Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To determine the ability of a monophasic oral contraceptives ("OC") regimen of Levonorgestrel ("LNG") 90 mg and Ethinyl Estradiol ("EE") 20 mg to inhibit ovulation during 84 days of continuous therapy.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levonorgestrel | Drug | |||
| Ethinyl Estradiol | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the ability of a monophasic oral contraceptive (OC) regimen of Levonorgestrel 90 mg and Ethinyl Estradiol 20 mg to inhibit ovulation during 84 days of continuous therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety profile. To assess the ovarian activity, as measured by the Hoogland and Skouby 6-point grading system, during 84 days of continuous therapy. To evaluate the time to return of ovulation after cessation of treatment. |
Not provided
Inclusion Criteria:
Other inclusions apply.
Exclusion Criteria:
A history or the presence of any of the following will prevent enrollment:
Other exclusions apply.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19698816 | Derived | Archer DF, Kovalevsky G, Ballagh SA, Grubb GS. Ovarian activity and safety of a novel levonorgestrel/ethinyl estradiol continuous oral contraceptive regimen. Contraception. 2009 Sep;80(3):245-53. doi: 10.1016/j.contraception.2009.03.006. Epub 2009 May 2. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D016912 | Levonorgestrel |
| D004997 | Ethinyl Estradiol |
| ID | Term |
|---|---|
| D009644 | Norgestrel |
| D009652 | Norpregnenes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |