Study Evaluating Levonorgestrel/Ethinyl Estradiol (LNG/EE) in PMS

NCT ID: NCT00161681

Last Updated: 2013-02-08

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

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2006-08-31

Brief Summary

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The purpose of this study is to determine whether LNG/EE is effective in the treatment of menstrual cycle related symptoms.

Detailed Description

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Conditions

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Premenstrual Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Levonorgestrel/Ethinyl Estradiol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy women aged 18 to 49 years
* Regular 21 to 35 day menstrual cycles for 3 months prior to study visit 1
* History of menstrual cycle related symptoms as determined by the investigator.

Exclusion Criteria

* Contraindication to combination oral contraceptives
* Depression requiring hospitalization or associated with suicidal ideation within the last 3 years
* Use of antidepressants/anxiolytics within 10 days of screening and for the duration of the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor, MD

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Locations

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Huntsville, Alabama, United States

Site Status

Peoria, Arizona, United States

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Phoenix, Arizona, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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San Diego, California, United States

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Denver, Colorado, United States

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Longmont, Colorado, United States

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Aventura, Florida, United States

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Boynton Beach, Florida, United States

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Clearwater, Florida, United States

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DeLand, Florida, United States

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Fort Myers, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Pembroke Pines, Florida, United States

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Tampa, Florida, United States

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West Palm Beach, Florida, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Savannah, Georgia, United States

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Idaho Falls, Idaho, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Lexington, Kentucky, United States

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Kansas City, Missouri, United States

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Las Vegas, Nevada, United States

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Las Vegas, Nevada, United States

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Moorestown, New Jersey, United States

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Rochester, New York, United States

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Fayetteville, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cleveland, Ohio, United States

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Mogadore, Ohio, United States

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Eugene, Oregon, United States

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Medford, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Wexford, Pennsylvania, United States

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Hilton Head Island, South Carolina, United States

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Mt. Pleasant, South Carolina, United States

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Nashville, Tennessee, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Sandy City, Utah, United States

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Richmond, Virginia, United States

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Lakewood, Washington, United States

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Seattle, Washington, United States

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Countries

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United States

Other Identifiers

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B3121024

Identifier Type: OTHER

Identifier Source: secondary_id

0858A2-322

Identifier Type: -

Identifier Source: org_study_id

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