Vagifem Low Dose for Postmenopausal Atrophic Vaginitis Symptoms
Overview[ - collapse ][ - ]
| Purpose | 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. |
|---|---|
| Condition | Menopause Postmenopausal Vaginal Atrophy |
| Intervention | Drug: estradiol, 10 mcg |
| Phase | Phase 3 |
| Sponsor | Novo Nordisk A/S |
| Responsible Party | Novo Nordisk A/S |
| ClinicalTrials.gov Identifier | NCT00108849 |
| First Received | April 19, 2005 |
| Last Updated | October 21, 2013 |
| Last verified | October 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | April 19, 2005 |
|---|---|
| Last Updated Date | October 21, 2013 |
| Start Date | March 2005 |
| Estimated Primary Completion Date | May 2007 |
| Current Primary Outcome Measures | Clinical symptoms [Time Frame: after 12 months] [Designated as safety issue: No] |
| Current Secondary Outcome Measures |
|
Descriptive Information[ + expand ][ + ]
| Brief Title | Vagifem Low Dose for Postmenopausal Atrophic Vaginitis Symptoms |
|---|---|
| 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 |
| 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. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
| Condition |
|
| Intervention | Drug: estradiol, 10 mcg |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 309 |
| Estimated Completion Date | May 2007 |
| Estimated Primary Completion Date | May 2007 |
| Eligibility Criteria | Inclusion Criteria: - Postmenopausal women whose last menstruation was at least two years previously |
| Gender | Female |
| Ages | 45 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States, Canada |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00108849 |
|---|---|
| Other Study ID Numbers | VAG-2195 |
| Has Data Monitoring Committee | No |
| Information Provided By | Novo Nordisk A/S |
| Study Sponsor | Novo Nordisk A/S |
| Collaborators | Not Provided |
| Investigators | Study Director: Alan Moses, MD Novo Nordisk A/S |
| Verification Date | October 2013 |
Locations[ + expand ][ + ]
| Novo Nordisk Clinical Trial Call Center | Mobile, Alabama, United States, 36608 |
|---|---|
| Novo Nordisk Clinical Trial Call Center | Phoenix, Arizona, United States, 85050 |
| Novo Nordisk Clinical Trial Call Center | Tucson, Arizona, United States, 85712 |
| Novo Nordisk Clinical Trial Call Center | Carmichael, California, United States, 95608 |
| Novo Nordisk Clinical Trial Call Center | Palo Alto, California, United States, 94304 |
| Novo Nordisk Clinical Trial Call Center | San Diego, California, United States, 92108 |
| Novo Nordisk Clinical Trial Call Center | San Diego, California, United States, 92123 |
| Novo Nordisk Clinical Trial Call Center | Denver, Colorado, United States, 80218 |
| Novo Nordisk Clinical Trial Call Center | Denver, Colorado, United States, 80220 |
| Novo Nordisk Clinical Trial Call Center | Lakewood, Colorado, United States, 80228 |
| Novo Nordisk Clinical Trial Call Center | New London, Connecticut, United States, 06320 |
| Novo Nordisk Clinical Trial Call Center | Clearwater, Florida, United States, 33759 |
| Novo Nordisk Clinical Trial Call Center | Daytona Beach, Florida, United States, 32114 |
| Novo Nordisk Clinical Trial Call Center | Palm Springs, Florida, United States, 33461 |
| Novo Nordisk Clinical Trial Call Center | Plantation, Florida, United States, 33324 |
| Novo Nordisk Clinical Trial Call Center | Tampa, Florida, United States, 33607 |
| Novo Nordisk Clinical Trial Call Center | West Palm Beach, Florida, United States, 33409 |
| Novo Nordisk Clinical Trial Call Center | Alpharetta, Georgia, United States, 30005 |
| Novo Nordisk Clinical Trial Call Center | Roswell, Georgia, United States, 30075 |
| Novo Nordisk Clinical Trial Call Center | Boise, Idaho, United States, 83702 |
| Novo Nordisk Clinical Trial Call Center | Evansville, Indiana, United States, 47714 |
| Novo Nordisk Clinical Trial Call Center | Lexington, Kentucky, United States, 40536-0293 |
| Novo Nordisk Clinical Trial Call Center | Laurel, Maryland, United States, 20707 |
| Novo Nordisk Clinical Trial Call Center | Lincoln, Nebraska, United States, 68510 |
| Novo Nordisk Clinical Trial Call Center | Lawrenceville, New Jersey, United States, 08648 |
| Novo Nordisk Clinical Trial Call Center | Moorestown, New Jersey, United States, 08057 |
| Novo Nordisk Clinical Trial Call Center | New York City, New York, United States, 10016 |
| Novo Nordisk Clinical Trial Call Center | Charlotte, North Carolina, United States, 28209 |
| Novo Nordisk Clinical Trial Call Center | Mount Airy, North Carolina, United States, 27030 |
| Novo Nordisk Clinical Trial Call Center | Winston-Salem, North Carolina, United States, 27103 |
| Novo Nordisk Clinical Trial Call Center | Cleveland, Ohio, United States, 44122 |
| Novo Nordisk Clinical Trial Call Center | Columbus, Ohio, United States, 43210 |
| Novo Nordisk Clinical Trial Call Center | Eugene, Oregon, United States, 97401 |
| Novo Nordisk Clinical Trial Call Center | Medford, Oregon, United States, 97504 |
| Novo Nordisk Clinical Trial Call Center | Philadelphia, Pennsylvania, United States, 19114 |
| Novo Nordisk Clinical Trial Call Center | Pittsburgh, Pennsylvania, United States, 15206 |
| Novo Nordisk Clinical Trial Call Center | West Reading, Pennsylvania, United States, 19611 |
| Novo Nordisk Clinical Trial Call Center | Charleston, South Carolina, United States, 29401 |
| Novo Nordisk Clinical Trial Call Center | Columbia, South Carolina, United States, 29201 |
| Novo Nordisk Clinical Trial Call Center | Jackson, Tennessee, United States, 38305 |
| Novo Nordisk Clinical Trial Call Center | Memphis, Tennessee, United States, 38120 |
| Novo Nordisk Clinical Trial Call Center | Houston, Texas, United States, 77030 |
| Novo Nordisk Clinical Trial Call Center | Sandy, Utah, United States, 84070 |
| Novo Nordisk Clinical Trial Call Center | Norfolk, Virginia, United States, 23507 |
| Novo Nordisk Clinical Trial Call Center | Spokane, Washington, United States, 99207 |
| Novo Nordisk Clinical Trial Call Center | Spokane, Washington, United States, 99204 |
| Novo Nordisk Clinical Trial Call Center | Tacoma, Washington, United States, 98405 |
| Novo Nordisk Clinical Trial Call Center | Milwaukee, Wisconsin, United States, 53209 |
| Canada | Toronto, Canada, M5C 1R6 |