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This study is being conducted to evaluate the effects of treatment with Seasonique an extended-regimen oral contraceptive that utilizes low dose ethinyl estradiol during the typical hormone-free interval. Patients will receive 26 weeks of treatment. The overall study duration will be approximately 9 months. Patients will be required to record menstrual pain in a daily diary.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets | Drug | 1 tablet daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the clinical assessment of dysmenorrhea | Baseline to Week 4,8,12,24, and 26 or early discontinuation |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in clinical assessment of dysmenorrhea (assessment of 4 additional symptoms) | Baseline to Weeks 4, 8, 12, 24 and 26 or early discontinuation | |
| Incidence of menstrual bleeding and/or spotting | 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 | Huntsville | Alabama | 35801 | United States | ||
| Duramed Investigational Site |
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| levonorgestrel/EE 0.15/0.03 mg tablets and placebo | Drug | 1 tablet daily |
|
|
| Analgesic use | Duration of study |
| Phoenix |
| Arizona |
| 85032 |
| United States |
| Duramed Investigational Site | San Diego | California | 92108 | United States |
| Duramed Investigational Site | Denver | Colorado | 80202 | United States |
| Duramed Investigational Site | Tampa | Florida | 33607 | United States |
| Duramed Investigational Site | Decatur | Georgia | 30034 | United States |
| Duramed Investigational Site | Moorestown | New Jersey | 08057 | United States |
| Duramed Investigational Site | Charlotte | North Carolina | 28222 | United States |
| Duramed Investigational Site | Columbus | Ohio | 43205 | United States |
| Duramed Investigational Site | Columbus | Ohio | 43213 | United States |
| Duramed Investigational Site | Medford | Oregon | 97504 | United States |
| Duramed Investigational Site | Philadelphia | Pennsylvania | 19114 | United States |
| Duramed Investigational Site | Memphis | Tennessee | 38120 | United States |
| Duramed Investigational Site | Salt Lake City | Utah | 84124 | United States |
| Duramed Investigational Site | Newport News | Virginia | 23602 | United States |
| Duramed Investigational Site | Norfolk | Virginia | 23507 | United States |
| Duramed Investigational Site | Spokane | Washington | 99207 | United States |
| Duramed Investigational Site | Tacoma | Washington | 98405 | United States |
| ID | Term |
|---|---|
| D004412 | Dysmenorrhea |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017699 | Pelvic Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C000606708 | Seasonique |
| D019304 | Ethinyl Estradiol-Norgestrel Combination |
| ID | Term |
|---|---|
| D004997 | Ethinyl Estradiol |
| D009651 | Norpregnatrienes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D009644 | Norgestrel |
| D009652 | Norpregnenes |
| D042782 | Estrogenic Steroids, Alkylated |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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