NCT00361569

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

A Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial to Compare the Effects of 12 Weeks of Treatment With DR-2041(Synthetic Conjugated Estrogens, A) Vaginal Cream vs. Placebo Vaginal Cream on Vulvovaginal Atrophy in Healthy Postmenopausal Women

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 622 (actual)
• Sponsor: Duramed Research · Industry
• Sex: Female
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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	DR-2041a	1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
DRUG	DR-2041b	2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
OTHER	Placebo	1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
OTHER	Placebo	2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter

Timeline

• Start date: 2006-08-01
• Primary completion: 2007-09-01
• Completion: 2007-09-01
• First posted: 2006-08-08
• Last updated: 2015-04-20
• Results posted: 2009-04-14

Locations

97 sites across 1 country: United States