Study Evaluating Levonorgestrel and Ethinyl Estradiol for Oral Contraception

Phase 3UnknownNCT02021097

Regenex Pharmaceutical, China1,008 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,008

Conditions

Oral Contraceptive

Interventions

Levonorgestrel 100 mcg and Ethinyl Estradiol 20 mcgDRUG

Tablet, orally, opd

Levonorgestrel 150 mcg and Ethinyl Estradiol 30 mcgDRUG

Tablet, orally, opd

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (21)

Unnamed facility

Beijing, Beijing Municipality, China

NOT_YET_RECRUITING

Unnamed facility

Beijing, Beijing Municipality, China

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

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.

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

Weight changes

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

Central Contacts

Chengliang Xiong, Dr

CONTACT

clxiong951@sina.cn

Data from ClinicalTrials.gov

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