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This is a randomized, open-label study to evaluate pituitary ovarian suppression in healthy, reproductive-aged women using three different regimens of oral contraceptives (OCs). Two extended regimen OCs, Seasonale (levonorgestrel/ethinyl estradiol 0.15/0.03 mg for 84 days followed by 7 days of placebo), and Seasonique (levonorgestrel/ethinyl estradiol 0.15/0.03 mg for 84 days followed by 7 days of ethinyl estradiol 0.01 mg), and a 28-day regimen OC, Portia (levonorgestrel/ethinyl estradiol 0.15/0.03 mg for 21 days followed by 7 days of placebo).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
| |
| 3 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Seasonale [levonorgestrel (LNG)/ethinyl estradiol (EE)] | Drug | 1 tablet daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Compare differences in hormone patterns (follicle stimulating hormone [FSH], luteinizing hormone [LH], inhibin-B, and estradiol) | Before, during and after the 7-day hormone free interval or EE-supplemented interval |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the differences in hormone withdrawal symptoms | Before, during and after the 7-day hormone free interval or EE-supplemented interval | |
| Compare differences in ovarian follicular development | Before, during and after the 7-day hormone free interval or EE-supplemented intervals |
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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 | Temple | Texas | 76508 | United States |
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| Seasonique (LNG/EE and EE) |
| Drug |
1 tablet daily |
|
| Portia (LNG/EE) | Drug | 1 tablet daily x 28 days |
|
| ID | Term |
|---|---|
| C482584 | Seasonale |
| D016912 | Levonorgestrel |
| C000606708 | Seasonique |
| D019304 | Ethinyl Estradiol-Norgestrel Combination |
| ID | Term |
|---|---|
| D009644 | Norgestrel |
| D009652 | Norpregnenes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004997 | Ethinyl Estradiol |
| D009651 | Norpregnatrienes |
| 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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