Female Sexual DysfunctionPhase 2NCT00479570
Study To Investigate Effect Of A New Drug (PF-00446687) In Post-Menopausal Women Who Suffer From Sexual Dysfunction.
A Phase 2 study testing PF-00446687 in people with Female Sexual Dysfunction, run by Pfizer at 3 sites in 3 countries.
Trial summary
The purpose of this study is to investigate the effect of up to 200 mg of PF-00446687 on acute sexual arousal and sexual interest in post menopausal females, as well as examining the safety and toleration of the drug. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Female Sexual Dysfunction
- What is being tested?
- PF-00446687
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Jun 2007to Feb 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 45 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women who have evidence of Female Sexual Arousal Disorder.
- Women who experience personal distress due to Female Sexual Dysfunction.
- Post menopausal women aged between 45 and 65 years.
Who cannot join
- Women whose sexual dysfunction is limited to certain types of stimulation, situation or specific partners.
- Women who experience pain with sexual intercourse or who have a sexual aversion disorder.
- Women suffering from female sexual dysfunction where the cause is treatable, for example inadequately controlled diabetes or thyroid dysfunction.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Phase 2A Multi-Centre, Double Blind, Placebo Controlled 3-Way Cross-Over Study To Investigate The Effect Of Single Doses Of PF-00446687 On Sexual Arousal And Sexual Desire In Women Suffering From Female Sexual Dysfunction (FSD).
The purpose of this study is to investigate the effect of up to 200 mg of PF-00446687 on acute sexual arousal and sexual interest in post menopausal females, as well as examining the safety and toleration of the drug.
- Conditions
- Female Sexual Dysfunction
- Being tested
- PF-00446687, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-00446687Drug
Single 200mg dose
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Study period 1, 2 or 3 | Experimental | Not described Receives: Drug: PF-00446687 |
| Placebo Study period 1, 2 or 3 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess effect of single doses of PF-00446687 on acute sexual arousal and sexual interest, using questionnaires, in post menopausal women suffering from Female Sexual Dysfunction. A diary will be completed for 7 days following the 3 dosing days.
Measured: From day of dosing until 7 days post-dose
Secondary outcomes (4)
Assess effect of single doses on medium term (1 week) sexual arousal and interest.
Measured: Until 7 days post-dose
Assess variability of response and repeatability of design between 2 similar doses.
Measured: Comparison of response to be assessed until 7 days post dose
If possible assess the effect of PF-00446687 on vaginal blood flow on day 1 of each study period.
Measured: Day of dosing
Assess PK , safety and toleration on day 1 of each study period.
Measured: Day of dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2007 (estimated)
- Study startJun 2007
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Sexual DysfunctionStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 participants (actual)
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
- NCT00479570
- Sponsor's protocol ID
- A8361015
- Status last verified
- Jan 2019
- First submitted
- 24 May 2007
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2A Multi-Centre, Double Blind, Placebo Controlled 3-Way Cross-Over Study To Investigate The Effect Of Single Doses Of PF-00446687 On Sexual Arousal And Sexual Desire In Women Suffering From Female Sexual Dysfunction (FSD).
- ClinicalTrials.gov ID
- NCT00479570
- Acronym / sponsor ID
- A8361015
- Conditions
- Female Sexual Dysfunction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 28 May 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.
The purpose of this study is to investigate the effect of up to 200 mg of PF-00446687 on acute sexual arousal and sexual interest in post menopausal females, as well as examining the safety and toleration of the drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study period 1, 2 or 3 | Experimental | Drug: PF-00446687 |
| Placebo Study period 1, 2 or 3 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women who have evidence of Female Sexual Arousal Disorder.
- Women who experience personal distress due to Female Sexual Dysfunction.
- Post menopausal women aged between 45 and 65 years.
Key exclusion criteria (3 listed)
- Women whose sexual dysfunction is limited to certain types of stimulation, situation or specific partners.
- Women who experience pain with sexual intercourse or who have a sexual aversion disorder.
- Women suffering from female sexual dysfunction where the cause is treatable, for example inadequately controlled diabetes or thyroid dysfunction.
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 |
|---|---|---|
| PF-00446687Single 200mg dose | Drug | Study period 1, 2 or 3 |
| Placebo | Drug | Placebo Study period 1, 2 or 3 |
Primary outcome
Assess effect of single doses of PF-00446687 on acute sexual arousal and sexual interest, using questionnaires, in post menopausal women suffering from Female Sexual Dysfunction. A diary will be completed for 7 days following the 3 dosing days.
Time frame: From day of dosing until 7 days post-dose
4 secondary outcomes
Assess effect of single doses on medium term (1 week) sexual arousal and interest.
Time frame: Until 7 days post-dose
Assess variability of response and repeatability of design between 2 similar doses.
Time frame: Comparison of response to be assessed until 7 days post dose
If possible assess the effect of PF-00446687 on vaginal blood flow on day 1 of each study period.
Time frame: Day of dosing
Assess PK , safety and toleration on day 1 of each study period.
Time frame: Day of dosing
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 31 Jan 2019.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Female Sexual Dysfunction
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Recruiting
PRP for Sexual Function
Female Sexual Dysfunction, Sexual Dysfunction
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
RecruitingObservational study
Rigid Hymenal Ring as a Cause for Insertional Dyspareunia
Dyspareunia (Female)
RecruitingObservational study
Gonadal Tissue Freezing for Fertility Preservation in Individuals at Risk for Ovarian Dysfunction, Premature Ovarian Insufficiency and Clinically Indicated Gonadectomy
Turner Syndrome, Post-menarcheal Adolescents
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
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PF-00446687 in people with Female Sexual Dysfunction, run by Pfizer at 3 sites in 3 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 31 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark, Norway, Sweden. 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?
Assess effect of single doses of PF-00446687 on acute sexual arousal and sexual interest, using questionnaires, in post menopausal women suffering from Female Sexual Dysfunction. A diary will be completed for 7 days following the 3 dosing days. (time frame: From day of dosing until 7 days post-dose). 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 31 Jan 2019.