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

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00196378
First received: September 13, 2005
Last updated: August 30, 2013
Last verified: January 2010
  Purpose

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 Intervention Phase
Menopause
Drug: Synthetic Conjugated estrogens, B
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Mean change in the symptom identified by the patient to be most bothersome [ Time Frame: Randomization to Week 12 ] [ Designated as safety issue: No ]
  • Mean change in vaginal pH [ Time Frame: Randomization to Week 12 ] [ Designated as safety issue: No ]
  • Mean change in maturation index [ Time Frame: Randomization to Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability of Enjuvia [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: November 2004
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Synthetic Conjugated estrogens, B
1 (0.3mg) tablet daily
Other Name: Enjuvia
Placebo Comparator: 2 Other: Placebo
1 tablet daily

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.

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00196378

  Hide Study Locations
Locations
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, 89146
Duramed Investigational Site
Las Vegas, Nevada, United States, 89109
Duramed Investigational Site
Las Vegas, Nevada, United States, 89128
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
Study Chair: Duraemd Protocol Chair Duramed Research, Inc.
  More Information

No publications provided by Teva Pharmaceutical Industries

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Duramed Protocol Chair, Duramed Research, Inc.
ClinicalTrials.gov Identifier: NCT00196378     History of Changes
Other Study ID Numbers: DR-ENJ-301
Study First Received: September 13, 2005
Last Updated: August 30, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Teva Pharmaceutical Industries:
vaginal atrophy
vaginal dryness
vaginal itching
vaginal pain
dyspareunia

Additional relevant MeSH terms:
Atrophy
Pathological Conditions, Anatomical
Estrogens, Conjugated (USP)
Estrogens
Estrogens, conjugated synthetic A
Estrogens, conjugated synthetic B
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014