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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
Sponsor:
Information provided by (Responsible Party):
Regenex Pharmaceutical, China

Study Description
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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

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arms and Interventions
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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


Outcome Measures
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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) ]

Eligibility Criteria
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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
Criteria

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.
Contacts and Locations
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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


Contacts
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Contact: Chengliang Xiong, Dr clxiong951@sina.cn

Locations
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China, Beijing
Not yet recruiting
Beijing, Beijing, China, 100039
Not yet recruiting
Beijing, Beijing, China, 100730
China, Chongqing
Recruiting
Chongqing, Chongqing, China, 400010
Recruiting
Chongqing, Chongqing, China, 400042
China, Guangdong
Recruiting
Guangzhou, Guangdong, China, 510120
Recruiting
Shantou, Guangdong, China, 515041
Recruiting
Zhongshan, Guangdong, China, 528403
China, Guizhou
Recruiting
Guiyang, Guizhou, China, 550000
Recruiting
Guiyang, Guizhou, China, 550002
China, Hubei
Recruiting
Wuhan, Hubei, China, 430030
China, Hunan
Recruiting
Changde, Hunan, China, 415003
Recruiting
Changsha, Hunan, China, 410013
China, Jiangsu
Recruiting
Nanjing, Jiangsu, China, 210009
Recruiting
Nanjing, Jiangsu, China, 210036
Recruiting
Yangzhou, Jiangsu, China, 225009
China, Shanghai
Recruiting
Shanghai, Shanghai, China, 200021
China, Shanxi
Recruiting
Taiyuan, Shanxi, China, 030013
Recruiting
Xi'an, Shanxi, China, 710061
China, Tianjin
Recruiting
Tianjin, Tianjin, China, 300211
China, Xinjiang
Recruiting
Wulumuqi, Xinjiang, China, 830054
China, Zhejiang
Not yet recruiting
Taizhou, Zhejiang, China, 317000
Sponsors and Collaborators
Regenex Pharmaceutical, China
Investigators
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Principal Investigator: Chengliang Xiong, Dr Family Planning Research Institute of TJMC,HUST
More Information
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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:
Levonorgestrel；
Ethinyl Estradiol；
Oral Contraceptive
Additional relevant MeSH terms:
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Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Levonorgestrel
Ethinyl Estradiol
Estradiol
Polyestradiol phosphate
Estrogens
Hormones
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