Menopause Clinical Trial
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
| Verified date | February 2017 |
| Source | Novo Nordisk A/S |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 309 |
| Est. completion date | May 2007 |
| Est. primary completion date | May 2007 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 45 Years and older |
| Eligibility |
Inclusion Criteria: - Postmenopausal women whose last menstruation was at least two years previously |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Novo Nordisk Investigational Site | Kingston | |
| Canada | Novo Nordisk Investigational Site | Montreal | |
| Canada | Novo Nordisk Investigational Site | Quebec City | |
| Canada | Novo Nordisk Investigational Site | Toronto | |
| Canada | Novo Nordisk Investigational Site | Toronto | |
| Canada | Novo Nordisk Investigational Site | Winnipeg | |
| United States | Novo Nordisk Investigational Site | Alpharetta | Georgia |
| United States | Novo Nordisk Investigational Site | Boise | Idaho |
| United States | Novo Nordisk Investigational Site | Carmichael | California |
| United States | Novo Nordisk Investigational Site | Charleston | South Carolina |
| United States | Novo Nordisk Investigational Site | Charlotte | North Carolina |
| United States | Novo Nordisk Investigational Site | Clearwater | Florida |
| United States | Novo Nordisk Investigational Site | Cleveland | Ohio |
| United States | Novo Nordisk Investigational Site | Columbia | South Carolina |
| United States | Novo Nordisk Investigational Site | Columbus | Ohio |
| United States | Novo Nordisk Investigational Site | Daytona Beach | Florida |
| United States | Novo Nordisk Investigational Site | Denver | Colorado |
| United States | Novo Nordisk Investigational Site | Denver | Colorado |
| United States | Novo Nordisk Investigational Site | Eugene | Oregon |
| United States | Novo Nordisk Investigational Site | Evansville | Indiana |
| United States | Novo Nordisk Investigational Site | Greenville | South Carolina |
| United States | Novo Nordisk Investigational Site | Houston | Texas |
| United States | Novo Nordisk Investigational Site | Jackson | Tennessee |
| United States | Novo Nordisk Investigational Site | Lakewood | Colorado |
| United States | Novo Nordisk Investigational Site | Laurel | Maryland |
| United States | Novo Nordisk Investigational Site | Lawrenceville | New Jersey |
| United States | Novo Nordisk Investigational Site | Lexington | Kentucky |
| United States | Novo Nordisk Investigational Site | Lincoln | Nebraska |
| United States | Novo Nordisk Investigational Site | Medford | Oregon |
| United States | Novo Nordisk Investigational Site | Memphis | Tennessee |
| United States | Novo Nordisk Investigational Site | Milwaukee | Wisconsin |
| United States | Novo Nordisk Investigational Site | Mobile | Alabama |
| United States | Novo Nordisk Investigational Site | Montgomery | Alabama |
| United States | Novo Nordisk Investigational Site | Moorestown | New Jersey |
| United States | Novo Nordisk Investigational Site | Mount Airy | North Carolina |
| United States | Novo Nordisk Investigational Site | New London | Connecticut |
| United States | Novo Nordisk Investigational Site | New York City | New York |
| United States | Novo Nordisk Investigational Site | Norfolk | Virginia |
| United States | Novo Nordisk Investigational Site | Palm Springs | Florida |
| United States | Novo Nordisk Investigational Site | Palo Alto | California |
| United States | Novo Nordisk Investigational Site | Peoria | Illinois |
| United States | Novo Nordisk Investigational Site | Philadelphia | Pennsylvania |
| United States | Novo Nordisk Investigational Site | Phoenix | Arizona |
| United States | Novo Nordisk Investigational Site | Pittsburgh | Pennsylvania |
| United States | Novo Nordisk Investigational Site | Plantation | Florida |
| United States | Novo Nordisk Investigational Site | Roswell | Georgia |
| United States | Novo Nordisk Investigational Site | San Diego | California |
| United States | Novo Nordisk Investigational Site | San Diego | California |
| United States | Novo Nordisk Investigational Site | Sandy | Utah |
| 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 | Tampa | Florida |
| United States | Novo Nordisk Investigational Site | Tucson | Arizona |
| United States | Novo Nordisk Investigational Site | West Palm Beach | Florida |
| United States | Novo Nordisk Investigational Site | West Reading | Pennsylvania |
| United States | Novo Nordisk Investigational Site | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Novo Nordisk A/S |
United States, Canada,
Mettler L, Olsen PG. Long-term treatment of atrophic vaginitis with low-dose oestradiol vaginal tablets. Maturitas. 1991 Dec;14(1):23-31. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Clinical symptoms | after 12 months | ||
| Secondary | Objective parameters (vaginal Maturation Index/Value and vaginal pH) | |||
| Secondary | Hyperplasia rate |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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