Female Sexual Dysfunction (FSD). MedDRA version: 9.1 Level: LLT Classification code 10062641 Term: Female sexual arousal disorder
Conditions
Interventions
Product Code: CP-866,087
Pharmaceutical Form: Tablet
CAS Number: 519052-03-0
Current Sponsor code: CP-866,087
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
P
Sponsors
Pfizer Ltd, Ramsgate Road, Sandwich, Kent. UK
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion and exclusion criteria to be eligible for enrollment into the trial: 1. Be able to understand and personally sign and date the informed consent documentation, indicating that the subject has been informed of all pertinent aspects of the trial. 2. Be a pre-menopausal female, between 20 and 45 years inclusive in good general health. 3. Have had symptoms of FSAD for at least 6 months and for no more than 5 years prior to trial entry. 4. Be diagnosed by an experienced FSD therapist/clinician to have FSAD. 5. Have evidence of cognitive female sexual arousal disorder as determined by the ASFQ. The subject will be included if the Arousal-Cognition score is within the appropriate range as outlined in the scoring guidance. 6. Experience personal distress due to FSD as assessed by the MFSD. The subject will be included if the score is within the appropriate range as outlined in the scoring guidance. 7. Have been in a committed and positive heterosexual relationship for at least 6 months at the time of enrolment. 8. Be committed to attempt sexual activity at least twice a week. 9. Be willing and able to comply with scheduled visits, laboratory tests and other trial procedures. 10. Have had stable use of chosen combined oral contraceptive for a minimum of 6 months prior to trial entry, and FSD must not be linked to contraceptive use. 11. Continue the same oral contraceptive birth control for the duration of the trial and followup period, and be non-lactating, with a negative urine pregnancy test. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects: 1. Who are known to be peri- or post-menopausal, as defined by a documented history of: • Bilateral functional oophorectomy or • History of natural amenorrhoea for >3 months prior to use of oral contraceptives. 2. Who have any other significant sexual disorder (e.g. dyspareunia, vaginismus, gender identity disorder, paraphilia) apart from hypoactive sexual desire disorder or orgasm disorder. 3. Who currently participate in a structured psychosexual therapy program. 4. Whose sexual dysfunction is considered to be situational, i.e. limited to certain types of stimulation, situation or specific partners. 5. Who have received treatment for any major psychiatric disorder (e.g. psychosis or hospitalization due to major depression) within the past 12 months. 6. Who have taken SSRIs (selective serotonin re-uptake inhibitors), SNRIs (selective noradrenalin re-uptake inhibitors), tricyclic antidepressants, bupropion, beta-blockers, alpha-adrenergic blockers, Class I and III antiarrhythmic drugs, testosterone and antiandrogens within the last month. 7. Subjects who are taking concomitant medications which could potentially decrease the effectiveness of the oral contraceptives, including enzyme inducers (such as griseofulvin, modafinil, nelfinavir, nevirapine, oxcarbazepine, phenytoin, phenobarbital, primidone, ritonavir, St John's Wort, topiramate, and, above all, rifabutin and rifampicin) and antibiotics that alter gut flora (such as ampillicin or doxycycline). 8. With otherwise treatable causes of FSAD including inadequately controlled diabetes, thyroid dysfunction or clinically significant hyperprolactinemia. 9. With presence of organic condition known to cause sexual dysfunction (multiple sclerosis, spinal cord injury). 10. Whose partner has unresolved sexual dysfunction (e.g. erectile dysfunction, ejaculatory dysfunction, desire disorder). 11. Who have given birth in the previous 12 months. 12. Who have undergone major surgery in the past 12 months. 13. Who are currently on treatment for sexually transmitted disease. 14. With any other major psychological or sexual disorder, not otherwise listed in the exclusion criteria, which is considered to be the primary diagnosis explaining the sexual dysfunction. 15. With a family history of prolonged QT syndrome or who themselves have a QTc of >450 msec or any other clinically significant abnormality recorded in a 12-lead supine ECG at the screening visit. 16. With a recent (past 6 months) history of alcohol or controlled substance abuse. 17. With a history of anorexia or bulimia in the last 5 years. 18. With a past history of hepatic impairment, gallbladder disease or Gilbert’s syndrome. 19. Who have been participating in another experimental trial within the last 30 days. 20. Who, in the opinion of the investigator have any medical or psychological condition or social circumstances which would impair their ability to participate reliably in the trial, or who may increase the risk to themselves or others by participating. 21. Who, in the opinion of the investigator, are not likely to complete the trial for whatever reason (e.g. planned surgery). 22. Who are known to be sensitive to sulphonamide antibiotics or any of the specific excipients used in the formulation of tablets. Additional Exclusion Criteria after placebo run-in period Subjects: 1. Who have taken less than 75% of their required trial medication during the run-in period. 2. Who have completed less than 90 % of their diary or h
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: *Estimate the effect of CP-866,087 1, 3 and 10 mg vs. placebo on Satisfactory Sexual Events (SSEs) in pre-menopausal women on oral contraceptives suffering primarily from FSAD. *Develop a dose-response relationship for CP-866,087. *Assess the safety and toleration of CP-866,087.;Main Objective: Assess the effect of 3 doses (1, 3 and 10 mg) of CP-866,087 vs. placebo on female arousal, desire, orgasm and distress in pre-menopausal women on oral contraceptives suffering primarily from Female Sexual Arousal Disorder (FSAD).;Primary end point(s): There is no primary endpoint for this study. However, most interest will be in the three Arousal Domains of the ASFQ (sensation, lubrication and cognitive). The following efficacy end points are conducted: • Abbreviated Sexual Function Questionnaire (ASFQ) Arousal (Lubrication/Sensation/Cognition), Desire and Orgasm domains • Measure of Female Sexual Distress (MFSD) • Diary, including Satisfactory Sexual Experiences (SSEs) • Exit interview • Meaningful Benefit Question (MBQ) • Pharmacodynamic serum hormone assessment • Pharmacokinetic analysis of CP-866,087 Safety End Point: • Adverse events • Laboratory safety data • Physical examination • Urine Pregnancy Test • ECG | — |
Countries
Denmark, Sweden
Outcome results
None listed