Study Evaluating Levonorgestrel and Ethinyl Estradiol for Oral Contraception

Phase 3

• Conditions: Oral Contraceptive
• Interventions: Drug: Levonorgestrel 150 mcg and Ethinyl Estradiol 30 mcg; Drug: Levonorgestrel 100 mcg and Ethinyl Estradiol 20 mcg

• Registration Number: NCT02021097
• Lead Sponsor: Regenex Pharmaceutical, China

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2013-03-12
• Status Verified: 2013-12
• Study First Submitted QC: 2013-12-19
• Last Update Submitted: 2013-12-19
• Study First Posted: 2013-12-27
• Last Update Posted: 2013-12-27
• Primary Completion: 2015-02
• Study Completion: 2016-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1008

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LNG 150mcg/ EE 30mcg	Levonorgestrel 150 mcg and Ethinyl Estradiol 30 mcg	-
LNG100 mcg/EE20 mcg	Levonorgestrel 100 mcg and Ethinyl Estradiol 20 mcg	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Weight changes	From fist dose to 13 treatment cycles (1 cycle=28 days)
Menstrual Cycle Control	From fist dose to 13 treatment cycles (1 cycle=28 days)	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.