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”

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.

Study Type: Interventional

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

Study Primary Completion Date: January 2009

Intervention(s) in this Clinical Trial

• Drug: Enjuvia
  • 0.3mg or 0.625mg tablets daily plus matching placebo
• Drug: Placebo
  • Matching placebo for 0.3mg and 0.625mg tablets

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Experimental: 2
• Placebo Comparator: 3

Primary Measures

• Mean change in average frequency of awakenings due to hot flashes
  • Time Frame: Weekly and from Screening to End of Treatment
    Safety Issue?: No

Secondary Measures

• Mean change in individual sleep patterns
  • Time Frame: Weekly and from Screening to End of Treatment
    Safety Issue?: No
• Mean change in Stanford Sleepiness Scale Scores
  • Time Frame: Each study visit and from Screening to End of Treatment
    Safety Issue?: No
• Mean change in average frequency of awakenings due to hot flashes
  • Time Frame: Monthly and from Screening to End of Treatment based on monitoring device data
    Safety Issue?: No
• Mean change in bone markers and SHBG
  • Time Frame: From baseline to End of Treatment
    Safety Issue?: No

Inclusion Criteria:

• Naturally or surgically menopausal
• Minimum 7 daily or 50 weekly moderate-to-severe hot flashes

Exclusion Criteria:

• Any contraindication to hormone therapy

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 30 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Duramed Research

Overall Clinical Trial Officials and Contacts

Study Protocol Chair Study Chair Duramed Research, Inc.  

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

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00592839

Study ID Number: DR-ENJ-401

ClinicalTrials.gov Identifier: NCT00592839

Health Authority: United States: Food and Drug Administration