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

• Mean change in the symptom identified by the patient to be most bothersome [ Time Frame: Randomization to Week 12 ] [ Designated as safety issue: No ]
• Mean change in vaginal pH [ Time Frame: Randomization to Week 12 ] [ Designated as safety issue: No ]
• Mean change in maturation index [ Time Frame: Randomization to Week 12 ] [ Designated as safety issue: No ]

• Mean change in the symptom identified by the patient to be most bothersome
• Mean change in vaginal pH
• Mean change in maturation index

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.

• Drug: Synthetic Conjugated estrogens, B
  1 (0.3mg) tablet daily
  Other Name: Enjuvia
• Other: Placebo
  1 tablet daily

• Experimental: 1
  Intervention: Drug: Synthetic Conjugated estrogens, B
• Placebo Comparator: 2
  Intervention: Other: Placebo

Inclusion Criteria:

• Naturally or surgically postmenopausal
• Moderate or severe symptoms of vaginal atrophy (ie, dryness, itching, pain, uncomfortable intercourse)

Exclusion Criteria:

• Known sensitivity or contraindication to estrogens or progestins
• History or current diagnosis of endometrial hyperplasia
• Recent history of vaginal bleeding of unknown cause
• Recent history or diagnosis of endometriosis
• Any contraindication to estrogen therapy