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

Phase 3CompletedNCT00196352

Duramed Research320 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

320

Conditions

Contraception

Interventions

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

1 tablet daily

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Participant in the earlier Phase 3 Seasonique clinical trial Exclusion Criteria: * Any contraindication to the use of oral contraceptives

Locations (11)

Duramed Investigational Site

Tucson, Arizona, United States

Duramed Investigational Site

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

Duramed Investigational Site

Lincoln, Nebraska, United States

Outcomes

Primary Outcomes

Patient and Investigator reports of adverse events

Time frame: Duration of Study

Data from ClinicalTrials.gov

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