Vagifem Low Dose for Postmenopausal Atrophic Vaginitis Symptoms
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
1 other identifier
interventional
309
2 countries
57
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2005
57 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
April 19, 2005
CompletedFirst Posted
Study publicly available on registry
April 20, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedFebruary 8, 2017
February 1, 2017
2.2 years
April 19, 2005
February 6, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical symptoms
after 12 months
Secondary Outcomes (2)
Objective parameters (vaginal Maturation Index/Value and vaginal pH)
Hyperplasia rate
Interventions
Eligibility Criteria
You may qualify if:
- Postmenopausal women whose last menstruation was at least two years previously
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (57)
Novo Nordisk Investigational Site
Mobile, Alabama, 36608, United States
Novo Nordisk Investigational Site
Montgomery, Alabama, 36106, United States
Novo Nordisk Investigational Site
Phoenix, Arizona, 85050, United States
Novo Nordisk Investigational Site
Tucson, Arizona, 85712, United States
Novo Nordisk Investigational Site
Carmichael, California, 95608, United States
Novo Nordisk Investigational Site
Palo Alto, California, 94304, United States
Novo Nordisk Investigational Site
San Diego, California, 92108, United States
Novo Nordisk Investigational Site
San Diego, California, 92123, United States
Novo Nordisk Investigational Site
Denver, Colorado, 80218, United States
Novo Nordisk Investigational Site
Denver, Colorado, 80220, United States
Novo Nordisk Investigational Site
Lakewood, Colorado, 80228, United States
Novo Nordisk Investigational Site
New London, Connecticut, 06320, United States
Novo Nordisk Investigational Site
Clearwater, Florida, 33759, United States
Novo Nordisk Investigational Site
Daytona Beach, Florida, 32114, United States
Novo Nordisk Investigational Site
Palm Springs, Florida, 33461, United States
Novo Nordisk Investigational Site
Plantation, Florida, 33324, United States
Novo Nordisk Investigational Site
Tampa, Florida, 33607, United States
Novo Nordisk Investigational Site
West Palm Beach, Florida, 33409, United States
Novo Nordisk Investigational Site
Alpharetta, Georgia, 30005, United States
Novo Nordisk Investigational Site
Roswell, Georgia, 30075, United States
Novo Nordisk Investigational Site
Boise, Idaho, 83702, United States
Novo Nordisk Investigational Site
Peoria, Illinois, 61615, United States
Novo Nordisk Investigational Site
Evansville, Indiana, 47714, United States
Novo Nordisk Investigational Site
Lexington, Kentucky, 40536-0293, United States
Novo Nordisk Investigational Site
Laurel, Maryland, 20707, United States
Novo Nordisk Investigational Site
Lincoln, Nebraska, 68510, United States
Novo Nordisk Investigational Site
Lawrenceville, New Jersey, 08648, United States
Novo Nordisk Investigational Site
Moorestown, New Jersey, 08057, United States
Novo Nordisk Investigational Site
New York, New York, 10016, United States
Novo Nordisk Investigational Site
Charlotte, North Carolina, 28209, United States
Novo Nordisk Investigational Site
Mount Airy, North Carolina, 27030, United States
Novo Nordisk Investigational Site
Winston-Salem, North Carolina, 27103, United States
Novo Nordisk Investigational Site
Cleveland, Ohio, 44122, United States
Novo Nordisk Investigational Site
Columbus, Ohio, 43210, United States
Novo Nordisk Investigational Site
Eugene, Oregon, 97401, United States
Novo Nordisk Investigational Site
Medford, Oregon, 97504, United States
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, 19114, United States
Novo Nordisk Investigational Site
Pittsburgh, Pennsylvania, 15206, United States
Novo Nordisk Investigational Site
West Reading, Pennsylvania, 19611, United States
Novo Nordisk Investigational Site
Charleston, South Carolina, 29401, United States
Novo Nordisk Investigational Site
Columbia, South Carolina, 29201, United States
Novo Nordisk Investigational Site
Greenville, South Carolina, 29607, United States
Novo Nordisk Investigational Site
Jackson, Tennessee, 38305, United States
Novo Nordisk Investigational Site
Memphis, Tennessee, 38120, United States
Novo Nordisk Investigational Site
Houston, Texas, 77030, United States
Novo Nordisk Investigational Site
Sandy City, Utah, 84070, United States
Novo Nordisk Investigational Site
Norfolk, Virginia, 23507, United States
Novo Nordisk Investigational Site
Spokane, Washington, 99204, United States
Novo Nordisk Investigational Site
Spokane, Washington, 99207, United States
Novo Nordisk Investigational Site
Tacoma, Washington, 98405, United States
Novo Nordisk Investigational Site
Milwaukee, Wisconsin, 53209, United States
Novo Nordisk Investigational Site
Kingston, K7L 4P8, Canada
Novo Nordisk Investigational Site
Montreal, H1T 1P6, Canada
Novo Nordisk Investigational Site
Québec, G1S 2L6, Canada
Novo Nordisk Investigational Site
Toronto, M5C 1R6, Canada
Novo Nordisk Investigational Site
Toronto, M5G 1Z5, Canada
Novo Nordisk Investigational Site
Winnipeg, R3A 1M3, Canada
Related Publications (4)
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.
PMID: 1791769RESULTDerzko 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.
PMID: 33038141DERIVEDSimon 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.
PMID: 20859151DERIVEDSimon 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.
PMID: 18978105DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2005
First Posted
April 20, 2005
Study Start
March 1, 2005
Primary Completion
May 1, 2007
Study Completion
May 1, 2007
Last Updated
February 8, 2017
Record last verified: 2017-02