NCT00196352

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
320

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2003

Typical duration for phase_3

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

April 8, 2014

Status Verified

April 1, 2014

Enrollment Period

3.5 years

First QC Date

September 12, 2005

Last Update Submit

April 7, 2014

Conditions

Contraception

Keywords

oral contraceptivesbirth controlethinyl estradiolpregnancy prevention

Outcome Measures

Primary Outcomes (1)

  • Patient and Investigator reports of adverse events

    Duration of Study

Study Arms (1)

1

EXPERIMENTAL
Drug: Levonorgestrel/EE 0.15/0.03 mg and EE 0.01 mg tablets

Interventions

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

1 tablet daily

Also known as: Seasonique
1

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Participant in the earlier Phase 3 Seasonique clinical trial

You may not qualify if:

  • Any contraindication to the use of oral contraceptives

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Duramed Investigational Site

Tucson, Arizona, 85715, United States

Location

Duramed Investigational Site

Washington D.C., District of Columbia, 20006, United States

Location

Duramed Investigational Site

Lincoln, Nebraska, 68510, United States

Location

Duramed Investigational Site

Rochester, New York, 14609, United States

Location

Duramed Investigational Site

Charlotte, North Carolina, 28209, United States

Location

Duramed Investigational Site

Winston-Salem, North Carolina, 27103, United States

Location

Duramed Investigational Site

Columbus, Ohio, 43213, United States

Location

Duramed Investigational Site

Oklahoma City, Oklahoma, 73112, United States

Location

Duramed Investigational Site

Nashville, Tennessee, 37203, United States

Location

Duramed Investigational Site

Arlington, Virginia, 22203, United States

Location

Duramed Investigational Site

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Interventions

Seasonique

Study Officials

  • Duramed Protocol Chair

    Duramed Research, Inc.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

May 1, 2003

Primary Completion

November 1, 2006

Study Completion

November 1, 2006

Last Updated

April 8, 2014

Record last verified: 2014-04

Locations

US(11)