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This protocol is designed to study the effect and safety of 2 low-dose regimens of conjugated estrogen cream (PVC) given vaginally in postmenopausal women with atrophic vaginitis.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PVC (daily for 21 days, 7 days off) | Drug | |||
| PVC (twice weekly) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the efficacy of 2 low dose regimens of conjugated estrogen in the treatment of atrophic vaginitis from baseline to 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate change from baseline in the percentage of superficial cells, symptom relief, the effect of both regimens on endometrial stimulation and genital health. |
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Inclusion Criteria:
Generally healthy postmenopausal women with symptoms of atrophic vaginitis including vaginal dryness, vaginal itching, vaginal burning, and/or painful intercourse.
The subject must have a clinical diagnosis of atrophic vaginitis and an intact uterus.
Exclusion Criteria:
Women who do not have a clinical diagnosis of atrophic vaginitis.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tucson | Arizona | 85715 | United States | |||
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| Encinitas |
| California |
| 92024 |
| United States |
| San Diego | California | 92108 | United States |
| Torrance | California | 90502 | United States |
| Aurora | Colorado | 80010 | United States |
| Brooksville | Florida | 34613 | United States |
| Miami | Florida | 33186 | United States |
| St. Petersburg | Florida | 33709 | United States |
| Tampa | Florida | 33066 | United States |
| West Palm Beach | Florida | 33407 | United States |
| Atlanta | Georgia | 30328 | United States |
| Augusta | Georgia | 30901 | United States |
| Chicago | Illinois | 60612 | United States |
| Metairie | Louisiana | 70006 | United States |
| Troy | Michigan | 48084 | United States |
| St Louis | Missouri | 63141 | United States |
| Omaha | Nebraska | 68134 | United States |
| New Brunswick | New Jersey | 08901 | United States |
| Chapel Hill | North Carolina | 27514 | United States |
| Winston-Salem | North Carolina | 27103 | United States |
| Oklahoma City | Oklahoma | 73112 | United States |
| Danville | Pennsylvania | 17822-2920 | United States |
| Philadelphia | Pennsylvania | 19104 | United States |
| Pittsburgh | Pennsylvania | 15206 | United States |
| Carrollton | Texas | 75006 | United States |
| Carrollton | Texas | 75010 | United States |
| Colleyville | Texas | 76034 | United States |
| Dallas | Texas | 75246 | United States |
| Houston | Texas | 77030 | United States |
| Plano | Texas | 75093 | United States |
| Charlottesville | Virginia | 22903 | United States |
| Norfolk | Virginia | 23502 | United States |
| Calgary | Alberta | T2N 4L7 | Canada |
| Coquitlam | British Columbia | V3K 3V9 | Canada |
| Langley | British Columbia | V3H 4H9 | Canada |
| Winnipeg | Manitoba | R3A 1M3 | Canada |
| Winnipeg | Manitoba | R3A 1R9 | Canada |
| Kingston | Ontario | K7L 2V7 | Canada |
| Ottawa | Ontario | K1H 7W9 | Canada |
| Toronto | Ontario | M5C 1R6 | Canada |
| Toronto | Ontario | M5G 1Z5 | Canada |
| Toronto | Ontario | M9W 4L6 | Canada |
| Montréal | Quebec | H1T 1P6 | Canada |
| Montréal | Quebec | H2X 1N8 | Canada |
| Montreal | Quebec | H3M 3A9 | Canada |
| Pointe-Claire | Quebec | H9R 4S3 | Canada |
| Québec | Quebec | G1L 3L5 | Canada |
| Shawinigan | Quebec | G9N 2H6 | Canada |
| Sherbrooke | Quebec | J1H 5N4 | Canada |
| ID | Term |
|---|---|
| D059268 | Atrophic Vaginitis |
| D001284 | Atrophy |
| D014627 | Vaginitis |
| ID | Term |
|---|---|
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D011143 | Polyvinyl Chloride |
| ID | Term |
|---|---|
| D011145 | Polyvinyls |
| D014753 | Vinyl Compounds |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010969 | Plastics |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D020724 | Elastomers |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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