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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02021097

Enrollment

1008

Registered

2013-12-27

Start date

2012-02-29

Completion date

2016-02-29

Last updated

2013-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Contraceptive

Keywords

Levonorgestrel；, Ethinyl Estradiol；, Oral Contraceptive

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.

Interventions

DRUGLevonorgestrel 100 mcg and Ethinyl Estradiol 20 mcg

Tablet, orally, opd

DRUGLevonorgestrel 150 mcg and Ethinyl Estradiol 30 mcg

Tablet, orally, opd

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 35 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	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

Measure	Time frame	Description
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.
Weight changes	From fist dose to 13 treatment cycles (1 cycle=28 days)	—

Countries

China

Contacts

Primary ContactChengliang Xiong, Dr

clxiong951@sina.cn

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026