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

August 30, 2013 updated by: Duramed Research

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Duramed Investigational Site
    • Arizona
      • Tucson, Arizona, United States, 85712
        • Duramed Investigational Site
    • California
      • Carmichael, California, United States, 95608
        • Duramed Investigational Site
      • San diego, California, United States, 92103
        • Duramed Investigational Site
      • San diego, California, United States, 92108
        • Duramed Investigational Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Duramed Investigational Site
      • Denver, Colorado, United States, 80202
        • Duramed Investigational Site
    • Florida
      • Gainesville, Florida, United States, 32607
        • Duramed Investigational Site
      • Miami, Florida, United States, 33186
        • Duramed Investigational Site
      • Miami, Florida, United States, 33143
        • Duramed Investigational Site
      • Sarasota, Florida, United States, 34239
        • Duramed Investigational Site
      • Venice, Florida, United States, 34285
        • Duramed Investigational Site
    • Georgia
      • Alpharetta, Georgia, United States, 30005
        • Duramed Investigational Site
    • Idaho
      • Boise, Idaho, United States, 83712
        • Duramed Investigational Site
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Duramed Investigational Site
    • Louisiana
      • Baton rouge, Louisiana, United States, 70808
        • Duramed Investigational Site
    • Maryland
      • Laurel, Maryland, United States, 20707
        • Duramed Investigational Site
    • Montana
      • Billings, Montana, United States, 59101
        • Duramed Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Duramed Investigational Site
      • Las Vegas, Nevada, United States, 89128
        • Duramed Investigational Site
      • Las Vegas, Nevada, United States, 89146
        • Duramed Investigational Site
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Duramed Investigational Site
    • Ohio
      • Cleveland, Ohio, United States, 44122
        • Duramed Investigational Site
      • Columbus, Ohio, United States, 43213
        • Duramed Investigational Site
      • Mayfield Heights, Ohio, United States, 44124
        • Duramed Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Duramed Investigational Site
    • Oregon
      • Medford, Oregon, United States, 97504
        • Duramed Investigational Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15206
        • Duramed Investigational Site
    • South Carolina
      • Columbia, South Carolina, United States, 29201
        • Duramed Investigational Site
    • Tennessee
      • Clarksville, Tennessee, United States, 37043
        • Duramed Investigational Site
      • Memphis, Tennessee, United States, 38120
        • Duramed Investigational Site
    • Texas
      • Fort Worth, Texas, United States, 76104
        • Duramed Investigational Site
      • San antonio, Texas, United States, 78229
        • Duramed Investigational Site
      • Sugarland, Texas, United States, 77478
        • Duramed Investigational Site
    • Virginia
      • Newport News, Virginia, United States, 23602
        • Duramed Investigational Site
      • Norfolk, Virginia, United States, 23507
        • Duramed Investigational Site
    • Washington
      • Spokane, Washington, United States, 99207
        • Duramed Investigational Site
      • Tacoma, Washington, United States, 98405
        • Duramed Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Synthetic Conjugated estrogens, B
1 (0.3mg) tablet daily
Other Names:
  • Enjuvia
Placebo Comparator: 2
Other: Placebo
1 tablet daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean change in the symptom identified by the patient to be most bothersome
Time Frame: Randomization to Week 12
Randomization to Week 12
Mean change in vaginal pH
Time Frame: Randomization to Week 12
Randomization to Week 12
Mean change in maturation index
Time Frame: Randomization to Week 12
Randomization to Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability of Enjuvia
Time Frame: Duration of study
Duration of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duramed Research

Investigators

  • Study Chair: Duraemd Protocol Chair, Duramed Research, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Primary Completion (Actual)

February 1, 2006

Study Completion (Actual)

February 1, 2006

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 14, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

September 2, 2013

Last Update Submitted That Met QC Criteria

August 30, 2013

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DR-ENJ-301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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