Study Evaluating Levonorgestrel and Ethinyl Estradiol for Oral Contraception

December 19, 2013 updated by: Regenex Pharmaceutical, China

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1008

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100039
        • Not yet recruiting
      • Beijing, Beijing, China, 100730
        • Not yet recruiting
    • Chongqing
      • Chongqing, Chongqing, China, 400010
        • Recruiting
      • Chongqing, Chongqing, China, 400042
        • Recruiting
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Recruiting
      • Shantou, Guangdong, China, 515041
        • Recruiting
      • Zhongshan, Guangdong, China, 528403
        • Recruiting
    • Guizhou
      • Guiyang, Guizhou, China, 550000
        • Recruiting
      • Guiyang, Guizhou, China, 550002
        • Recruiting
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Recruiting
    • Hunan
      • Changde, Hunan, China, 415003
        • Recruiting
      • Changsha, Hunan, China, 410013
        • Recruiting
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Recruiting
      • Nanjing, Jiangsu, China, 210036
        • Recruiting
      • Yangzhou, Jiangsu, China, 225009
        • Recruiting
    • Shanghai
      • Shanghai, Shanghai, China, 200021
        • Recruiting
    • Shanxi
      • Taiyuan, Shanxi, China, 030013
        • Recruiting
      • Xi'an, Shanxi, China, 710061
        • Recruiting
    • Tianjin
      • Tianjin, Tianjin, China, 300211
        • Recruiting
    • Xinjiang
      • Wulumuqi, Xinjiang, China, 830054
        • Recruiting
    • Zhejiang
      • Taizhou, Zhejiang, China, 317000
        • Not yet recruiting

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LNG100 mcg/EE20 mcg
Drug: Levonorgestrel 100 mcg and Ethinyl Estradiol 20 mcg
Tablet, orally, opd
Active Comparator: LNG 150mcg/ EE 30mcg
Drug: Levonorgestrel 150 mcg and Ethinyl Estradiol 30 mcg
Tablet, orally, opd

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Menstrual Cycle Control
Time Frame: 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.
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)
From fist dose to 13 treatment cycles (1 cycle=28 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regenex Pharmaceutical, China

Investigators

  • Principal Investigator: Chengliang Xiong, Dr, Family Planning Research Institute of TJMC,HUST

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Anticipated)

February 1, 2015

Study Completion (Anticipated)

February 1, 2016

Study Registration Dates

First Submitted

March 12, 2013

First Submitted That Met QC Criteria

December 19, 2013

First Posted (Estimate)

December 27, 2013

Study Record Updates

Last Update Posted (Estimate)

December 27, 2013

Last Update Submitted That Met QC Criteria

December 19, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RH-ZQ-03RCT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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