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OpenTrials
Completed

NCT Number: NCT00196352

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

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.

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Key information

Conditions

Contraception

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Duramed Investigational Site, Tucson, Arizona, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participant in the earlier Phase 3 Seasonique clinical trial

Exclusion criteria

  • Any contraindication to the use of oral contraceptives

Treatment and study plan

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

Drug

1 tablet daily

Other names: Seasonique

Primary outcomes

  1. Patient and Investigator reports of adverse events

    Time frame: Duration of Study

Sponsors and collaborators

Lead sponsor

Duramed Research

Industry

Registry information

Official study title

A Prospective, Multiple Site Study to Evaluate the Safety of an Extended Cycle Combination Oral Contraceptive, Seasonique, Which Utilizes Ethinyl Estradiol During the Pill-free Interval.

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Sep 20, 2005
Registry last updated
Apr 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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