A Multicenter Study to Evaluate the Safety of Seasonique, an Oral Contraceptive.

NCT ID: NCT00196352

Last Updated: 2014-04-08

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

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Study Completion Date

2006-11-30

Brief Summary

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This study is being conducted to evaluate the safety of ethinyl an extended-regimen oral contraceptive, with ethinyl estradiol supplementation during the usual hormone-free week, for up to an additional three consecutive years.

Detailed Description

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This study is being conducted to evaluate the safety of an extended-regimen oral contraceptive, with ethinyl estradiol supplementation during the usual hormone-free week, for up to an additional three consecutive years. This is an extension of the Seasonique Phase 3 clinical trial to evaluate long-term safety. Only patients enrolled in the earlier trial are eligible for participation.

Conditions

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Contraception

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Levonorgestrel/EE 0.15/0.03 mg and EE 0.01 mg tablets

Intervention Type DRUG

1 tablet daily

Interventions

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Levonorgestrel/EE 0.15/0.03 mg and EE 0.01 mg tablets

1 tablet daily

Intervention Type DRUG

Other Intervention Names

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Seasonique

Eligibility Criteria

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Inclusion Criteria

* Participant in the earlier Phase 3 Seasonique clinical trial

Exclusion Criteria

* Any contraindication to the use of oral contraceptives
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

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

Tucson, Arizona, United States

Site Status

Duramed Investigational Site

Washington D.C., District of Columbia, United States

Site Status

Duramed Investigational Site

Lincoln, Nebraska, United States

Site Status

Duramed Investigational Site

Rochester, New York, United States

Site Status

Duramed Investigational Site

Charlotte, North Carolina, United States

Site Status

Duramed Investigational Site

Winston-Salem, North Carolina, United States

Site Status

Duramed Investigational Site

Columbus, Ohio, United States

Site Status

Duramed Investigational Site

Oklahoma City, Oklahoma, United States

Site Status

Duramed Investigational Site

Nashville, Tennessee, United States

Site Status

Duramed Investigational Site

Arlington, Virginia, United States

Site Status

Duramed Investigational Site

Norfolk, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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PSE-304

Identifier Type: -

Identifier Source: org_study_id

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