search
Back to results

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

Primary Purpose

Menopause

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
DR-2041a
DR-2041b
Placebo
Placebo
Sponsored by
Duramed Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Menopause focused on measuring vaginal atrophy, vaginal dryness, vaginal itching, vaginal pain

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

1

2

3

4

Arm Description

Outcomes

Primary Outcome Measures

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.
Mean Change in Vaginal pH
Change= Week 12 vaginal pH - Baseline vaginal pH
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)

Secondary Outcome Measures

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.

Full Information

First Posted
August 3, 2006
Last Updated
March 30, 2015
Sponsor
Duramed Research
search

1. Study Identification

Unique Protocol Identification Number
NCT00361569
Brief Title
A Clinical Trial to Evaluate the Safety and Efficacy of DR-2041(Synthetic Conjugated Estrogens, A) for Treatment of Vulvovaginal Atrophy
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Duramed Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menopause
Keywords
vaginal atrophy, vaginal dryness, vaginal itching, vaginal pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
622 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Placebo Comparator
Arm Title
4
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
DR-2041a
Other Intervention Name(s)
Synthetic conjugated estrogens, A
Intervention Description
1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
Intervention Type
Drug
Intervention Name(s)
DR-2041b
Other Intervention Name(s)
Synthetic conjugated estrogens, A
Intervention Description
2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
Primary Outcome Measure Information:
Title
Mean Change in the Symptom Identified by the Patient to be Most Bothersome
Description
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.
Time Frame
Baseline to Week 12
Title
Mean Change in Vaginal pH
Description
Change= Week 12 vaginal pH - Baseline vaginal pH
Time Frame
Baseline to Week 12
Title
Mean Change in Maturation Index
Description
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)
Time Frame
Baseline to Week 12
Secondary Outcome Measure Information:
Title
Safety and Tolerability of DR-2041 (Synthetic Conjugated Estrogens, A)
Description
Any adverse event reported from the beginning of the 28-day screening through the subject's last report.
Time Frame
Up to Week 12

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
19252451
Citation
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.
Results Reference
result
Links:
URL
http://www.menopause.org/edumaterials/guidebook/guidebook.aspx
Description
NAMS- Menopause Guidebook

Learn more about this trial

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

We'll reach out to this number within 24 hrs