A Clinical Trial to Evaluate the Safety and Efficacy of Enjuvia 0.3 mg for the Treatment of Vulvovaginal Atrophy
Recruiting in Palo Alto (17 mi)
+33 other locations
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Duramed Research
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
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.
Research Team
DP
Duraemd Protocol Chair
Principal Investigator
Duramed Research, Inc.
Eligibility Criteria
Inclusion Criteria
Naturally or surgically postmenopausal
Moderate or severe symptoms of vaginal atrophy (ie, dryness, itching, pain, uncomfortable intercourse)
Treatment Details
Interventions
- Enjuvia (Estrogen)
- Placebo (Other)
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: 1Experimental Treatment1 Intervention
Group II: 2Placebo Group1 Intervention
Find a Clinic Near You
Who Is Running the Clinical Trial?
Duramed Research
Lead Sponsor
Trials
25
Recruited
16,100+