Hot Flashes
Conditions
Brief summary
The primary purpose of this study is to determine if PD-0299685 is effective and safe in the treatment of vasomotor symptoms (hot flashes / flushes) associated with menopause.
Interventions
DRUGPD-0299685
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Postmenopausal as defined by 6 months of spontaneous amenorrhea with serum FSH levels \>40mlU/ml and estradiol \< than = 25 pg/mL or 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy and FSH levels \> 40 mlU/ml and estradiol \< than = 25 pg/mL * Women reporting at least 50 moderate to severe vasomotor symptoms per week, recorded for seven consecutive days * Aged 40 to 70 years
Exclusion criteria
* No estrogen monotherapy or estrogen/progesterone containing drug products within applicable wash out period prior to screening * Use of SERMs, clonidine within 4 weeks of screening * Use of CNS active medication within 1 week of screening * Use of medications (SSRI; SNRI), herbal or dietary supplements, including black cohosh, soy, phytoestrogens or over the counter agent known to possibly be effective for the treatment of vasomotor symptoms, within 4 weeks of screening * Participation in clinical trial within 30 days * Significant medical or psychiatric illness within past 12 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effectiveness of PD-0299685 in reducing both the frequency and severity of vasomotor symptoms, from baseline to week 4 and week 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety profile of PD-0299685; the benefit of PD-0299685 in quality of life measures and treatment satisfaction of PD-0299685, when compared with placebo. | — |
Countries
Australia, Canada, France, South Africa, Spain, United States
Outcome results
None listed