A Randomized, Multicenter, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Synthetic Conjugated Estrogens, B (Enjuvia) 0.3 mg Tablets for the Treatment of Vulvovaginal Atrophy in Healthy Postmenopausal Women
Overview
- Phase
- Phase 3
- Intervention
- Synthetic Conjugated estrogens, B
- Conditions
- Menopause
- Sponsor
- Duramed Research
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Mean change in maturation index
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
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.
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
1
Intervention: Synthetic Conjugated estrogens, B
2
Intervention: Placebo
Outcomes
Primary Outcomes
Mean change in maturation index
Time Frame: Randomization to Week 12
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
Secondary Outcomes
- Safety and tolerability of Enjuvia(Duration of study)