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Study Evaluating Levonorgestrel and Ethinyl Estradiol for Oral Contraception

R

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)

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

Trial contacts and locations

21

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Central trial contact

Chengliang Xiong, Dr

Data sourced from clinicaltrials.gov

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