A Clinical Trial to Evaluate the Safety and Efficacy of Enjuvia 0.3 mg for the Treatment of Vulvovaginal Atrophy
Phase 3
Completed
- Conditions
- Menopause
- Interventions
- Other: Placebo
- Registration Number
- NCT00196378
- Lead Sponsor
- Duramed Research
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 300
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Placebo - 1 Synthetic Conjugated estrogens, B -
- Primary Outcome Measures
Name Time Method Mean change in the symptom identified by the patient to be most bothersome Randomization to Week 12 Mean change in vaginal pH Randomization to Week 12 Mean change in maturation index Randomization to Week 12
- Secondary Outcome Measures
Name Time Method Safety and tolerability of Enjuvia Duration of study
Trial Locations
- Locations (1)
Duramed Investigational Site
🇺🇸Tacoma, Washington, United States