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

Completed · Phase 2

Conditions studied: Hot Flashes

In brief

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.

Key facts

Study ID

NCT00314964

Run by

Pfizer

People needed

527

Starts

2006-08-01

Expected to finish

2007-07-01

Last updated by the study team

2011-03-16

Who can join

Age: 40 and older, up to 70. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Pfizer Investigational Site — Phoenix, Arizona, United States
• Pfizer Investigational Site — Tucson, Arizona, United States
• Pfizer Investigational Site — Tucson, Arizona, United States
• Pfizer Investigational Site — Jonesboro, Arkansas, United States
• Pfizer Investigational Site — Greenbrae, California, United States
• Pfizer Investigational Site — San Diego, California, United States
• Pfizer Investigational Site — San Diego, California, United States
• Pfizer Investigational Site — New London, Connecticut, United States
• Pfizer Investigational Site — Leesburg, Florida, United States
• Pfizer Investigational Site — Longwood, Florida, United States
• Pfizer Investigational Site — Tampa, Florida, United States
• Pfizer Investigational Site — Tampa, Florida, United States
• Pfizer Investigational Site — West Palm Beach, Florida, United States
• Pfizer Investigational Site — Alanta, Georgia, United States
• Pfizer Investigational Site — Alpharetta, Georgia, United States
• Pfizer Investigational Site — Atlanta, Georgia, United States
• Pfizer Investigational Site — Decatur, Georgia, United States
• Pfizer Investigational Site — Stockbridge, Georgia, United States
• Pfizer Investigational Site — Chicago, Illinois, United States
• Pfizer Investigational Site — Indianapolis, Indiana, United States
• Pfizer Investigational Site — Indianapolis, Indiana, United States
• Pfizer Investigational Site — Indianapolis, Indiana, United States
• Pfizer Investigational Site — Baltimore, Maryland, United States
• Pfizer Investigational Site — North Dartmouth, Massachusetts, United States
• Pfizer Investigational Site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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