Trial Review

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00482664




Registration number
NCT00482664
Ethics application status
Date submitted
1/06/2007
Date registered
5/06/2007
Date last updated
1/11/2010

Titles & IDs
Public title
The Efficacy, Safety And Toleration Of CP-866,087 In Pre-Menopausal Women With Female Sexual Arousal Disorder.
Scientific title
A Phase 2a Multi-Centre, Double Blind, Placebo Controlled Cross-Over Trial To Investigate The Efficacy, Safety And Toleration Of CP-866,087 In Pre-Menopausal Women Diagnosed With Female Sexual Arousal Disorder (FSAD).
Secondary ID [1] 0 0
A5051017
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sexual Dysfunction, Physiological 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Reproductive Health and Childbirth 0 0 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CP-866,087
Treatment: Drugs - CP-866,087
Treatment: Drugs - CP-866,087
Treatment: Drugs - Placebo

Experimental: 1 mg -

Experimental: 10 mg -

Experimental: 3 mg -

Placebo Comparator: Placebo -


Treatment: Drugs: CP-866,087
Tablets for oral administration

Treatment: Drugs: CP-866,087
Tablets for oral administration

Treatment: Drugs: CP-866,087
Tablets for oral administration

Treatment: Drugs: Placebo
Tablets for oral administration
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Diary events, including Satisfactory Sexual Experiences (SSEs) over 6 weeks.
Timepoint [1] 0 0
6 weeks
Primary outcome [2] 0 0
Score in Abbreviated Sexual Function Questionnaire after 6 weeks of treatment.
Timepoint [2] 0 0
6 weeks
Secondary outcome [1] 0 0
Exit interview at end of study. Meaningful Benefit Question at end of study.
Timepoint [1] 0 0
End of study
Secondary outcome [2] 0 0
Measure of Female Sexual Distress questionnaire after 6 weeks of treatment.
Timepoint [2] 0 0
6 weeks

Eligibility
Key inclusion criteria
- healthy pre-menopausal women

- primary female sexual arousal disorder causing distress

- on stable use of oral contraceptives
Minimum age
20 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- any other significant disease causing Female Sexual Dysfunction including psychiatric
disease

- subjects on drugs known to cause Female Sexual Dysfunction

- subjects who have given birth in the last 12 months or who are planning to become
pregnant during the study

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 administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 2
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
1/07/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2008
Sample size
Target
84
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,WA
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Dulwich
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
5065 - Dulwich
Recruitment postcode(s) [2] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
Denmark
State/province [1] 0 0
Aarhus C
Country [2] 0 0
Denmark
State/province [2] 0 0
Kobenhavn OE
Country [3] 0 0
Denmark
State/province [3] 0 0
Odense C
Country [4] 0 0
Norway
State/province [4] 0 0
Oslo
Country [5] 0 0
South Africa
State/province [5] 0 0
Kwa-Zulu Natal
Country [6] 0 0
South Africa
State/province [6] 0 0
Pretoria
Country [7] 0 0
Sweden
State/province [7] 0 0
Lund
Country [8] 0 0
Sweden
State/province [8] 0 0
Skovde
Country [9] 0 0
Sweden
State/province [9] 0 0
Stockholm

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

Ethics approval
Ethics application status

Summary
Brief summary
CP-866,087 is a non-hormonal compound, acting on the central nervous system, which has been
shown in animal models to restore sexual function.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00482664
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00482664