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

July 12, 2013 updated by: Duramed Research

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

157

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Anaheim, California, United States, 92801
        • Duramed Investigational Site
      • Sacramento, California, United States, 95821
        • Duramed Investigational Site
      • San Diego, California, United States, 92108
        • Duramed Investigational Site
    • Florida
      • Clearwater, Florida, United States, 33759
        • Duramed Investigational Site
      • West Palm Beach, Florida, United States, 33409
        • Duramed Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Duramed Investigational Site
      • Louisville, Kentucky, United States, 40291
        • Duramed Investigational Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Duramed Investigational Site
    • New Jersey
      • Moorestown, New Jersey, United States, 08057
        • Duramed Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Duramed Investigational Site
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Duramed Investigational Site
    • Ohio
      • Cleveland, Ohio, United States, 44122
        • Duramed Investigational Site
      • Mayfield Heights, Ohio, United States, 44124
        • Duramed Investigational Site
    • Oregon
      • Medford, Oregon, United States, 97504
        • Duramed Investigational Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15206
        • Duramed Investigational Site
    • South Carolina
      • Columbia, South Carolina, United States, 29201
        • Duramed Investigational Site
    • Texas
      • San Antonio, Texas, United States, 78229
        • Duramed Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Any contraindication to hormone therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
0.3 mg SCE-B Daily
Drug: SCE-B
0.3 mg or 0.625 mg SCE-B tablets daily plus matching placebo
Other Names:
  • Synthetic Conjugated Estrogens, B
  • Enjuvia
Drug: Placebo
Matching placebo for 0.3 mg and 0.625 mg tablets
Experimental: 2
0.625 mg SCE-B Daily
Drug: SCE-B
0.3 mg or 0.625 mg SCE-B tablets daily plus matching placebo
Other Names:
  • Synthetic Conjugated Estrogens, B
  • Enjuvia
Drug: Placebo
Matching placebo for 0.3 mg and 0.625 mg tablets
Placebo Comparator: 3
Placebo
Drug: Placebo
Matching placebo for 0.3 mg and 0.625 mg tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change in Average Frequency of Awakenings Due to Sleep-time Hot Flashes
Time Frame: Baseline to End of Treatment (Week 12)
Change= Week 12 weekly average awakening score - Baseline weekly average awakening score for the intent-to-treat cohort
Baseline to End of Treatment (Week 12)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change in Individual Sleep Parameters on a Three-point Scale
Time Frame: Baseline to End of Treatment (Week 12)
Change= Week 12 weekly average sleep quality score - Baseline weekly average sleep quality score for the intent-to-treat cohort. The sleep quality was derived from the subject self-assessment of sleep quality graded on a three-point scale (3=excellent, 2=good, 1=poor sleep quality)
Baseline to End of Treatment (Week 12)
Mean Change in Stanford Sleepiness Scale
Time Frame: Baseline to End of Treatment (Week 12)
Change= Week 12 score - Baseline Score. Daytime sleepiness was derived from the subject self-assessment how they felt at a particular time of day. Subjects rated daytime sleepiness on the 7 point Stanford Sleepiness Scale (1=most alert to 7=sleepiest).
Baseline to End of Treatment (Week 12)
Mean Change in Biochemical Markers of Bone Metabolism (N-telopeptide).
Time Frame: From baseline to End of Treatment (Week 12)
Change= Week 12 biochemical markers of bone metabolism (N-telopeptide) - Baseline biochemical markers of bone metabolism values for the intent-to-treat cohort.
From baseline to End of Treatment (Week 12)
Mean Change in Biochemical Markers of Bone Metabolism (Osteocalcin)
Time Frame: Baseline to End of Treatment (Week 12)
Change= Week 12 biochemical markers of bone metabolism (Osteocalcin) - Baseline biochemical markers of bone metabolism values for the intent-to-treat cohort.
Baseline to End of Treatment (Week 12)
Mean Change in Biochemical Markers of Bone Metabolism (Sex Hormone Binding Globulin).
Time Frame: Baseline to End of Treatment (12 weeks)
Change= Week 12 biochemical markers of bone metabolism (Sex Hormone Binding Globulin) - Baseline biochemical markers of bone metabolism values for the intent-to-treat cohort.
Baseline to End of Treatment (12 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duramed Research

Investigators

  • Study Chair: Study Protocol Chair, Duramed Research, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

December 20, 2007

First Submitted That Met QC Criteria

January 11, 2008

First Posted (Estimate)

January 14, 2008

Study Record Updates

Last Update Posted (Estimate)

July 19, 2013

Last Update Submitted That Met QC Criteria

July 12, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DR-ENJ-401

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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