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Trial registered on ANZCTR


Registration number
ACTRN12605000481673
Ethics application status
Approved
Date submitted
12/09/2005
Date registered
23/09/2005
Date last updated
25/06/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
A double-blind randomised placebo controlled study to evaluate the effects of different doses of testosterone from a Testosterone Metered-Dose Transdermal Spray (MDTS) on sexual function in premenopausal women with low libido
Scientific title
A double-blind randomised placebo controlled study to evaluate the effects of different doses of testosterone from a Testosterone Metered-Dose Transdermal Spray (MDTS) on sexual function in premenopausal women with low libido
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low libido in post menopausal women suffering from low serum testosterone 602 0
Condition category
Condition code
Reproductive Health and Childbirth 675 675 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Testosterone Metered-Dose Transdermal Spray (MDTS) for 16 weeks.
Comparator / control treatment
Control group
Placebo

Outcomes
Primary outcome [1] 815 0
Frequency of satisfactory sexual events compared to placebo after 16 weeks
Timepoint [1] 815 0
After 16 weeks
Secondary outcome [1] 1627 0
Frequency of satisfactory and total sexual events at other timepoints throughout the study.
Timepoint [1] 1627 0

Eligibility
Key inclusion criteria
Postmenopausal women suffering from low libido with low serum testosterone who are otherwise healthy.
Minimum age
18 Years
Maximum age
Not stated
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

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)
Numbered containers with blinded medication number, blind held in separately sealed envelopes which could be broken in case of SAE
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated in blocks
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 746 0
Commercial sector/Industry
Name [1] 746 0
FemPharm Pty Ltd
Address [1] 746 0
Country [1] 746 0
Australia
Funding source category [2] 747 0
Commercial sector/Industry
Name [2] 747 0
Acrux DDS Pty Ltd
Address [2] 747 0
Country [2] 747 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
FemPharm Pty Ltd and/or Acrux DDS Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 618 0
None
Name [1] 618 0
None
Address [1] 618 0
Country [1] 618 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35508 0
Address 35508 0
Country 35508 0
Phone 35508 0
Fax 35508 0
Email 35508 0
Contact person for public queries
Name 9700 0
Karen Gard'ner
Address 9700 0
Acrux Drug Delivery Solutions (DDS) Pty Ltd
103-113 Stanley Street
West Melbourne VIC 3003
Country 9700 0
Australia
Phone 9700 0
+61 3 83790100
Fax 9700 0
Email 9700 0
karen.gardner@acrux.com.au
Contact person for scientific queries
Name 628 0
Andrew Humberstone
Address 628 0
Acrux Drug Delivery Solutions (DDS) Pty Ltd
103-113 Stanley Street
West Melbourne VIC 3003
Country 628 0
Australia
Phone 628 0
+61 3 83790100
Fax 628 0
Email 628 0
andrew.humberstone@acrux.com.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary