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Study Evaluating Conjugated Estrogen Cream for Atrophic Vaginitis
This study has been completed.
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00137371
First received: August 25, 2005
Last updated: December 7, 2007
Last verified: December 2007
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment |
| Official Title: | Efficacy and Safety of 2 Low-Dose Regimens of Conjugated Estrogen Cream Administered Vaginally in Postmenopausal Women With Atrophic Vaginitis |
Resource links provided by NLM:
MedlinePlus related topics:
Vaginitis
Drug Information available for:
Estrogens, conjugated
U.S. FDA Resources
Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Primary Outcome Measures:
- To evaluate the efficacy of 2 low dose regimens of conjugated estrogen in the treatment of atrophic vaginitis from baseline to 12 weeks.
Secondary Outcome Measures:
- To evaluate change from baseline in the percentage of superficial cells, symptom relief, the effect of both regimens on endometrial stimulation and genital health.
| Estimated Enrollment: | 480 |
| Study Start Date: | August 2005 |
| Study Completion Date: | September 2007 |
Eligibility| Ages Eligible for Study: | 45 Years to 80 Years (Adult, Senior) |
| Sexes Eligible for Study: | Female |
Criteria
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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00137371
Show 49 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00137371
Show 49 Study Locations
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
| Principal Investigator: | Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer |
More Information
| ClinicalTrials.gov Identifier: | NCT00137371 History of Changes |
| Other Study ID Numbers: |
0713S5-413 |
| Study First Received: | August 25, 2005 |
| Last Updated: | December 7, 2007 |
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
|
Postmenopause Vaginitis |
Additional relevant MeSH terms:
|
Atrophy Vaginitis Atrophic Vaginitis Pathological Conditions, Anatomical Vaginal Diseases Genital Diseases, Female |
Estrogens Estrogens, Conjugated (USP) Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 25, 2017