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-Blind 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:
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) |
| Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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 |
| Health Authority: | Canada: Health Canada United States: Food and Drug Administration |
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 30, 2016