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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Hot Flashes	Drug: PD-0299685	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	527 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study Evaluating PD-0299685 for Treatment of Vasomotor Symptoms Associated With Menopause
Study Start Date :	August 2006
Actual Study Completion Date :	July 2007

Arms and Interventions

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Outcome Measures

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Primary Outcome Measures :

1. Effectiveness of PD-0299685 in reducing both the frequency and severity of vasomotor symptoms, from baseline to week 4 and week 12.

Secondary Outcome Measures :

1. 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.

Eligibility Criteria

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Ages Eligible for Study:	40 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 80 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

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Additional Information:

To obtain contact information for a study center near you, click here. 

ClinicalTrials.gov Identifier:	NCT00314964 History of Changes
Other Study ID Numbers:	A4291023
First Posted:	April 17, 2006
Last Update Posted:	March 16, 2011
Last Verified:	March 2011

Additional relevant MeSH terms:

Hot Flashes; Signs and Symptoms