Vagifem Low Dose for Postmenopausal Atrophic Vaginitis Symptoms
NCT ID: NCT00108849
Last Updated: 2017-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
309 participants
INTERVENTIONAL
2005-03-31
2007-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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estradiol, 10 mcg
Eligibility Criteria
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Inclusion Criteria
45 Years
FEMALE
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Mobile, Alabama, United States
Novo Nordisk Investigational Site
Montgomery, Alabama, United States
Novo Nordisk Investigational Site
Phoenix, Arizona, United States
Novo Nordisk Investigational Site
Tucson, Arizona, United States
Novo Nordisk Investigational Site
Carmichael, California, United States
Novo Nordisk Investigational Site
Palo Alto, California, United States
Novo Nordisk Investigational Site
San Diego, California, United States
Novo Nordisk Investigational Site
San Diego, California, United States
Novo Nordisk Investigational Site
Denver, Colorado, United States
Novo Nordisk Investigational Site
Denver, Colorado, United States
Novo Nordisk Investigational Site
Lakewood, Colorado, United States
Novo Nordisk Investigational Site
New London, Connecticut, United States
Novo Nordisk Investigational Site
Clearwater, Florida, United States
Novo Nordisk Investigational Site
Daytona Beach, Florida, United States
Novo Nordisk Investigational Site
Palm Springs, Florida, United States
Novo Nordisk Investigational Site
Plantation, Florida, United States
Novo Nordisk Investigational Site
Tampa, Florida, United States
Novo Nordisk Investigational Site
West Palm Beach, Florida, United States
Novo Nordisk Investigational Site
Alpharetta, Georgia, United States
Novo Nordisk Investigational Site
Roswell, Georgia, United States
Novo Nordisk Investigational Site
Boise, Idaho, United States
Novo Nordisk Investigational Site
Peoria, Illinois, United States
Novo Nordisk Investigational Site
Evansville, Indiana, United States
Novo Nordisk Investigational Site
Lexington, Kentucky, United States
Novo Nordisk Investigational Site
Laurel, Maryland, United States
Novo Nordisk Investigational Site
Lincoln, Nebraska, United States
Novo Nordisk Investigational Site
Lawrenceville, New Jersey, United States
Novo Nordisk Investigational Site
Moorestown, New Jersey, United States
Novo Nordisk Investigational Site
New York, New York, United States
Novo Nordisk Investigational Site
Charlotte, North Carolina, United States
Novo Nordisk Investigational Site
Mount Airy, North Carolina, United States
Novo Nordisk Investigational Site
Winston-Salem, North Carolina, United States
Novo Nordisk Investigational Site
Cleveland, Ohio, United States
Novo Nordisk Investigational Site
Columbus, Ohio, United States
Novo Nordisk Investigational Site
Eugene, Oregon, United States
Novo Nordisk Investigational Site
Medford, Oregon, United States
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, United States
Novo Nordisk Investigational Site
Pittsburgh, Pennsylvania, United States
Novo Nordisk Investigational Site
West Reading, Pennsylvania, United States
Novo Nordisk Investigational Site
Charleston, South Carolina, United States
Novo Nordisk Investigational Site
Columbia, South Carolina, United States
Novo Nordisk Investigational Site
Greenville, South Carolina, United States
Novo Nordisk Investigational Site
Jackson, Tennessee, United States
Novo Nordisk Investigational Site
Memphis, Tennessee, United States
Novo Nordisk Investigational Site
Houston, Texas, United States
Novo Nordisk Investigational Site
Sandy City, Utah, United States
Novo Nordisk Investigational Site
Norfolk, Virginia, United States
Novo Nordisk Investigational Site
Spokane, Washington, United States
Novo Nordisk Investigational Site
Spokane, Washington, United States
Novo Nordisk Investigational Site
Tacoma, Washington, United States
Novo Nordisk Investigational Site
Milwaukee, Wisconsin, United States
Novo Nordisk Investigational Site
Kingston, , Canada
Novo Nordisk Investigational Site
Montreal, , Canada
Novo Nordisk Investigational Site
Québec, , Canada
Novo Nordisk Investigational Site
Toronto, , Canada
Novo Nordisk Investigational Site
Toronto, , Canada
Novo Nordisk Investigational Site
Winnipeg, , Canada
Countries
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References
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Mettler L, Olsen PG. Long-term treatment of atrophic vaginitis with low-dose oestradiol vaginal tablets. Maturitas. 1991 Dec;14(1):23-31. doi: 10.1016/0378-5122(91)90144-f.
Derzko CM, Rohrich S, Panay N. Does age at the start of treatment for vaginal atrophy predict response to vaginal estrogen therapy? Post hoc analysis of data from a randomized clinical trial involving 205 women treated with 10 mug estradiol vaginal tablets. Menopause. 2020 Oct 5;28(2):113-118. doi: 10.1097/GME.0000000000001666.
Simon J, Nachtigall L, Ulrich LG, Eugster-Hausmann M, Gut R. Endometrial safety of ultra-low-dose estradiol vaginal tablets. Obstet Gynecol. 2010 Oct;116(4):876-883. doi: 10.1097/AOG.0b013e3181f386bb.
Simon J, Nachtigall L, Gut R, Lang E, Archer DF, Utian W. Effective treatment of vaginal atrophy with an ultra-low-dose estradiol vaginal tablet. Obstet Gynecol. 2008 Nov;112(5):1053-60. doi: 10.1097/AOG.0b013e31818aa7c3.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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VAG-2195
Identifier Type: -
Identifier Source: org_study_id
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