Study to Evaluate the Effects of SCE-B on Nocturnal Vasomotor Symptoms in Postmenopausal Women

Condition(s) targeted: Nocturnal Vasomotor Symptoms

Intervention: Enjuvia (Drug); Placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Duramed Research

Official(s) and/or principal investigator(s):
Study Protocol Chair, Study Chair, Affiliation: Duramed Research, Inc.

Overall contact:
Christine OLeary, Pharm.D, Phone: 610-747-2679, Email: coleary@barrlabs.com

This is a multi-center study to evaluate the effects of SCE-B on nocturnal vasomotor symptoms. Study duration will be approximately 16 weeks; this includes a 4-week screening period and approximately 5 scheduled clinic visits. Participants will receive one of two strengths of SCE-B tablets plus matching placebo or placebo only, and will have a physical and gynecological exams that may include transvaginal ultrasound, endometrial biopsy and a pap smear. Participants will be asked to wear a monitoring device for a portion of the study and be asked to complete a daily dairy.

Official title: A Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of SCE-B on Nocturnal Vasomotor Symptoms in Postmenopausal Women

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Mean change in average frequency of awakenings due to hot flashes

Secondary outcome:

Mean change in individual sleep patterns

Mean change in Stanford Sleepiness Scale Scores

Mean change in average frequency of awakenings due to hot flashes

Mean change in bone markers and SHBG

Minimum age: 30 Years. Maximum age: 65 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Naturally or surgically menopausal

- Minimum 7 daily or 50 weekly moderate-to-severe hot flashes

Exclusion Criteria:

- Any contraindication to hormone therapy

Christine OLeary, Pharm.D, Phone: 610-747-2679, Email: coleary@barrlabs.com

Duramed Investigational Site, Phoenix, Arizona 85050, United States; Recruiting

Duramed Investigational Site, San Diego, California 92108, United States; Recruiting

Duramed Investigational Site, Carmichael, California 95608, United States; Recruiting

Duramed Investigational Site, West Palm Beach, Florida 33409, United States; Recruiting

Duramed Investigational Site, Clearwater, Florida 33759, United States; Recruiting

Duramed Investigational Site, Louisville, Kentucky 40291, United States; Recruiting

Duramed Investigational Site, Lincoln, Nebraska 68510, United States; Recruiting

Duramed Investigational Site, Albuquerque, New Mexico 87102, United States; Recruiting

Duramed Investigational Site, Winston-Salem, North Carolina 27103, United States; Recruiting

Duramed Investigational Site, Cleveland, Ohio 44122, United States; Recruiting

Duramed Investigational Site, Mayfield Heights, Ohio 44124, United States; Recruiting

Duramed Investigational Site, Medford, Oregon 97504, United States; Recruiting

Duramed Investigational Site, Pittsburgh, Pennsylvania 15206, United States; Recruiting

Duramed Investigational Site, Columbia, South Carolina 29201, United States; Recruiting

Duramed Investigational Site, San Antonio, Texas 78229, United States; Recruiting

Starting date: December 2007
Ending date: January 2009
Last updated: February 1, 2008