A Clinical Trial to Evaluate the Safety and Efficacy of Enjuvia 0.3 mg for the Treatment of Vulvovaginal Atrophy
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
Study to Evaluate the Effects of Synthetic Conjugated Estrogens, B (SCE-B) on Nocturnal Vasomotor Symptoms in Postmenopausal Women
This is a multi-center study to evaluate the effects of SCE-B on nocturnal vasomotor
symptoms. Study duration will be approximately 16 weeks; this includes a 4-week screening
period and approximately 5 scheduled clinic visits. Participants will receive one of two
strengths of SCE-B tablets plus matching placebo or placebo only, and will have a physical
and gynecological exams that may include transvaginal ultrasound, endometrial biopsy and a
pap smear. Participants will be asked to wear a monitoring device for a portion of the study
and be asked to complete a daily dairy.
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