Study Evaluating PD-0299685 for the Treatment of Vasomotor Symptoms (Hot Flashes / Flushes) Associated With Menopause

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer

Criteria

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