Clinical Trial: Study Evaluating Conjugated Estrogen Cream for Atrophic Vaginitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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.

Detailed Summary:
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Current Primary Outcome: 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: Same as current

Current Secondary Outcome: 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: To evaluate change from baseline in the percentage of superficial cells, symptom relief, the effect of both regimens on endometrial stimuation and genital health.

Information By: Wyeth is now a wholly owned subsidiary of Pfizer

Dates:
Date Received: August 25, 2005
Date Started: August 2005
Date Completion:
Last Updated: December 7, 2007
Last Verified: December 2007