Trial | NCT02021097  Report issue

Title

Study Evaluating Levonorgestrel and Ethinyl Estradiol for Oral Contraception
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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    norgestrel ethinyl estradiol ...

  • Study Participants

    1008
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.
Study Started
Feb 29
2012
Primary Completion
Feb 28
2015
Anticipated
Study Completion
Feb 29
2016
Anticipated
Last Update
Dec 27
2013
Estimate

Drug Levonorgestrel 100 mcg and Ethinyl Estradiol 20 mcg

Tablet, orally, opd

Drug Levonorgestrel 150 mcg and Ethinyl Estradiol 30 mcg

Tablet, orally, opd

LNG100 mcg/EE20 mcg Experimental

LNG 150mcg/ EE 30mcg Active Comparator

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.
No Results Posted