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

Last updated on March 14, 2019

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Study Location
Pfizer Investigational Site
Phoenix, Arizona, 85015 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hot Flashes
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
40-70 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Postmenopausal as defined by 6 months of spontaneous amenorrhea with serum FSH levels
>40mlU/ml and estradiol 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00314964
Pfizer
Completed
Study Evaluating PD-0299685 for the Treatment of Vasomotor Symptoms (Hot Flashes / Flushes) Associated With Menopause

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[email protected]

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