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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 Scale

Mean 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

Page last updated: August 23, 2015

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