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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
300
1 (0.3mg) tablet daily
1 tablet daily
Mean change in the symptom identified by the patient to be most bothersome
Time frame: Randomization to Week 12
Mean change in vaginal pH
Time frame: Randomization to Week 12
Mean change in maturation index
Time frame: Randomization to Week 12
Safety and tolerability of Enjuvia
Time frame: Duration of study
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Duramed Investigational Site
Huntsville, Alabama, United States
Duramed Investigational Site
Tucson, Arizona, United States
Duramed Investigational Site
Carmichael, California, United States
Duramed Investigational Site
San Diego, California, United States
Duramed Investigational Site
San Diego, California, United States
Duramed Investigational Site
Colorado Springs, Colorado, United States
Duramed Investigational Site
Denver, Colorado, United States
Duramed Investigational Site
Gainesville, Florida, United States
Duramed Investigational Site
Miami, Florida, United States
Duramed Investigational Site
Miami, Florida, United States
...and 28 more locations