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

Information source: Teva Pharmaceutical Industries
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Menopause

Intervention: Synthetic Conjugated estrogens, B (Drug); Placebo (Other)

Phase: Phase 3

Status: Completed

Sponsored by: Duramed Research

Official(s) and/or principal investigator(s):
Duraemd Protocol Chair, Study Chair, Affiliation: Duramed Research, Inc.

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Mean change in the symptom identified by the patient to be most bothersome

Mean change in vaginal pH

Mean change in maturation index

Secondary outcome: Safety and tolerability of Enjuvia

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

Minimum age: 30 Years. Maximum age: 80 Years. Gender(s): Female.

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

Locations and Contacts

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

Additional Information

Starting date: November 2004
Last updated: August 30, 2013

Page last updated: August 23, 2015

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