A Clinical Trial to Evaluate the Safety and Efficacy of DR-2041 for Treatment of Vulvovaginal Atrophy

Condition(s) targeted: Menopause

Intervention: DR-2041a (Drug); DR-2041b (Drug); Placebo (Other); Placebo (Other)

Phase: Phase 3

Status: Completed

Sponsored by: Duramed Research

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

This is a four-arm, randomized, double-blind, parallel group, placebo-controlled study to compare the effects of two doses of DR-2041 Vaginal Cream on vulvovaginal atrophy in postmenopausal women with or without a hysterectomy and/or oophorectomy.

Official title: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial to Compare the Effects of 12 Weeks of Treatment With DR-2041 Vaginal Cream vs. Placebo Vaginal Cream on Vulvovaginal Atrophy in Healthy Postmenopausal Women

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

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 DR-2041

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.

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

Criteria:

Inclusion Criteria:

- Naturally or surgically menopausal

- Moderate or severe symptoms of vaginal atropy (ie, dryness, itching, pain,

uncomfortable intercourse)

Exclusion Criteria:

- Known sensitivity or contraindication to estrogens or progestins

- History or current diagnosis endometrial hyperplasia

- Recent history of vaginal bleeding of unknown cause

- Recent history or diagnosis of endometriosis

- Any contraindication to estrogen therapy

Duramed Investigational Site, Montgomery, Alabama 36608, United States

Duramed Investigational Site, Mobile, Alabama 36608, United States

Duramed Investigational Site, Huntsville, Alabama 35801, United States

Duramed Investigational Site, Phoenix, Arizona 85031, United States

Duramed Investigational Site, Tucson, Arizona 85710, United States

Duramed Investigational Site, Phoenix, Arizona 85015, United States

Duramed Investigational Site, Phoenix, Arizona 85032, United States

Duramed Investigational Site, Fresno, California 93710, United States

Duramed Investigational Site, San Diego, California 92123, United States

Duramed Investigational Site, San Diego, California 92103, United States

Duramed Investigational Site, San Ramon, California 94583, United States

Duramed Investigational Site, San Diego, California 92108, United States

Duramed Investigational Site, Carmichael, California 95608, United States

Duramed Investigational Site, Colorado Springs, Colorado 80909, United States

Duramed Investigational Site, Pueblo, Colorado 81001, United States

Duramed Investigational Site, New London, Connecticut 06320, United States

Duramed Investigational Site, Venice, Florida 34292, United States

Duramed Investigational Site, Weston, Florida 33331, United States

Duramed Investigational Site, Miami, Florida 33143, United States

Duramed Investigational Site, Tampa, Florida 33606, United States

Duramed Investigational Site, Stuart, Florida 34996, United States

Duramed Investigational Site, Gainesville, Florida 32607, United States

Duramed Investigational Site, Jacksonville, Florida 32207, United States

Duramed Investigational Site, West Palm Beach, Florida 33409, United States

Duramed Investigational Site, Leesburg, Florida 34748, United States

Duramed Investigational Site, Pinellas Park, Florida 33781, United States

Duramed Investigational Site, West Palm Beach, Florida 33407, United States

Duramed Investigational Site, Clearwater, Florida 33756, United States

Duramed Investigational Site, Tampa, Florida 33607, United States

Duramed Investigational Site, Clearwater, Florida 33759, United States

Duramed Investigational Site, Sandy Springs, Georgia 30328, United States

Duramed Investigational Site, Atlanta, Georgia 30342, United States

Duramed Investigational Site, Douglasville, Georgia 30134, United States

Duramed Investigational Site, Decatur, Georgia 30034, United States

Duramed Investigational Site, Alpharetta, Georgia 30005, United States

Duramed Investigational Site, Augusta, Georgia 30901, United States

Duramed Investigational Site, Chicago, Illinois 60611, United States

Duramed Investigational Site, Chicago, Illinois 60612, United States

Duramed Investigational Site, Evansville, Indiana 47714, United States

Duramed Investigational Site, Overland Park, Kansas 66215, United States

Duramed Investigational Site, Louisville, Kentucky 40291, United States

Duramed Investigational Site, Lexington, Kentucky 40509, United States

Duramed Investigational Site, Madisonville, Kentucky 42431, United States

Duramed Investigational Site, Shreveport, Louisiana 71106, United States

Duramed Investigational Site, Baltimore, Maryland 21224, United States

Duramed Investigational Site, Livonia, Michigan 48152, United States

Duramed Investigational Site, Lincoln, Nebraska 68510, United States

Duramed Investigational Site, Las Vegas, Nevada 89146, United States

Duramed Investigational Site, Lebanon, New Hampshire 03756, United States

Duramed Investigational Site, Lawrenceville, New Jersey 08648, United States

Duramed Investigational Site, Moorestown, New Jersey 08057, United States

Duramed Investigational Site, New Brunswick, New Jersey 08901, United States

Duramed Investigational Site, Albuquerque, New Mexico 87102, United States

Duramed Investigational Site, Williamsville, New York 14221, United States

Duramed Investigational Site, Johnson City, New York 13790, United States

Duramed Investigational Site, Raleigh, North Carolina 27607, United States

Duramed Investigational Site, Winston-Salem, North Carolina 27103, United States

Duramed Investigational Site, Minot, North Dakota 58701, United States

Duramed Investigational Site, Jamestown, North Dakota 58401, United States

Duramed Investigational Site, Columbus, Ohio 43205, United States

Duramed Investigational Site, Columbus, Ohio 43213, United States

Duramed Investigational Site, Cincinnati, Ohio 45236, United States

Duramed Investigational Site, Mayfield Heights, Ohio 44124, United States

Duramed Investigational Site, Columbus, Ohio 43212, United States

Duramed Investigational Site, Cleveland, Ohio 44122, United States

Duramed Investigational Site, Portland, Oregon 97210, United States

Duramed Investigational Site, Medford, Oregon 97504, United States

Duramed Investigational Site, Portland, Oregon 97239, United States

Duramed Investigational Site, Pittsburgh, Pennsylvania 15206, United States

Duramed Investigational Site, King of Prussia, Pennsylvania 19406, United States

Duramed Investigational Site, Philadelphia, Pennsylvania 19107, United States

Duramed Investigational Site, Allentown, Pennsylvania 18104, United States

Duramed Investigational Site, Philadelphia, Pennsylvania 19114, United States

Duramed Investigational Site, Strafford, Pennsylvania 19087, United States

Duramed Investigational Site, Media, Pennsylvania 19063, United States

Duramed Investigational Site, Rosemont, Pennsylvania 19010, United States

Duramed Investigational Site, Warwick, Rhode Island 02886, United States

Duramed Investigational Site, Charleston, South Carolina 29401, United States

Duramed Investigational Site, Columbia, South Carolina 29201, United States

Duramed Investigational Site, Charleston, South Carolina 29425-0100, United States

Duramed Investigational Site, Watertown, South Dakota 57201, United States

Duramed Investigational Site, Memphis, Tennessee 38120, United States

Duramed Investigational Site, Nashville, Tennessee 37203, United States

Duramed Investigational Site, Austin, Texas 78759, United States

Duramed Investigational Site, Houston, Texas 77015, United States

Duramed Investigational Site, Dallas, Texas 75390-9032, United States

Duramed Investigational Site, Houston, Texas 77074, United States

Duramed Investigational Site, Corpus Christi, Texas 78414, United States

Duramed Investigational Site, Houston, Texas 77024, United States

Duramed Investigational Site, San Antonio, Texas 78229, United States

Duramed Investigational Site, Waco, Texas 76712, United States

Duramed Investigational Site, Houston, Texas 77030, United States

Duramed Investigational Site, Austin, Texas 78748, United States

Duramed Investigational Site, Williston, Vermont 05495, United States

Duramed Investigational Site, Newport News, Virginia 23602, United States

Duramed Investigational Site, Tacoma, Washington 98405, United States

Duramed Investigational Site, Spokane, Washington 99207, United States

NAMS- Menopause Guidebook

NIH- Menopausal Hormone Therapy

Starting date: August 2006
Ending date: September 2007
Last updated: March 20, 2008