A Study to Evaluate the Efficacy of Seasonique for the Treatment of Cyclic Pelvic Pain

NCT ID: NCT00196365

Last Updated: 2014-05-12

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

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2007-07-31

Brief Summary

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This study is being conducted to evaluate the effects of treatment with Seasonique an extended-regimen oral contraceptive that utilizes low dose ethinyl estradiol during the typical hormone-free interval. Patients will receive 26 weeks of treatment. The overall study duration will be approximately 9 months. Patients will be required to record menstrual pain in a daily diary.

Detailed Description

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Conditions

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Dysmenorrhea

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

levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets

Intervention Type DRUG

1 tablet daily

2

Group Type ACTIVE_COMPARATOR

levonorgestrel/EE 0.15/0.03 mg tablets and placebo

Intervention Type DRUG

1 tablet daily

Interventions

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levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets

1 tablet daily

Intervention Type DRUG

levonorgestrel/EE 0.15/0.03 mg tablets and placebo

1 tablet daily

Intervention Type DRUG

Other Intervention Names

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Seasonique Portia

Eligibility Criteria

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Inclusion Criteria

* Moderate to severe menstrual-related pain
* Regular spontaneous menstrual cycles

Exclusion Criteria

* Any contraindication to the use of oral contraceptives
* Treatment with an oral contraceptive in the last 3 months
* Previous treatment failure with an extended oral contraceptive regimen
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 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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Duramed Protocol Chair

Role: STUDY_CHAIR

Duramed Research, Inc.

Locations

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Duramed Investigational Site

Huntsville, Alabama, United States

Site Status

Duramed Investigational Site

Phoenix, Arizona, United States

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San Diego, California, United States

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Denver, Colorado, United States

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Tampa, Florida, United States

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Decatur, Georgia, United States

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Duramed Investigational Site

Moorestown, New Jersey, United States

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Duramed Investigational Site

Charlotte, North Carolina, United States

Site Status

Duramed Investigational Site

Columbus, Ohio, United States

Site Status

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Columbus, Ohio, United States

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Medford, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Memphis, Tennessee, United States

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Salt Lake City, Utah, United States

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Newport News, Virginia, United States

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Duramed Investigational Site

Norfolk, Virginia, United States

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Duramed Investigational Site

Spokane, Washington, United States

Site Status

Duramed Investigational Site

Tacoma, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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DR-PSE-305

Identifier Type: -

Identifier Source: org_study_id

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