Study to Evaluate the Effects of Synthetic Conjugated Estrogens, B (SCE-B) on Nocturnal Vasomotor Symptoms in Postmenopausal Women
Information source: Teva Pharmaceutical Industries
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Nocturnal Vasomotor Symptoms
Intervention: SCE-B (Drug); Placebo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Duramed Research Official(s) and/or principal investigator(s): Study Protocol Chair, Study Chair, Affiliation: Duramed Research, Inc.
Summary
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.
Clinical Details
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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Mean Change in Average Frequency of Awakenings Due to Sleep-time Hot Flashes
Secondary outcome: Mean Change in Individual Sleep Parameters on a Three-point ScaleMean Change in Stanford Sleepiness Scale Mean Change in Biochemical Markers of Bone Metabolism (N-telopeptide). Mean Change in Biochemical Markers of Bone Metabolism (Osteocalcin) Mean Change in Biochemical Markers of Bone Metabolism (Sex Hormone Binding Globulin).
Eligibility
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
Locations and Contacts
Duramed Investigational Site, Anaheim, California 92801, United States
Duramed Investigational Site, Sacramento, California 95821, United States
Duramed Investigational Site, San Diego, California 92108, United States
Duramed Investigational Site, Clearwater, Florida 33759, United States
Duramed Investigational Site, West Palm Beach, Florida 33409, United States
Duramed Investigational Site, Lexington, Kentucky 40509, United States
Duramed Investigational Site, Louisville, Kentucky 40291, United States
Duramed Investigational Site, Lincoln, Nebraska 68510, United States
Duramed Investigational Site, Moorestown, New Jersey 08057, United States
Duramed Investigational Site, Albuquerque, New Mexico 87102, United States
Duramed Investigational Site, Winston-Salem, North Carolina 27103, United States
Duramed Investigational Site, Cleveland, Ohio 44122, United States
Duramed Investigational Site, Mayfield Heights, Ohio 44124, United States
Duramed Investigational Site, Medford, Oregon 97504, United States
Duramed Investigational Site, Pittsburgh, Pennsylvania 15206, United States
Duramed Investigational Site, Columbia, South Carolina 29201, United States
Duramed Investigational Site, San Antonio, Texas 78229, United States
Additional Information
Starting date: December 2007
Last updated: July 12, 2013
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