Study Evaluating Levonorgestrel and Ethinyl Estradiol in Oral Contraception

A Multicenter, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Levonorgestrel 90 Mg and Ethinyl Estradiol 20 Mg in a Continuous 28-Day Regimen for Oral Contraception Versus a Cyclic 21-Day Regimen Oral Contraceptive

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00248963

Enrollment

600

Registered

2005-11-04

Start date

Unknown

Completion date

2004-10-31

Last updated

2006-05-19

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

Conditions

Oral Contraceptive

Keywords

Oral Contraceptive

Brief summary

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.

Interventions

DRUGLevonorgestrel 90 mg and Ethinyl Estradiol 20 mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

ECT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 49 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy women aged 18 to 49 years who are willing to rely upon a combination birth control pill as their only method of contraception. * Women must be sexually active and at risk for becoming pregnant. * Women must have had regular (21- to 35- day) menstrual cycles for the 3-month period preceding study visit 1.

Exclusion criteria

* High blood pressure * Age greater then 34 and smoking more than 15 cigarettes per day. * Depression requiring hospitalization or associated with suicidal ideation within the last 3 years.

Design outcomes

Primary

Measure	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	—

Secondary

Measure	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	—

Outcome results

None listed

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