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

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NCT00314964

Last updated on February 18, 2020
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Phoenix, Arizona, 85015 United States
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Contact
1-800-718-1021
ClinicalTrials.gov_Inquiri[email protected]
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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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Descriptive Information
Brief Title  ICMJE Study Evaluating PD-0299685 for the Treatment of Vasomotor Symptoms (Hot Flashes / Flushes) Associated With Menopause
Official Title  ICMJE A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study Evaluating PD-0299685 for Treatment of Vasomotor Symptoms Associated With Menopause
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hot Flashes
Intervention  ICMJE Drug: PD-0299685
Study Arms  ICMJE Not Provided
Publications * Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 14, 2011) 		527
Original Enrollment  ICMJE
 (submitted: April 13, 2006) 		490
Actual Study Completion Date  ICMJE July 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 40 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   France,   South Africa,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00314964
Other Study ID Numbers  ICMJE A4291023
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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