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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levonorgestrel/EE 0.15/0.03 mg and EE 0.01 mg tablets | Drug | 1 tablet daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient and Investigator reports of adverse events | Duration of Study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Duramed Protocol Chair | Duramed Research, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duramed Investigational Site | Tucson | Arizona | 85715 | United States | ||
| Duramed Investigational Site |
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| Washington D.C. |
| District of Columbia |
| 20006 |
| United States |
| Duramed Investigational Site | Lincoln | Nebraska | 68510 | United States |
| Duramed Investigational Site | Rochester | New York | 14609 | United States |
| Duramed Investigational Site | Charlotte | North Carolina | 28209 | United States |
| Duramed Investigational Site | Winston-Salem | North Carolina | 27103 | United States |
| Duramed Investigational Site | Columbus | Ohio | 43213 | United States |
| Duramed Investigational Site | Oklahoma City | Oklahoma | 73112 | United States |
| Duramed Investigational Site | Nashville | Tennessee | 37203 | United States |
| Duramed Investigational Site | Arlington | Virginia | 22203 | United States |
| Duramed Investigational Site | Norfolk | Virginia | 23507 | United States |
| ID | Term |
|---|---|
| C000606708 | Seasonique |
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