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

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ClinicalTrials.gov Identifier: NCT00314964
Recruitment Status : Completed
First Posted : April 17, 2006
Last Update Posted : March 16, 2011
Sponsor:
Information provided by:
Pfizer

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause

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, Older Adult)
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00314964


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Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:
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ClinicalTrials.gov Identifier: NCT00314964     History of Changes
Other Study ID Numbers: A4291023
First Posted: April 17, 2006    Key Record Dates
Last Update Posted: March 16, 2011
Last Verified: March 2011

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms