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Vagifem Low Dose for Postmenopausal Atrophic Vaginitis Symptoms

Information source: Novo Nordisk A/S
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Menopause; Postmenopausal Vaginal Atrophy

Intervention: estradiol, 10 mcg (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novo Nordisk A/S

Official(s) and/or principal investigator(s):
Alan Moses, MD, Study Director, Affiliation: Novo Nordisk A/S

Summary

This trial is conducted in North America. The purpose of this study is to determine if Vagifem Low Dose is an effective and safe treatment for patients suffering from postmenopausal atrophic vaginitis.

Clinical Details

Official title: A 12 Month Double-blind, Randomized, Parallel-group, Placebo-controlled, Multi-center Trial to Investigate the Efficacy and Safety of Vagifem Low Dose (10 Mcg 17beta-estradiol Vaginal Tablet) for the Treatment of Postmenopausal Atrophic Vaginitis Symptoms

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Clinical symptoms

Secondary outcome:

Objective parameters (vaginal Maturation Index/Value and vaginal pH)

Hyperplasia rate

Eligibility

Minimum age: 45 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Postmenopausal women whose last menstruation was at least two years previously

Locations and Contacts

Toronto M5C 1R6, Canada

Novo Nordisk Clinical Trial Call Center, Mobile, Alabama 36608, United States

Novo Nordisk Clinical Trial Call Center, Phoenix, Arizona 85050, United States

Novo Nordisk Clinical Trial Call Center, Tucson, Arizona 85712, United States

Novo Nordisk Clinical Trial Call Center, Carmichael, California 95608, United States

Novo Nordisk Clinical Trial Call Center, Palo Alto, California 94304, United States

Novo Nordisk Clinical Trial Call Center, San Diego, California 92108, United States

Novo Nordisk Clinical Trial Call Center, San Diego, California 92123, United States

Novo Nordisk Clinical Trial Call Center, Denver, Colorado 80220, United States

Novo Nordisk Clinical Trial Call Center, Denver, Colorado 80218, United States

Novo Nordisk Clinical Trial Call Center, Lakewood, Colorado 80228, United States

Novo Nordisk Clinical Trial Call Center, New London, Connecticut 06320, United States

Novo Nordisk Clinical Trial Call Center, Clearwater, Florida 33759, United States

Novo Nordisk Clinical Trial Call Center, Daytona Beach, Florida 32114, United States

Novo Nordisk Clinical Trial Call Center, Palm Springs, Florida 33461, United States

Novo Nordisk Clinical Trial Call Center, Plantation, Florida 33324, United States

Novo Nordisk Clinical Trial Call Center, Tampa, Florida 33607, United States

Novo Nordisk Clinical Trial Call Center, West Palm Beach, Florida 33409, United States

Novo Nordisk Clinical Trial Call Center, Alpharetta, Georgia 30005, United States

Novo Nordisk Clinical Trial Call Center, Roswell, Georgia 30075, United States

Novo Nordisk Clinical Trial Call Center, Boise, Idaho 83702, United States

Novo Nordisk Clinical Trial Call Center, Evansville, Indiana 47714, United States

Novo Nordisk Clinical Trial Call Center, Lexington, Kentucky 40536-0293, United States

Novo Nordisk Clinical Trial Call Center, Laurel, Maryland 20707, United States

Novo Nordisk Clinical Trial Call Center, Lincoln, Nebraska 68510, United States

Novo Nordisk Clinical Trial Call Center, Lawrenceville, New Jersey 08648, United States

Novo Nordisk Clinical Trial Call Center, Moorestown, New Jersey 08057, United States

Novo Nordisk Clinical Trial Call Center, New York City, New York 10016, United States

Novo Nordisk Clinical Trial Call Center, Charlotte, North Carolina 28209, United States

Novo Nordisk Clinical Trial Call Center, Mount Airy, North Carolina 27030, United States

Novo Nordisk Clinical Trial Call Center, Winston-Salem, North Carolina 27103, United States

Novo Nordisk Clinical Trial Call Center, Cleveland, Ohio 44122, United States

Novo Nordisk Clinical Trial Call Center, Columbus, Ohio 43210, United States

Novo Nordisk Clinical Trial Call Center, Eugene, Oregon 97401, United States

Novo Nordisk Clinical Trial Call Center, Medford, Oregon 97504, United States

Novo Nordisk Clinical Trial Call Center, Philadelphia, Pennsylvania 19114, United States

Novo Nordisk Clinical Trial Call Center, Pittsburgh, Pennsylvania 15206, United States

Novo Nordisk Clinical Trial Call Center, West Reading, Pennsylvania 19611, United States

Novo Nordisk Clinical Trial Call Center, Charleston, South Carolina 29401, United States

Novo Nordisk Clinical Trial Call Center, Columbia, South Carolina 29201, United States

Novo Nordisk Clinical Trial Call Center, Jackson, Tennessee 38305, United States

Novo Nordisk Clinical Trial Call Center, Memphis, Tennessee 38120, United States

Novo Nordisk Clinical Trial Call Center, Houston, Texas 77030, United States

Novo Nordisk Clinical Trial Call Center, Sandy, Utah 84070, United States

Novo Nordisk Clinical Trial Call Center, Norfolk, Virginia 23507, United States

Novo Nordisk Clinical Trial Call Center, Spokane, Washington 99204, United States

Novo Nordisk Clinical Trial Call Center, Spokane, Washington 99207, United States

Novo Nordisk Clinical Trial Call Center, Tacoma, Washington 98405, United States

Novo Nordisk Clinical Trial Call Center, Milwaukee, Wisconsin 53209, United States

Additional Information

Clinical Trials at Novo Nordisk

Starting date: March 2005
Last updated: October 21, 2013

Page last updated: August 23, 2015

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