Study Evaluating Levonorgestrel and Ethinyl Estradiol for Oral Contraception

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the contraceptive efficacy and safety of an oral contraceptive containing a combination of LNG 100mcg/EE 20mcg compared to LNG 150mcg/EE 30 mcg.

Official Title
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A Multicenter, Randomized, Open-labe, Controlled Study to Evaluate the Efficacy and Safety of the Combined Levonorgestrel(LNG) 100mcg and Ethinyl Estradiol(EE) 20mcg for Oral Contraception

Conditions
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Oral Contraceptive

Intervention / Treatment
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* Drug: Levonorgestrel 100 mcg and Ethinyl Estradiol 20 mcg
* Drug: Levonorgestrel 150 mcg and Ethinyl Estradiol 30 mcg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy women,aged 20-35 years who wish to use a contraceptive. Women without reproductive system infection complications. Willingness to not use other forms of hormonal treatment. Three regular menstrual cycles before the study(21-35 days per cycle with 3-7 day's bleeding period, without amenorrhea or irregular bleeding). Signed informed consent prior to entry into the trial. Exclusion Criteria: Any contraindication to the use of oral contraceptives. Vascular, metabolic, hepatic, renal, oncologic and other diseases.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LNG100 mcg/EE20 mcg<br> | Drug: Levonorgestrel 100 mcg and Ethinyl Estradiol 20 mcg<br>* Tablet, orally, opd<br>|
| Active Comparator: LNG 150mcg/ EE 30mcg<br> | Drug: Levonorgestrel 150 mcg and Ethinyl Estradiol 30 mcg<br>* Tablet, orally, opd<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary efficacy variable is the number of unintended pregnancies as measured by the Pearl Index (PI) during 13 cycles of treatment |  | From fist dose to 13 treatment cycles (1 cycle=28 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Menstrual Cycle Control | Menstrual cycle control was evaluated by analyzing cycle characteristics, such as cycle length, the incidences of breakthrough bleeding, spotting, and amenorrhea and the duration and intensity of withdrawal bleeding. During the trial, spotting was defined as a light flow that did not necessitate sanitary protection, whereas bleeding was defined as a heavier flow that was similar to normal menstrual flow and necessitated sanitary protection. | From fist dose to 13 treatment cycles (1 cycle=28 days) | 
| Weight changes |  | From fist dose to 13 treatment cycles (1 cycle=28 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Levonorgestrel；, Ethinyl Estradiol；, Oral Contraceptive