Official Title: “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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: February 2006

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.

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Placebo Comparator: 2

Primary Measures

• Mean change in the symptom identified by the patient to be most bothersome
  • Time Frame: Randomization to Week 12
    Safety Issue?: No
• Mean change in vaginal pH
  • Time Frame: Randomization to Week 12
    Safety Issue?: No
• Mean change in maturation index
  • Time Frame: Randomization to Week 12
    Safety Issue?: No

Secondary Measures

• Safety and tolerability of Enjuvia
  • Time Frame: Duration of study
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 30 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Duramed Research

Overall Clinical Trial Officials and Contacts

Duraemd Protocol Chair Study Chair Duramed Research, Inc.  

Information obtained from ClinicalTrials.gov on October 07, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00196378

Study ID Number: DR-ENJ-301

ClinicalTrials.gov Identifier: NCT00196378

Health Authority: United States: Food and Drug Administration