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| ID | Type | Description | Link |
|---|---|---|---|
| B3211019, B3211020, B3211022 | Other Identifier | Pfizer |
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To evaluate the safety and contraceptive efficacy of an oral contraceptive containing a combination of LNG 90 mg/EE 20 mg in a continuous-use regimen.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levonorgestrel 90 mg/Ethinyl Estradiol 20 mg | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate safety and contraceptive efficacy |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the effects of this LNG/EE combination on bleeding profile, endometrial histology, hemostasis measures, hemoglobin levels, discontinuation rates, subject satisfaction, and cycle-related symptoms and work productivity at baseline. |
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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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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21074011 | Derived | Reid RL, Fortier MP, Smith L, Mirkin S, Grubb GS, Constantine GD. Safety and bleeding profile of continuous levonorgestrel 90 mcg/ethinyl estradiol 20 mcg based on 2 years of clinical trial data in Canada. Contraception. 2010 Dec;82(6):497-502. doi: 10.1016/j.contraception.2010.06.002. Epub 2010 Jul 16. |
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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 |