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

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

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

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

Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
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 |