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

Phase 3

Completed

• Conditions: Contraception
• Interventions: Drug: Levonorgestrel/EE 0.15/0.03 mg and EE 0.01 mg tablets

• Registration Number: NCT00196352
• Lead Sponsor: Duramed Research

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.

Study Timeline

• Study Start: 2003-05
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-20
• Primary Completion: 2006-11
• Study Completion: 2006-11
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-07
• Last Update Posted: 2014-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 320

Inclusion Criteria

• Participant in the earlier Phase 3 Seasonique clinical trial

Exclusion Criteria

• Any contraindication to the use of oral contraceptives

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Levonorgestrel/EE 0.15/0.03 mg and EE 0.01 mg tablets	-

Primary Outcome Measures

Name	Time	Method
Patient and Investigator reports of adverse events	Duration of Study

Trial Locations

Locations (1)

Duramed Investigational Site; 🇺🇸 Norfolk, Virginia, United States