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

NCT ID: NCT00196378

Last Updated: 2013-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2006-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Menopause

Keywords

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vaginal atrophy vaginal dryness vaginal itching vaginal pain dyspareunia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

Synthetic Conjugated estrogens, B

Intervention Type DRUG

1 (0.3mg) tablet daily

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

1 tablet daily

Interventions

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Synthetic Conjugated estrogens, B

1 (0.3mg) tablet daily

Intervention Type DRUG

Placebo

1 tablet daily

Intervention Type OTHER

Other Intervention Names

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Enjuvia

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Duramed Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Duramed Research, Inc.

Principal Investigators

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Duraemd Protocol Chair

Role: STUDY_CHAIR

Duramed Research, Inc.

Locations

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Duramed Investigational Site

Huntsville, Alabama, United States

Site Status

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Tucson, Arizona, United States

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Carmichael, California, United States

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San Diego, California, United States

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San Diego, California, United States

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Colorado Springs, Colorado, United States

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Denver, Colorado, United States

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Gainesville, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Sarasota, Florida, United States

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Venice, Florida, United States

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Alpharetta, Georgia, United States

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Boise, Idaho, United States

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Evansville, Indiana, United States

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Baton Rouge, Louisiana, United States

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Laurel, Maryland, United States

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Billings, Montana, United States

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Las Vegas, Nevada, United States

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Las Vegas, Nevada, United States

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Las Vegas, Nevada, United States

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Winston-Salem, North Carolina, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Mayfield Heights, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Medford, Oregon, United States

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Pittsburgh, Pennsylvania, United States

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Columbia, South Carolina, United States

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Clarksville, Tennessee, United States

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Memphis, Tennessee, United States

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Fort Worth, Texas, United States

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San Antonio, Texas, United States

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Sugarland, Texas, United States

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Newport News, Virginia, United States

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Norfolk, Virginia, United States

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Spokane, Washington, United States

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Tacoma, Washington, United States

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Countries

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United States

References

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Simon JA, Reape KZ, Wininger S, Hait H. Randomized, multicenter, double-blind, placebo-controlled trial to evaluate the efficacy and safety of synthetic conjugated estrogens B for the treatment of vulvovaginal atrophy in healthy postmenopausal women. Fertil Steril. 2008 Oct;90(4):1132-8. doi: 10.1016/j.fertnstert.2007.07.1359. Epub 2007 Dec 3.

Reference Type DERIVED
PMID: 18053998 (View on PubMed)

Other Identifiers

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DR-ENJ-301

Identifier Type: -

Identifier Source: org_study_id