Sexual Dysfunction, PhysiologicalPhase 2NCT00482664
The Efficacy, Safety And Toleration Of CP-866,087 In Pre-Menopausal Women With Female Sexual Arousal Disorder.
A Phase 2 study testing CP-866,087 in people with Sexual Dysfunction, Physiological, run by Pfizer at 12 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Sexual Dysfunction, Physiological
- What is being tested?
- CP-866,087
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 12 sitesin 5 countries
- Study dates
- Jul 2007to Oct 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- healthy pre-menopausal women
- primary female sexual arousal disorder causing distress
- on stable use of oral contraceptives
Who cannot join
- 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
Trial locations and contacts
12 sites in 5 countries.
12 sites in 5 countries
Sweden4 sites
Pfizer Investigational Site
Lund, 221 85
Pfizer Investigational Site
Skövde, 541 30
Pfizer Investigational Site
Stockholm, 141 86
Pfizer Investigational Site
Stockholm, S-182 88
Denmark3 sites
Pfizer Investigational Site
Aarhus C, 8000
Pfizer Investigational Site
Kobenhavn OE, 2100
Pfizer Investigational Site
Odense C, 5000
Australia2 sites
Pfizer Investigational Site
Dulwich, South Australia, 5065
Pfizer Investigational Site
Nedlands, Western Australia, 6009
South Africa2 sites
Pfizer Investigational Site
Pretoria, 0132
Pfizer Investigational Site
Westville, KwaZulu-Natal, 3629
About this study
Official 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).
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.
- Conditions
- Sexual Dysfunction, Physiological
- Being tested
- CP-866,087, Placebo
- Medical subject headings
- Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CP-866,087Drug
Tablets for oral administration
CP-866,087Drug
Tablets for oral administration
CP-866,087Drug
Tablets for oral administration
PlaceboDrug
Tablets for oral administration
| Study group | Role | What they receive |
|---|---|---|
| 1 mg | Experimental | Not described Receives: Drug: CP-866,087 |
| 10 mg | Experimental | Not described Receives: Drug: CP-866,087 |
| 3 mg | Experimental | Not described Receives: Drug: CP-866,087 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diary events, including Satisfactory Sexual Experiences (SSEs) over 6 weeks.
Measured: 6 weeks
Score in Abbreviated Sexual Function Questionnaire after 6 weeks of treatment.
Measured: 6 weeks
Secondary outcomes (2)
Exit interview at end of study. Meaningful Benefit Question at end of study.
Measured: End of study
Measure of Female Sexual Distress questionnaire after 6 weeks of treatment.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2007 (estimated)
- Study startJul 2007
- Primary completionSep 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual Dysfunction, PhysiologicalStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00482664
- Sponsor's protocol ID
- A5051017
- Status last verified
- Oct 2010
- First submitted
- 1 Jun 2007
- Last updated
- 1 Nov 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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).
- ClinicalTrials.gov ID
- NCT00482664
- Acronym / sponsor ID
- A5051017
- Conditions
- Sexual Dysfunction, Physiological
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 5 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 mg | Experimental | Drug: CP-866,087 |
| 10 mg | Experimental | Drug: CP-866,087 |
| 3 mg | Experimental | Drug: CP-866,087 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy pre-menopausal women
- primary female sexual arousal disorder causing distress
- on stable use of oral contraceptives
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CP-866,087Tablets for oral administration | Drug | 1 mg |
| CP-866,087Tablets for oral administration | Drug | 10 mg |
| CP-866,087Tablets for oral administration | Drug | 3 mg |
| PlaceboTablets for oral administration | Drug | Placebo |
Primary outcome
Diary events, including Satisfactory Sexual Experiences (SSEs) over 6 weeks.
Time frame: 6 weeks
Score in Abbreviated Sexual Function Questionnaire after 6 weeks of treatment.
Time frame: 6 weeks
2 secondary outcomes
Exit interview at end of study. Meaningful Benefit Question at end of study.
Time frame: End of study
Measure of Female Sexual Distress questionnaire after 6 weeks of treatment.
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2010.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
12 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CP-866,087 in people with Sexual Dysfunction, Physiological, run by Pfizer at 12 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Sweden, Denmark, Australia, South Africa, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diary events, including Satisfactory Sexual Experiences (SSEs) over 6 weeks. (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2010.