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

NCT00361569 | Completed Phase 3 Results

• 1 other identifier: DR-CEN-302
• Study Type: interventional
• Target: 622
• Locations: 1 country
• Sites: 97

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.

Conditions

Menopause

Keywords

vaginal atrophy; vaginal dryness; vaginal itching; vaginal pain

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Safety and Tolerability of DR-2041 (Synthetic Conjugated Estrogens, A)

  Up to Week 12

Study Arms (4)

1

EXPERIMENTAL

Drug: DR-2041a

2

EXPERIMENTAL

Drug: DR-2041b

3

PLACEBO COMPARATOR

Other: Placebo

4

PLACEBO COMPARATOR

Other: Placebo

Interventions

DR-2041a DRUG

1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter

Also known as: Synthetic conjugated estrogens, A

1

DR-2041b DRUG

2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter

Also known as: Synthetic conjugated estrogens, A

2

Placebo OTHER

1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter

3

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Naturally or surgically menopausal
• Moderate or severe symptoms of vaginal atrophy (ie, dryness, itching, pain, uncomfortable intercourse)

You may not qualify if:

• 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

Sponsors & Collaborators

• Duramed Research: lead

Study Sites (97)

Duramed Investigational Site

Huntsville, Alabama, 35801, United States

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Mobile, Alabama, 36608, United States

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Montgomery, Alabama, 36608, United States

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Phoenix, Arizona, 85015, United States

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Phoenix, Arizona, 85031, United States

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Phoenix, Arizona, 85032, United States

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Tucson, Arizona, 85710, United States

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Carmichael, California, 95608, United States

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Fresno, California, 93710, United States

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San Diego, California, 92103, United States

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San Diego, California, 92108, United States

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San Diego, California, 92123, United States

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San Ramon, California, 94583, United States

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Colorado Springs, Colorado, 80909, United States

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Pueblo, Colorado, 81001, United States

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New London, Connecticut, 06320, United States

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Clearwater, Florida, 33756, United States

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Clearwater, Florida, 33759, United States

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Gainesville, Florida, 32607, United States

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Jacksonville, Florida, 32207, United States

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Leesburg, Florida, 34748, United States

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Miami, Florida, 33143, United States

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Pinellas Park, Florida, 33781, United States

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Stuart, Florida, 34996, United States

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Tampa, Florida, 33606, United States

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Tampa, Florida, 33607, United States

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Venice, Florida, 34292, United States

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West Palm Beach, Florida, 33407, United States

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West Palm Beach, Florida, 33409, United States

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Weston, Florida, 33331, United States

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Alpharetta, Georgia, 30005, United States

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Atlanta, Georgia, 30342, United States

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Augusta, Georgia, 30901, United States

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Decatur, Georgia, 30034, United States

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Douglasville, Georgia, 30134, United States

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Sandy Springs, Georgia, 30328, United States

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Chicago, Illinois, 60611, United States

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Chicago, Illinois, 60612, United States

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Evansville, Indiana, 47714, United States

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Overland Park, Kansas, 66215, United States

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Lexington, Kentucky, 40509, United States

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Louisville, Kentucky, 40291, United States

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Madisonville, Kentucky, 42431, United States

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Shreveport, Louisiana, 71106, United States

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Baltimore, Maryland, 21224, United States

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Livonia, Michigan, 48152, United States

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Lincoln, Nebraska, 68510, United States

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Las Vegas, Nevada, 89146, United States

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Lebanon, New Hampshire, 03756, United States

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Lawrenceville, New Jersey, 08648, United States

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Moorestown, New Jersey, 08057, United States

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New Brunswick, New Jersey, 08901, United States

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Albuquerque, New Mexico, 87102, United States

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Johnson City, New York, 13790, United States

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Williamsville, New York, 14221, United States

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Raleigh, North Carolina, 27607, United States

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Winston-Salem, North Carolina, 27103, United States

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Jamestown, North Dakota, 58401, United States

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Minot, North Dakota, 58701, United States

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Cincinnati, Ohio, 45236, United States

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Cleveland, Ohio, 44122, United States

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Columbus, Ohio, 43205, United States

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Columbus, Ohio, 43212, United States

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Columbus, Ohio, 43213, United States

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Mayfield Heights, Ohio, 44124, United States

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Medford, Oregon, 97504, United States

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Portland, Oregon, 97210, United States

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Portland, Oregon, 97239, United States

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Allentown, Pennsylvania, 18104, United States

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King of Prussia, Pennsylvania, 19406, United States

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Media, Pennsylvania, 19063, United States

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Philadelphia, Pennsylvania, 19107, United States

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Philadelphia, Pennsylvania, 19114, United States

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Pittsburgh, Pennsylvania, 15206, United States

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Rosemont, Pennsylvania, 19010, United States

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Strafford, Pennsylvania, 19087, United States

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Warwick, Rhode Island, 02886, United States

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Charleston, South Carolina, 29401, United States

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Charleston, South Carolina, 29425-0100, United States

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Columbia, South Carolina, 29201, United States

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Watertown, South Dakota, 57201, United States

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Memphis, Tennessee, 38120, United States

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Nashville, Tennessee, 37203, United States

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Austin, Texas, 78748, United States

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Austin, Texas, 78759, United States

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Corpus Christi, Texas, 78414, United States

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Dallas, Texas, 75390-9032, United States

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Houston, Texas, 77015, United States

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Houston, Texas, 77024, United States

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Houston, Texas, 77030, United States

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Houston, Texas, 77074, United States

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San Antonio, Texas, 78229, United States

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Waco, Texas, 76712, United States

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Williston, Vermont, 05495, United States

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Newport News, Virginia, 23602, United States

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Spokane, Washington, 99207, United States

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Tacoma, Washington, 98405, United States

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Related Publications (1)

• 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.

  PMID: 19252451 RESULT

MeSH Terms

Interventions

estrogens, conjugated synthetic A

Results Point of Contact

• Title: Duramed Research Protocol Chair
• Organization: Duramed Research

medicalaffairs@barrlabs.com

215-293-7279

Study Officials

• Duramed Protocol Chair

  Duramed Research, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 3, 2006
• First Posted: August 8, 2006
• Study Start: August 1, 2006
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: April 20, 2015
• Results First Posted: April 14, 2009

Record last verified: 2015-03

Locations

US (97)