| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Female Sexual Dysfunction (FSD). |
|
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 9.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10062641 |
| E.1.2 | Term | Female sexual arousal disorder |
|
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
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). |
|
| E.2.2 | Secondary objectives of the trial |
*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. |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal 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. |
|
| E.4 | Principal 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 have recorded less than 4 sexual events over the 4 week run-in period.
3. With any clinically significant abnormality following review of pre-trial laboratory data (particular attention should be paid to transaminases and bilirubin which must not exceed 1.2x upper limit of normal) and full physical and gynaecological examination.
4. Who do not meet the criteria for cognitive FSAD based on the cut score for the ASFQ after the placebo run-in period. |
|
| E.5 End points |
| E.5.1 | 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
|
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | Yes |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | Yes |
| E.6.13.1 | Other scope of the trial description |
|
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | Information not present in EudraCT |
| E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
| E.7.1.3 | Other | Information not present in EudraCT |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | Yes |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | Yes |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | Yes |
| E.8.2.3 | Other | No |
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 7 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
| E.8.7 | Trial has a data monitoring committee | No |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
| End of Trial in a Member State of the European Union is defined as the time at which it is deemed that sufficient subjects have been recruited and completed the trial as stated in the regulatory application (i.e., Clinical Trial Application (CTA)) and ethics application in the Member State. Poor recruitment (recruiting less than the anticipated number in the CTA) by a Member State is not a reason for premature termination but is considered a normal conclusion to the trial in that Member State. |
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 1 |
| E.8.9.1 | In the Member State concerned months | 0 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 1 |
| E.8.9.2 | In all countries concerned by the trial months | 0 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
Print
