 0
United Kingdom
State/province [7] 0 0
West Midlands
Country [8] 0 0
United Kingdom
State/province [8] 0 0
Atherstone
Country [9] 0 0
United Kingdom
State/province [9] 0 0
Coventry
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Doncaster
Country [11] 0 0
United Kingdom
State/province [11] 0 0
Headington
Country [12] 0 0
United Kingdom
State/province [12] 0 0
Herts
Country [13] 0 0
United Kingdom
State/province [13] 0 0
Leicester
Country [14] 0 0
United Kingdom
State/province [14] 0 0
Lichfield
Country [15] 0 0
United Kingdom
State/province [15] 0 0
London
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Plymouth
Country [17] 0 0
United Kingdom
State/province [17] 0 0
Salford
Country [18] 0 0
United Kingdom
State/province [18] 0 0
Warks

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Warner Chilcott
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT00384046
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Imran A Lodhi, MD
Address 0 0
Procter and Gamble
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries