A Clinical Trial to Evaluate the Safety and Efficacy of Enjuvia 0.3 mg for the Treatment of Vulvovaginal Atrophy
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
1 other identifier
interventional
300
1 country
38
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2004
Shorter than P25 for phase_3
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2006
CompletedSeptember 2, 2013
January 1, 2010
1.3 years
September 13, 2005
August 30, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (1)
Safety and tolerability of Enjuvia
Duration of study
Study Arms (2)
1
EXPERIMENTAL2
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Naturally or surgically postmenopausal
- Moderate or severe symptoms of vaginal atrophy (ie, dryness, itching, pain, uncomfortable intercourse)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duramed Researchlead
Study Sites (38)
Duramed Investigational Site
Huntsville, Alabama, 35801, United States
Duramed Investigational Site
Tucson, Arizona, 85712, United States
Duramed Investigational Site
Carmichael, California, 95608, United States
Duramed Investigational Site
San Diego, California, 92103, United States
Duramed Investigational Site
San Diego, California, 92108, United States
Duramed Investigational Site
Colorado Springs, Colorado, 80909, United States
Duramed Investigational Site
Denver, Colorado, 80202, United States
Duramed Investigational Site
Gainesville, Florida, 32607, United States
Duramed Investigational Site
Miami, Florida, 33143, United States
Duramed Investigational Site
Miami, Florida, 33186, United States
Duramed Investigational Site
Sarasota, Florida, 34239, United States
Duramed Investigational Site
Venice, Florida, 34285, United States
Duramed Investigational Site
Alpharetta, Georgia, 30005, United States
Duramed Investigational Site
Boise, Idaho, 83712, United States
Duramed Investigational Site
Evansville, Indiana, 47714, United States
Duramed Investigational Site
Baton Rouge, Louisiana, 70808, United States
Duramed Investigational Site
Laurel, Maryland, 20707, United States
Duramed Investigational Site
Billings, Montana, 59101, United States
Duramed Investigational Site
Las Vegas, Nevada, 89109, United States
Duramed Investigational Site
Las Vegas, Nevada, 89128, United States
Duramed Investigational Site
Las Vegas, Nevada, 89146, United States
Duramed Investigational Site
Winston-Salem, North Carolina, 27103, United States
Duramed Investigational Site
Cleveland, Ohio, 44122, United States
Duramed Investigational Site
Columbus, Ohio, 43213, United States
Duramed Investigational Site
Mayfield Heights, Ohio, 44124, United States
Duramed Investigational Site
Oklahoma City, Oklahoma, 73112, United States
Duramed Investigational Site
Medford, Oregon, 97504, United States
Duramed Investigational Site
Pittsburgh, Pennsylvania, 15206, United States
Duramed Investigational Site
Columbia, South Carolina, 29201, United States
Duramed Investigational Site
Clarksville, Tennessee, 37043, United States
Duramed Investigational Site
Memphis, Tennessee, 38120, United States
Duramed Investigational Site
Fort Worth, Texas, 76104, United States
Duramed Investigational Site
San Antonio, Texas, 78229, United States
Duramed Investigational Site
Sugarland, Texas, 77478, United States
Duramed Investigational Site
Newport News, Virginia, 23602, United States
Duramed Investigational Site
Norfolk, Virginia, 23507, United States
Duramed Investigational Site
Spokane, Washington, 99207, United States
Duramed Investigational Site
Tacoma, Washington, 98405, United States
Related Publications (1)
Simon JA, Reape KZ, Wininger S, Hait H. Randomized, multicenter, double-blind, placebo-controlled trial to evaluate the efficacy and safety of synthetic conjugated estrogens B for the treatment of vulvovaginal atrophy in healthy postmenopausal women. Fertil Steril. 2008 Oct;90(4):1132-8. doi: 10.1016/j.fertnstert.2007.07.1359. Epub 2007 Dec 3.
PMID: 18053998DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Duraemd Protocol Chair
Duramed Research, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 20, 2005
Study Start
November 1, 2004
Primary Completion
February 1, 2006
Study Completion
February 1, 2006
Last Updated
September 2, 2013
Record last verified: 2010-01