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

Regenex Pharmaceutical, China0 sites1,008 target enrollmentFebruary 2012

ConditionsOral Contraceptive

InterventionsLevonorgestrel 100 mcg and Ethinyl Estradiol 20 mcg Levonorgestrel 150 mcg and Ethinyl Estradiol 30 mcg

DrugsLevonorgestrel 100 mcg and Ethinyl Estradiol 20 mcg Levonorgestrel 150 mcg and Ethinyl Estradiol 30 mcg

Overview

Phase: Phase 3
Intervention: Levonorgestrel 100 mcg and Ethinyl Estradiol 20 mcg
Conditions: Oral Contraceptive
Sponsor: Regenex Pharmaceutical, China
Enrollment: 1008
Primary Endpoint: The primary efficacy variable is the number of unintended pregnancies as measured by the Pearl Index (PI) during 13 cycles of treatment
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2012

End Date

February 2016

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Regenex Pharmaceutical, China

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

LNG100 mcg/EE20 mcg

Intervention: Levonorgestrel 100 mcg and Ethinyl Estradiol 20 mcg

LNG 150mcg/ EE 30mcg

Intervention: Levonorgestrel 150 mcg and Ethinyl Estradiol 30 mcg

Outcomes

Primary Outcomes

The primary efficacy variable is the number of unintended pregnancies as measured by the Pearl Index (PI) during 13 cycles of treatment

Time Frame: From fist dose to 13 treatment cycles (1 cycle=28 days)

Secondary Outcomes

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))