A Clinical Trial to Evaluate the Safety and Efficacy of DR-2041(Synthetic Conjugated Estrogens, A) for Treatment of Vulvovaginal Atrophy

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

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

Study Overview

• Status: Completed
• Conditions: Menopause
• Intervention / Treatment: Drug: DR-2041a; Drug: DR-2041b; Other: Placebo; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 622
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Duramed Investigational Site
    • Mobile, Alabama, United States, 36608
      • Duramed Investigational Site
    • Montgomery, Alabama, United States, 36608
      • Duramed Investigational Site
  • Arizona
    • Phoenix, Arizona, United States, 85015
      • Duramed Investigational Site
    • Phoenix, Arizona, United States, 85031
      • Duramed Investigational Site
    • Phoenix, Arizona, United States, 85032
      • Duramed Investigational Site
    • Tucson, Arizona, United States, 85710
      • Duramed Investigational Site
  • California
    • Carmichael, California, United States, 95608
      • Duramed Investigational Site
    • Fresno, California, United States, 93710
      • Duramed Investigational Site
    • San Diego, California, United States, 92108
      • Duramed Investigational Site
    • San Diego, California, United States, 92103
      • Duramed Investigational Site
    • San Diego, California, United States, 92123
      • Duramed Investigational Site
    • San Ramon, California, United States, 94583
      • Duramed Investigational Site
  • Colorado
    • Colorado Springs, Colorado, United States, 80909
      • Duramed Investigational Site
    • Pueblo, Colorado, United States, 81001
      • Duramed Investigational Site
  • Connecticut
    • New London, Connecticut, United States, 06320
      • Duramed Investigational Site
  • Florida
    • Clearwater, Florida, United States, 33759
      • Duramed Investigational Site
    • Clearwater, Florida, United States, 33756
      • Duramed Investigational Site
    • Gainesville, Florida, United States, 32607
      • Duramed Investigational Site
    • Jacksonville, Florida, United States, 32207
      • Duramed Investigational Site
    • Leesburg, Florida, United States, 34748
      • Duramed Investigational Site
    • Miami, Florida, United States, 33143
      • Duramed Investigational Site
    • Pinellas Park, Florida, United States, 33781
      • Duramed Investigational Site
    • Stuart, Florida, United States, 34996
      • Duramed Investigational Site
    • Tampa, Florida, United States, 33607
      • Duramed Investigational Site
    • Tampa, Florida, United States, 33606
      • Duramed Investigational Site
    • Venice, Florida, United States, 34292
      • Duramed Investigational Site
    • West Palm Beach, Florida, United States, 33407
      • Duramed Investigational Site
    • West Palm Beach, Florida, United States, 33409
      • Duramed Investigational Site
    • Weston, Florida, United States, 33331
      • Duramed Investigational Site
  • Georgia
    • Alpharetta, Georgia, United States, 30005
      • Duramed Investigational Site
    • Atlanta, Georgia, United States, 30342
      • Duramed Investigational Site
    • Augusta, Georgia, United States, 30901
      • Duramed Investigational Site
    • Decatur, Georgia, United States, 30034
      • Duramed Investigational Site
    • Douglasville, Georgia, United States, 30134
      • Duramed Investigational Site
    • Sandy Springs, Georgia, United States, 30328
      • Duramed Investigational Site
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Duramed Investigational Site
    • Chicago, Illinois, United States, 60612
      • Duramed Investigational Site
  • Indiana
    • Evansville, Indiana, United States, 47714
      • Duramed Investigational Site
  • Kansas
    • Overland Park, Kansas, United States, 66215
      • Duramed Investigational Site
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • Duramed Investigational Site
    • Louisville, Kentucky, United States, 40291
      • Duramed Investigational Site
    • Madisonville, Kentucky, United States, 42431
      • Duramed Investigational Site
  • Louisiana
    • Shreveport, Louisiana, United States, 71106
      • Duramed Investigational Site
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Duramed Investigational Site
  • Michigan
    • Livonia, Michigan, United States, 48152
      • Duramed Investigational Site
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
      • Duramed Investigational Site
  • Nevada
    • Las Vegas, Nevada, United States, 89146
      • Duramed Investigational Site
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Duramed Investigational Site
  • New Jersey
    • Lawrenceville, New Jersey, United States, 08648
      • Duramed Investigational Site
    • Moorestown, New Jersey, United States, 08057
      • Duramed Investigational Site
    • New Brunswick, New Jersey, United States, 08901
      • Duramed Investigational Site
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Duramed Investigational Site
  • New York
    • Johnson City, New York, United States, 13790
      • Duramed Investigational Site
    • Williamsville, New York, United States, 14221
      • Duramed Investigational Site
  • North Carolina
    • Raleigh, North Carolina, United States, 27607
      • Duramed Investigational Site
    • Winston-Salem, North Carolina, United States, 27103
      • Duramed Investigational Site
  • North Dakota
    • Jamestown, North Dakota, United States, 58401
      • Duramed Investigational Site
    • Minot, North Dakota, United States, 58701
      • Duramed Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States, 45236
      • Duramed Investigational Site
    • Cleveland, Ohio, United States, 44122
      • Duramed Investigational Site
    • Columbus, Ohio, United States, 43213
      • Duramed Investigational Site
    • Columbus, Ohio, United States, 43205
      • Duramed Investigational Site
    • Columbus, Ohio, United States, 43212
      • Duramed Investigational Site
    • Mayfield Heights, Ohio, United States, 44124
      • Duramed Investigational Site
  • Oregon
    • Medford, Oregon, United States, 97504
      • Duramed Investigational Site
    • Portland, Oregon, United States, 97210
      • Duramed Investigational Site
    • Portland, Oregon, United States, 97239
      • Duramed Investigational Site
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18104
      • Duramed Investigational Site
    • King of Prussia, Pennsylvania, United States, 19406
      • Duramed Investigational Site
    • Media, Pennsylvania, United States, 19063
      • Duramed Investigational Site
    • Philadelphia, Pennsylvania, United States, 19114
      • Duramed Investigational Site
    • Philadelphia, Pennsylvania, United States, 19107
      • Duramed Investigational Site
    • Pittsburgh, Pennsylvania, United States, 15206
      • Duramed Investigational Site
    • Rosemont, Pennsylvania, United States, 19010
      • Duramed Investigational Site
    • Strafford, Pennsylvania, United States, 19087
      • Duramed Investigational Site
  • Rhode Island
    • Warwick, Rhode Island, United States, 02886
      • Duramed Investigational Site
  • South Carolina
    • Charleston, South Carolina, United States, 29401
      • Duramed Investigational Site
    • Charleston, South Carolina, United States, 29425-0100
      • Duramed Investigational Site
    • Columbia, South Carolina, United States, 29201
      • Duramed Investigational Site
  • South Dakota
    • Watertown, South Dakota, United States, 57201
      • Duramed Investigational Site
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • Duramed Investigational Site
    • Nashville, Tennessee, United States, 37203
      • Duramed Investigational Site
  • Texas
    • Austin, Texas, United States, 78759
      • Duramed Investigational Site
    • Austin, Texas, United States, 78748
      • Duramed Investigational Site
    • Corpus Christi, Texas, United States, 78414
      • Duramed Investigational Site
    • Dallas, Texas, United States, 75390-9032
      • Duramed Investigational Site
    • Houston, Texas, United States, 77024
      • Duramed Investigational Site
    • Houston, Texas, United States, 77074
      • Duramed Investigational Site
    • Houston, Texas, United States, 77030
      • Duramed Investigational Site
    • Houston, Texas, United States, 77015
      • Duramed Investigational Site
    • San Antonio, Texas, United States, 78229
      • Duramed Investigational Site
    • Waco, Texas, United States, 76712
      • Duramed Investigational Site
  • Vermont
    • Williston, Vermont, United States, 05495
      • Duramed Investigational Site
  • Virginia
    • Newport News, Virginia, United States, 23602
      • Duramed Investigational Site
  • Washington
    • Spokane, Washington, United States, 99207
      • Duramed Investigational Site
    • Tacoma, Washington, United States, 98405
      • Duramed Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Naturally or surgically menopausal
• 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 endometrial hyperplasia
• Recent history of vaginal bleeding of unknown cause
• Recent history or diagnosis of endometriosis
• Any contraindication to estrogen therapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: DR-2041a; 1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter; Other Names: Synthetic conjugated estrogens, A
Experimental: 2	Drug: DR-2041b; 2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter; Other Names: Synthetic conjugated estrogens, A
Placebo Comparator: 4	Other: Placebo; 1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter; Other: Placebo; 2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
Placebo Comparator: 3	Other: Placebo; 1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter; Other: Placebo; 2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in the Symptom Identified by the Patient to be Most Bothersome	Change= Week 12 score - Baseline Score. The most bothersome symptom was derived from the subject self-assessment of vaginal atrophy, which consisted of 5 questions concerning severity of symptoms graded on a scale of 0-3(none, mild, moderate or severe) or 7 for not applicable.	Baseline to Week 12
Mean Change in Vaginal pH	Change= Week 12 vaginal pH - Baseline vaginal pH	Baseline to Week 12
Mean Change in Maturation Index	Change= Week 12 maturation index -baseline maturation index. Matuation index was calculated using the following equation: Maturation Index = (% Parabasal cells * 0) + (% Intermediate Cells * 0.5) + (% Superficial Cells * 1.0)	Baseline to Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Tolerability of DR-2041 (Synthetic Conjugated Estrogens, A)	Any adverse event reported from the beginning of the 28-day screening through the subject's last report.	Up to Week 12

Collaborators and Investigators

• Sponsor: Duramed Research

Publications and helpful links

General Publications

• Freedman M, Kaunitz AM, Reape KZ, Hait H, Shu H. Twice-weekly synthetic conjugated estrogens vaginal cream for the treatment of vaginal atrophy. Menopause. 2009 Jul-Aug;16(4):735-41. doi: 10.1097/gme.0b013e318199e734.

Helpful Links

• NIH- Menopausal Hormone Therapy

Study record dates

Study Major Dates

• Study Start: August 1, 2006
• Primary Completion (Actual): September 1, 2007
• Study Completion (Actual): September 1, 2007

Study Registration Dates

• First Submitted: August 3, 2006
• First Submitted That Met QC Criteria: August 4, 2006
• First Posted (Estimate): August 8, 2006

Study Record Updates

• Last Update Posted (Estimate): April 20, 2015
• Last Update Submitted That Met QC Criteria: March 30, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: vaginal dryness; vaginal atrophy; vaginal pain; vaginal itching
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Estrogens; Estrogens, Conjugated (USP); Estrogens, conjugated synthetic A
• Other Study ID Numbers: DR-CEN-302