Study Evaluating Levonorgestrel and Ethinyl Estradiol for Oral Contraception

Wyeth

Status and phase: Completed; Phase 3

Conditions: Contraception

Treatments: Drug: Levonorgestrel 90 mg/Ethinyl Estradiol 20 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00245921

0858A2-313, 314, 320

B3211019, B3211020, B3211022 (Other Identifier)

Details and patient eligibility

About

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.

Sex: Female

Ages: 18 to 49 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Healthy women aged 18 to 49 years
• Regular (21- to 35- day) menstrual cycles for the 3-month period preceding visit 1
• Must be sexually active and at risk for becoming pregnant.

Exclusion criteria

• Planned use of any other form of birth control other than the test article.
• Depression requiring hospitalization or associated with suicidal ideation within the last 3 years.
• High blood pressure (defined as elevated sitting blood pressure: > 140/90 mm Hg).