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Study Evaluating Levonorgestrel and Ethinyl Estradiol for Oral Contraception

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02021097
Recruitment Status : Unknown
Verified December 2013 by Regenex Pharmaceutical, China.
Recruitment status was:  Recruiting
First Posted : December 27, 2013
Last Update Posted : December 27, 2013
Information provided by (Responsible Party):
Regenex Pharmaceutical, China

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.

Condition or disease Intervention/treatment Phase
Oral Contraceptive Drug: Levonorgestrel 100 mcg and Ethinyl Estradiol 20 mcg Drug: Levonorgestrel 150 mcg and Ethinyl Estradiol 30 mcg Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1008 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2012
Estimated Primary Completion Date : February 2015
Estimated Study Completion Date : February 2016

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

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. Weight changes [ Time Frame: From fist dose to 13 treatment cycles (1 cycle=28 days) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02021097

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Contact: Chengliang Xiong, Dr clxiong951@sina.cn

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China, Beijing
Not yet recruiting
Beijing, Beijing, China, 100039
Not yet recruiting
Beijing, Beijing, China, 100730
China, Chongqing
Chongqing, Chongqing, China, 400010
Chongqing, Chongqing, China, 400042
China, Guangdong
Guangzhou, Guangdong, China, 510120
Shantou, Guangdong, China, 515041
Zhongshan, Guangdong, China, 528403
China, Guizhou
Guiyang, Guizhou, China, 550000
Guiyang, Guizhou, China, 550002
China, Hubei
Wuhan, Hubei, China, 430030
China, Hunan
Changde, Hunan, China, 415003
Changsha, Hunan, China, 410013
China, Jiangsu
Nanjing, Jiangsu, China, 210009
Nanjing, Jiangsu, China, 210036
Yangzhou, Jiangsu, China, 225009
China, Shanghai
Shanghai, Shanghai, China, 200021
China, Shanxi
Taiyuan, Shanxi, China, 030013
Xi'an, Shanxi, China, 710061
China, Tianjin
Tianjin, Tianjin, China, 300211
China, Xinjiang
Wulumuqi, Xinjiang, China, 830054
China, Zhejiang
Not yet recruiting
Taizhou, Zhejiang, China, 317000
Sponsors and Collaborators
Regenex Pharmaceutical, China
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Principal Investigator: Chengliang Xiong, Dr Family Planning Research Institute of TJMC,HUST
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Responsible Party: Regenex Pharmaceutical, China
ClinicalTrials.gov Identifier: NCT02021097    
Other Study ID Numbers: RH-ZQ-03RCT
First Posted: December 27, 2013    Key Record Dates
Last Update Posted: December 27, 2013
Last Verified: December 2013
Keywords provided by Regenex Pharmaceutical, China:
Ethinyl Estradiol;
Oral Contraceptive
Additional relevant MeSH terms:
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Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Ethinyl Estradiol
Polyestradiol phosphate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents, Hormonal
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptives, Oral, Hormonal