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| Sponsored by: |
Wyeth |
| Information provided by: | Wyeth |
| ClinicalTrials.gov Identifier: | NCT00137371 |
Purpose
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.
| Condition | Intervention | Phase |
|
Atrophic Vaginitis Atrophy Vaginitis |
Drug: PVC (daily for 21 days, 7 days off) Drug: PVC (twice weekly) |
Phase III |
| ChemIDplus related topics: | Estrogens, conjugated |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment |
| Official Title: | Efficacy and Safety of 2 Low-Dose Regimens of Conjugated Estrogen Cream Administered Vaginally in Postmenopausal Women With Atrophic Vaginitis |
| Estimated Enrollment: | 480 |
| Study Start Date: | August 2005 |
| Study Completion Date: | September 2007 |
Eligibility
| Ages Eligible for Study: | 45 Years to 80 Years |
| Genders Eligible for Study: | Female |
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.
Contacts and Locations![]() |
Show 49 Study Locations |
| Wyeth |
| Principal Investigator: | Medical Monitor | Wyeth |
More Information
| Study ID Numbers: | 0713S5-413 |
| First Received: | August 25, 2005 |
| Last Updated: | December 7, 2007 |
| ClinicalTrials.gov Identifier: | NCT00137371 |
| Health Authority: | Canada: Health Canada; United States: Food and Drug Administration |
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