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

Contraception Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00196352
• Other study ID #: PSE-304
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: April 7, 2014
• Start date: May 2003
• Est. completion date: November 2006

Study information

• Verified date: April 2014
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Participant in the earlier Phase 3 Seasonique clinical trial

Exclusion Criteria:

• Any contraindication to the use of oral contraceptives

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• Levonorgestrel/EE 0.15/0.03 mg and EE 0.01 mg tablets
1 tablet daily

Locations

Country	Name	City	State
United States	Duramed Investigational Site	Arlington	Virginia
United States	Duramed Investigational Site	Charlotte	North Carolina
United States	Duramed Investigational Site	Columbus	Ohio
United States	Duramed Investigational Site	Lincoln	Nebraska
United States	Duramed Investigational Site	Nashville	Tennessee
United States	Duramed Investigational Site	Norfolk	Virginia
United States	Duramed Investigational Site	Oklahoma City	Oklahoma
United States	Duramed Investigational Site	Rochester	New York
United States	Duramed Investigational Site	Tucson	Arizona
United States	Duramed Investigational Site	Washington	District of Columbia
United States	Duramed Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duramed Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient and Investigator reports of adverse events		Duration of Study	Yes