A Clinical Trial to Evaluate the Safety and Efficacy of DR-2041(Synthetic Conjugated Estrogens, A) for Treatment of Vulvovaginal Atrophy

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

This is a four-arm, randomized, double-blind, parallel group, placebo-controlled study to compare the effects of two doses of DR-2041(Synthetic Conjugated Estrogens, A) Vaginal Cream on vulvovaginal atrophy in postmenopausal women with or without a hysterectomy and/or oophorectomy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duramed Research
• Treatments: Estrogens; Estrogens, Conjugated (USP); Estrogens, conjugated synthetic A

Criteria

Inclusion Criteria:

• Naturally or surgically menopausal

• Moderate or severe symptoms of vaginal atrophy (ie, dryness, itching, pain, uncomfortable intercourse)

Exclusion Criteria:

• Known sensitivity or contraindication to estrogens or progestins

• History or current diagnosis endometrial hyperplasia

• Recent history of vaginal bleeding of unknown cause

• Recent history or diagnosis of endometriosis

• Any contraindication to estrogen therapy