Study Evaluating Levonorgestrel and Ethinyl Estradiol for Oral Contraception

Regenex Pharmaceutical

Status and phase: Unknown; Phase 3

Conditions: Oral Contraceptive

Treatments: Drug: Levonorgestrel 100 mcg and Ethinyl Estradiol 20 mcg; Drug: Levonorgestrel 150 mcg and Ethinyl Estradiol 30 mcg

Study type: Interventional

Funder types: Other

Identifiers

NCT02021097

RH-ZQ-03RCT

Details and patient eligibility

About

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.

Enrollment: 1,008 estimated patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,008 participants in 2 patient groups

LNG100 mcg/EE20 mcg

Experimental group

Treatment:

Drug: Levonorgestrel 100 mcg and Ethinyl Estradiol 20 mcg

LNG 150mcg/ EE 30mcg

Active Comparator group

Treatment:

Drug: Levonorgestrel 150 mcg and Ethinyl Estradiol 30 mcg