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

Sponsor

Duramed Research (Industry)

Overall Status

Completed

CT.gov ID

NCT00196352

Collaborator

(none)

320

Enrollment

Locations

Arm

42.1

Duration (Months)

29.1

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Contraception	Drug: Levonorgestrel/EE 0.15/0.03 mg and EE 0.01 mg tablets	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

320 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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.

Study Start Date :

May 1, 2003

Actual Primary Completion Date :

Nov 1, 2006

Actual Study Completion Date :

Nov 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: Levonorgestrel/EE 0.15/0.03 mg and EE 0.01 mg tablets 1 tablet daily Other Names: Seasonique

Arm

Intervention/Treatment

Experimental: 1

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

1 tablet daily

Other Names:

Seasonique

Outcome Measures

Primary Outcome Measures

Patient and Investigator reports of adverse events [Duration of Study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Participant in the earlier Phase 3 Seasonique clinical trial

Exclusion Criteria:

Any contraindication to the use of oral contraceptives

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duramed Investigational Site	Tucson	Arizona	United States	85715
2	Duramed Investigational Site	Washington	District of Columbia	United States	20006
3	Duramed Investigational Site	Lincoln	Nebraska	United States	68510
4	Duramed Investigational Site	Rochester	New York	United States	14609
5	Duramed Investigational Site	Charlotte	North Carolina	United States	28209
6	Duramed Investigational Site	Winston-Salem	North Carolina	United States	27103
7	Duramed Investigational Site	Columbus	Ohio	United States	43213
8	Duramed Investigational Site	Oklahoma City	Oklahoma	United States	73112
9	Duramed Investigational Site	Nashville	Tennessee	United States	37203
10	Duramed Investigational Site	Arlington	Virginia	United States	22203
11	Duramed Investigational Site	Norfolk	Virginia	United States	23507