NCT00196352

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 320 (actual)
• Sponsor: Duramed Research · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Contraception

Interventions

Type	Name	Description
DRUG	Levonorgestrel/EE 0.15/0.03 mg and EE 0.01 mg tablets	1 tablet daily

Timeline

• Start date: 2003-05-01
• Primary completion: 2006-11-01
• Completion: 2006-11-01
• First posted: 2005-09-20
• Last updated: 2014-04-08

Locations

11 sites across 1 country: United States