NCT00196378

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

A Randomized, Multicenter, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Synthetic Conjugated Estrogens, B (Enjuvia) 0.3 mg Tablets for the Treatment of Vulvovaginal Atrophy in Healthy Postmenopausal Women

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Duramed Research · Industry
• Sex: Female
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study will include a screening period up to 4 weeks and a 12-week treatment period. The overall study duration for participants will be approximately 16 weeks. Study participants will undergo physical and gynecological exams, and blood tests for clinical laboratory assessments. All patients with a uterus will undergo transvaginal ultrasound.

Conditions

• Menopause

Interventions

Type	Name	Description
DRUG	Synthetic Conjugated estrogens, B	1 (0.3mg) tablet daily
OTHER	Placebo	1 tablet daily

Timeline

• Start date: 2004-11-01
• Primary completion: 2006-02-01
• Completion: 2006-02-01
• First posted: 2005-09-20
• Last updated: 2013-09-02

Locations

38 sites across 1 country: United States