A Clinical Trial to Evaluate the Safety and Efficacy of Enjuvia 0.3 mg for the Treatment of Vulvovaginal Atrophy

• Status: Completed
• Trial end date: 2006-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

This is a two-arm, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy of Enjuvia 0.3 mg tablets for the treatment of moderate to severe symptoms of 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; Estrogens, conjugated synthetic B

Criteria

Inclusion Criteria:

• Naturally or surgically postmenopausal

• 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 of endometrial hyperplasia

• Recent history of vaginal bleeding of unknown cause

• Recent history or diagnosis of endometriosis

• Any contraindication to estrogen therapy