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

Phase 2

Completed

• Conditions: Hot Flashes

• Registration Number: NCT00314964
• Lead Sponsor: Pfizer

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 available

Study Timeline

• Study First Submitted: 2006-04-13
• Study First Submitted QC: 2006-04-13
• Study First Posted: 2006-04-17
• Study Start: 2006-08
• Study Completion: 2007-07
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-14
• Last Update Posted: 2011-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 527

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇪🇸 Valencia, Spain