Study Evaluating Conjugated Estrogen Cream for Atrophic Vaginitis
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ClinicalTrials.gov Identifier: NCT00137371 |
Recruitment Status
:
Completed
First Posted
: August 29, 2005
Last Update Posted
: December 10, 2007
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Atrophic Vaginitis Atrophy Vaginitis | Drug: PVC (daily for 21 days, 7 days off) Drug: PVC (twice weekly) | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 480 participants |
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 |
Study Start Date : | August 2005 |
Actual Study Completion Date : | September 2007 |

- To evaluate the efficacy of 2 low dose regimens of conjugated estrogen in the treatment of atrophic vaginitis from baseline to 12 weeks.
- 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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Ages Eligible for Study: | 45 Years to 80 Years (Adult, Senior) |
Sexes 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00137371

Principal Investigator: | Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer |
ClinicalTrials.gov Identifier: | NCT00137371 History of Changes |
Other Study ID Numbers: |
0713S5-413 |
First Posted: | August 29, 2005 Key Record Dates |
Last Update Posted: | December 10, 2007 |
Last Verified: | December 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 |