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

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ClinicalTrials.gov Identifier: NCT00196378

Recruitment Status : Completed

First Posted : September 20, 2005

Last Update Posted : September 2, 2013

Sponsor:

Information provided by:

Teva Pharmaceutical Industries

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Menopause	Drug: Synthetic Conjugated estrogens, B Other: Placebo	Phase 3

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	300 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
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
Study Start Date :	November 2004
Actual Primary Completion Date :	February 2006
Actual Study Completion Date :	February 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Estrogens, conjugated Estrogens, conjugated synthetic B Estrogens

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1	Drug: Synthetic Conjugated estrogens, B 1 (0.3mg) tablet daily Other Name: Enjuvia
Placebo Comparator: 2	Other: Placebo 1 tablet daily

Outcome Measures

Primary Outcome Measures :

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 ]
Mean change in maturation index [ Time Frame: Randomization to Week 12 ]

Secondary Outcome Measures :

Safety and tolerability of Enjuvia [ Time Frame: Duration of study ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	30 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00196378

Locations

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

Sponsors and Collaborators

Duramed Research

Investigators

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Study Chair:	Duraemd Protocol Chair	Duramed Research, Inc.

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2007 Dec 3.

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Responsible Party:	Duramed Protocol Chair, Duramed Research, Inc.
ClinicalTrials.gov Identifier:	NCT00196378
Other Study ID Numbers:	DR-ENJ-301
First Posted:	September 20, 2005 Key Record Dates
Last Update Posted:	September 2, 2013
Last Verified:	January 2010

Keywords provided by Teva Pharmaceutical Industries:


vaginal atrophy vaginal dryness vaginal itching vaginal pain dyspareunia

Additional relevant MeSH terms:

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Atrophy Pathological Conditions, Anatomical Estrogens Estrogens, Conjugated (USP) Estrogens, conjugated synthetic A	Estrogens, conjugated synthetic B Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs

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