Study to Evaluate the Effects of Synthetic Conjugated Estrogens, B (SCE-B) on Nocturnal Vasomotor Symptoms in Postmenopausal Women

Verified by: Duramed Research, June 2011
First Received: December 20, 2007 | Last Updated: June 8, 2011 | Phase: Phase 4 | Start Date: December 2007
Overall Status: Completed | Estimated Enrollment: 157
  • …
  • Tell a FriendPrint

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...

Brief Summary

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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
  • Study Primary Completion Date: February 2009

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 1
    • 0.3 mg SCE-B Daily
  • Experimental: 2
    • 0.625 mg SCE-B Daily
  • Placebo Comparator: 3
    • Placebo

Outcome Measures for this Clinical Trial

Primary Measures

  • Mean Change in Average Frequency of Awakenings Due to Sleep-time Hot Flashes
    • Time Frame: Baseline to End of Treatment (Week 12)
      Safety Issue?: No

Secondary Measures

  • Mean Change in Individual Sleep Parameters on a Three-point Scale
    • Time Frame: Baseline to End of Treatment (Week 12)
      Safety Issue?: No
  • Mean Change in Stanford Sleepiness Scale
    • Time Frame: Baseline to End of Treatment (Week 12)
      Safety Issue?: No
  • Mean Change in Biochemical Markers of Bone Metabolism (N-telopeptide).
    • Time Frame: From baseline to End of Treatment (Week 12)
      Safety Issue?: No
  • Mean Change in Biochemical Markers of Bone Metabolism (Osteocalcin)
    • Time Frame: Baseline to End of Treatment (Week 12)
      Safety Issue?: No
  • Mean Change in Biochemical Markers of Bone Metabolism (Sex Hormone Binding Globulin).
    • Time Frame: Baseline to End of Treatment (12 weeks)
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Clinical Trial Investigator Information

Lead Investigator: Duramed Research Industry

Overall Clinical Trial Officials and Contacts

Study Protocol Chair Study Chair Duramed Research, Inc.  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

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

  • …
  • Tell a FriendPrint

Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.

The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00592839