PHASE 2A MULTI-CENTRE, DOUBLE BLIND (3RD PARTY OPEN), 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). - n/a

• Register: EUCTR
• Last refreshed on: 22 April 2013
• Main ID: EUCTR2007-001037-34-DK
• Date of registration: 03/07/2007
• Prospective Registration: Yes
• Primary sponsor: Pfizer Limited, Ramsgate Road, Sandwich, Kent. UK. CT13 9NJ
• Public title: PHASE 2A MULTI-CENTRE, DOUBLE BLIND (3RD PARTY OPEN), 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). - n/a
• Scientific title: PHASE 2A MULTI-CENTRE, DOUBLE BLIND (3RD PARTY OPEN), 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). - n/a
• Date of first enrolment: 07/08/2007
• Target sample size: 24
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-001037-34
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: yes Other: yes Other trial design description: 3rd party open If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Denmark, Sweden

Key inclusion & exclusion criteria

Inclusion criteria:
1. Post-menopausal women (with/without systemic Hormone Replacement Therapy (HRT)) aged 45-65 defined by a documented history of
Natural amenorrhoea for > 1 year, OR Bilateral oophorectomy OR
Subjects who are surgically menopausal (hysterectomy).
Subjects who are currently taking systemic (HRT) must have taken this at a stable dose for at least 3 months. This stable dose must be maintained throughout the duration of the study. (The exception is subjects who have already been on systemic HRT and who have switched to a new brand type. They will only need to establish stable use for 1 month). HRT is defined as any estrogenic hormonal medication administered alone or in combination with progesterone/progestogens and/or androgens. Subjects will only be included if the supplement has been prescribed for an approved indication, the delivery route is approved and a reliable assay is available to ensure resultant hormone levels are not supra-physiologic. Specifically testosterone replacement for libido enhancement, methyl-testosterone supplements and testosterone creams are excluded.
2. Subjects must personally sign and date the informed consent documentation indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial.
3. Subjects must have been in a stable heterosexual relationship for at least 6 months prior to study start and must remain in a stable relationship throughout the duration of the study.
4. Subjects must be willing and able to comply with scheduled visits, laboratory tests and other trial procedures.
5. Subjects must have evidence of female sexual arousal disorder (Arousal-Cognition with either Arousal-Sensation or Arousal-Lubrication) as determined by the ASFQ. The subject will be included if the Arousal-Cognition and Arousal-Sensation/Arousal-Lubrication scores are within the appropriate range as outlined in the scoring guidance.
6. Subjects who experience personal distress due to FSD as assessed by the Measure of Female Sexual Distress (MFSD). The subject will be included if the score is within the appropriate range as outlined in the scoring guidance.

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:
1. Subjects whose sexual dysfunction is considered to be situational ie, limited to certain types of stimulation, situation or specific partners.
2. Subjects who have significant dyspareunia, which is due to an inflammatory or anatomical condition (eg, pelvic inflammatory disease, vulvovestibulitis, fibroids).
3. 12-lead ECG demonstrating QTc >450 msec at screening.
4. Subjects who have sexual aversion disorder.
5. Subjects with any other major psychological or sexual disorder, not otherwise listed in the inclusion criteria, which is considered to be the primary diagnosis explaining the sexual dysfunction.
6. Subjects with otherwise treatable causes of FSAD including inadequately controlled diabetes, thyroid dysfunction or clinical significant hyperprolactinemia.
7. Subjects who currently participate in a structured psychosexual therapy program.
8. Subjects with a recent (past 6 months) history of alcohol or controlled substance abuse.
9. Subjects who drink more than 21 units of alcohol per week. (1 unit = 285 mL of beer or 25 mL of spirits or 125 mL of wine).
10. Subjects who have undergone major surgery in the past 6 months.
11. Subjects who have participated in another experimental trial within the last 30 days.
12. Subjects with any clinically significant abnormality following review of pre-study laboratory data and full physical examination.
13. Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
14. Subjects with a history of seizure disorder.
15. History of febrile illness within 5 days prior to the first dose.
16. Subjects with any condition possibly affecting drug absorption (eg, gastrectomy).
17. Subjects who are receiving drugs known to inhibit CYP3A4, such as ketoconazole
(systemic), erythromycin, cimetidine, clarithromycin, fluvoxamine, itraconazole (systemic), voriconazole, protease inhibitors.
18. Subjects who have received treatment for any major psychiatric disorder (eg, psychosis or hospitalization due to major depression) within the past 12 months. Subjects on SSRIs (selective serotonin re-uptake inhibitors), SNRIs (selective noradrenaline reuptake inhibitors), tricyclic antidepressants as well as bupropion will be allowed into the study as long as their dosage has been stable for at least three consecutive months prior to entry. This same dosage must be maintained throughout the study.
19. Subjects 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 study, or who may increase the risk to themselves or others by participating.
20. In the opinion of the investigator, a subject who is not likely to complete the study for whatever reason.

Additional Exclusion Criteria (only for subjects undergoing Vaginal Blood Flow assessments)
1. Subjects who have had previous surgery to the vagina (including that for stress incontinence or vaginal hysterectomy) and those who have any anatomical abnormality of the vagina.
2. Subjects with a recent (past 3 months) exacerbation of pelvic inflammatory disease, a recent untreated vaginal infection, salpingitis, or other severe or chronic gynecologic disease.
3. Subjects who have a history of gynaecological malignancy or those wi

Age minimum:
Age maximum:
Gender:
Female: yes
Male: no

Health Condition(s) or Problem(s) studied

Female Sexual Dysfunction
MedDRA version: 9.1 Level: LLT Classification code 10057671 Term: Female sexual dysfunction

Intervention(s)

Product Name: PF-00446687
Product Code: PF-00446687
Pharmaceutical Form: Powder for oral solution
CAS Number: 862281-92-3
Current Sponsor code: PF-00446687
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Powder for oral solution
Route of administration of the placebo: Oral use

Primary Outcome(s)

Primary end point(s): Main endpoints:
• Arousal and desire domain changes from pre-dose baseline as assessed by the Acute Female Sexual Desire and Arousal Scale (AFSDAS) questionnaire for each of the erotic and non-erotic segments (including the 2 hour immediate post-dose segment).
• Diary days 1 to 7.

Heat Wash-out endpoints (at one selected site only) – if performed:
• Vaginal Blood Flow (VBF, measured as mL/(100 g tissue x min)) changes from pre-dose baseline for each of the erotic and non-erotic segments (including the 2 hours immediate post-dose segment). Additional summaries derived from the heat wash-out method will also be explored.

Main Objective: • To assess the effect of single doses of PF-00446687 on acute sexual arousal and sexual interest as assessed by questionnaires in post-menopausal women suffering from FSD.
• To assess the effect of single doses of PF-00446687 on medium-term (one week) sexual arousal and sexual interest as assessed by a diary in post-menopausal women suffering from FSD.

Secondary Objective: • To assess the variability of response and repeatability of study design between two similar doses of PF-00446687.
• To assess PK of PF-00446687.
• To assess the safety and toleration of PF-00446687.
If possible to assess the effect of PF-00446687 on vaginal blood flow using the Heat
Wash-Out (HWO) technique (one pre-selected site only - Norway).

Secondary ID(s)

2007-001037-34-SE

n/a

A8361015