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

Pfizer

Status and phase

Completed

Phase 2

Conditions

Hot Flashes

Treatments

Drug: PD-0299685

Study type

Interventional

Funder types

Industry

Identifiers

NCT00314964

A4291023

Details and patient eligibility

About

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.

Enrollment

527 patients

Sex

Female

Ages

40 to 70 years old

Volunteers

No Healthy Volunteers

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