Status:
COMPLETED
Study Evaluating PD-0299685 for the Treatment of Vasomotor Symptoms (Hot Flashes / Flushes) Associated With Menopause
Lead Sponsor:
Pfizer
Conditions:
Hot Flashes
Eligibility:
FEMALE
40-70 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
527 Patients enrolled
Trial Details
Trial ID
NCT00314964
Start Date
August 1 2006
End Date
July 1 2007
Last Update
March 16 2011
Active Locations (80)
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1
Pfizer Investigational Site
Phoenix, Arizona, United States, 85015
2
Pfizer Investigational Site
Phoenix, Arizona, United States, 85032
3
Pfizer Investigational Site
Tucson, Arizona, United States, 85704
4
Pfizer Investigational Site
Tucson, Arizona, United States, 85741