Study Evaluating Levonorgestrel and Ethinyl Estradiol in Oral Contraception

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2004-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Oral Contraceptive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

ECT

Blinding Strategy

NONE

Interventions

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Levonorgestrel 90 mg and Ethinyl Estradiol 20 mg

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Other Identifiers

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0858A2-315

Identifier Type: -

Identifier Source: org_study_id