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To evaluate the contraceptive efficacy of an oral contraceptive containing a combination of LNG 90 mg/EE 20 mg in a continuous-use regimen and to evaluate the safety compared to LNG 100 mg/EE 20 mg for 21 days followed by a 7-day hormone-free interval in a cyclic regimen.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levonorgestrel 90 mg and Ethinyl Estradiol 20 mg | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the contraceptive efficacy of an OC containing a combination of LNG 90 mg/EE 20 mg in a continuous-use regimen and the safety compared to LNG 100 mg/EE 20 mg for 21 days followed by a 7-day hormone-free interval in a cyclic regimen |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the effects on vaginal bleeding profile, hemostatic balance, lipid, carbohydrate, bone metabolism measures, hemoglobin levels, discontinuation rates, compliance with respect to pill taking, subject satisfaction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer | Study Director |
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| ID | Term |
|---|---|
| D016912 | Levonorgestrel |
| D004997 | Ethinyl Estradiol |
| ID | Term |
|---|---|
| D009644 | Norgestrel |
| D009652 | Norpregnenes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 |
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| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| 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 |