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| Tracking Information | |||||
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| First Received Date ICMJE | August 25, 2005 | ||||
| Last Updated Date | December 7, 2007 | ||||
| Start Date ICMJE | August 2005 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
To evaluate the efficacy of 2 low dose regimens of conjugated estrogen in the treatment of atrophic vaginitis from baseline to 12 weeks. | ||||
| Original Primary Outcome Measures ICMJE |
To evaluate the efficacy of 2 low dose regimens of conjugated estrogen in the treatment of atrophic vaginitis from baseline to 12 weeks. | ||||
| Change History | Complete list of historical versions of study NCT00137371 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
To evaluate change from baseline in the percentage of superficial cells, symptom relief, the effect of both regimens on endometrial stimulation and genital health. | ||||
| Original Secondary Outcome Measures ICMJE |
To evaluate change from baseline in the percentage of superficial cells, symptom relief, the effect of both regimens on endometrial stimuation and genital health. | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study Evaluating Conjugated Estrogen Cream for Atrophic Vaginitis | ||||
| Official Title ICMJE | Efficacy and Safety of 2 Low-Dose Regimens of Conjugated Estrogen Cream Administered Vaginally in Postmenopausal Women With Atrophic Vaginitis | ||||
| Brief Summary | 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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| Detailed Description | |||||
| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment | ||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 480 | ||||
| Completion Date | September 2007 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | 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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| Gender | Female | ||||
| Ages | 45 Years to 80 Years | ||||
| Accepts Healthy Volunteers | |||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States, Canada | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00137371 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 0713S5-413 | ||||
| Study Sponsor ICMJE | Wyeth | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Wyeth | ||||
| Verification Date | December 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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