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

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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00196352

Enrollment

320

Registered

2005-09-20

Start date

2003-05-31

Completion date

2006-11-30

Last updated

2014-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception

Keywords

oral contraceptives, birth control, ethinyl estradiol, pregnancy prevention

Brief summary

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

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.

Interventions

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

1 tablet daily

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

* Participant in the earlier Phase 3 Seasonique clinical trial

Exclusion criteria

* Any contraindication to the use of oral contraceptives

Design outcomes

Primary

Measure	Time frame
Patient and Investigator reports of adverse events	Duration of Study

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026