Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| estradiol, 10 mcg | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical symptoms | after 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective parameters (vaginal Maturation Index/Value and vaginal pH) | ||
| Hyperplasia rate |
Not provided
Inclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Mobile | Alabama | 36608 | United States | ||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1791769 | Result | 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. | |
| 33038141 | Derived | 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. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| 20859151 | Derived | 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. |
| 18978105 | Derived | 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. |
| ID | Term |
|---|---|
| D004958 | Estradiol |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
Not provided
Not provided