Study Evaluating Conjugated Estrogen Cream for Atrophic Vaginitis

Wyeth is now a wholly owned subsidiary of Pfizer480 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

480

Conditions

Atrophic Vaginitis Atrophy Vaginitis

Interventions

PVC (daily for 21 days, 7 days off)DRUG

PVC (twice weekly)DRUG

Eligibility

Sex: FEMALEMin age: 45 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (49)

Outcomes

Primary Outcomes

To evaluate the efficacy of 2 low dose regimens of conjugated estrogen in the treatment of atrophic vaginitis from baseline to 12 weeks.

Secondary Outcomes

To evaluate change from baseline in the percentage of superficial cells, symptom relief, the effect of both regimens on endometrial stimulation and genital health.

Data from ClinicalTrials.gov

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Unnamed facility

Tucson, Arizona, United States

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Encinitas, California, United States

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San Diego, California, United States

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Torrance, California, United States

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Aurora, Colorado, United States

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Brooksville, Florida, United States

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Miami, Florida, United States

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St. Petersburg, Florida, United States

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Tampa, Florida, United States

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West Palm Beach, Florida, United States

...and 39 more locations