Study Evaluating Levonorgestrel and Ethinyl Estradiol for Oral Contraception

A Phase 3, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of Levonorgestrel 90 mg and Ethinyl Estradiol 20 mg in a Continuous Daily Regimen for Oral Contraception

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00245921

Enrollment

2000

Registered

2005-10-28

Start date

2003-02-28

Completion date

2005-10-31

Last updated

2013-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception

Keywords

contraception

Brief summary

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.

Interventions

DRUGLevonorgestrel 90 mg/Ethinyl Estradiol 20 mg

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 49 Years

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).

Design outcomes

Primary

Measure	Time frame
To evaluate safety and contraceptive efficacy	—

Secondary

Measure	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.	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026