Study Evaluating Levonorgestrel and Ethinyl Estradiol for Oral Contraception
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
1 other identifier
interventional
1,008
1 country
21
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2012
Typical duration for phase_3
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 12, 2013
CompletedFirst Posted
Study publicly available on registry
December 27, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedDecember 27, 2013
December 1, 2013
3 years
March 12, 2013
December 19, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary efficacy variable is the number of unintended pregnancies as measured by the Pearl Index (PI) during 13 cycles of treatment
From fist dose to 13 treatment cycles (1 cycle=28 days)
Secondary Outcomes (2)
Menstrual Cycle Control
From fist dose to 13 treatment cycles (1 cycle=28 days)
Weight changes
From fist dose to 13 treatment cycles (1 cycle=28 days)
Study Arms (2)
LNG100 mcg/EE20 mcg
EXPERIMENTALLNG 150mcg/ EE 30mcg
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Any contraindication to the use of oral contraceptives.
- Vascular, metabolic, hepatic, renal, oncologic and other diseases.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Unknown Facility
Beijing, Beijing Municipality, 100039, China
Unknown Facility
Beijing, Beijing Municipality, 100730, China
Unknown Facility
Chongqing, Chongqing Municipality, 400010, China
Unknown Facility
Chongqing, Chongqing Municipality, 400042, China
Unknown Facility
Guangzhou, Guangdong, 510120, China
Unknown Facility
Shantou, Guangdong, 515041, China
Unknown Facility
Zhongshan, Guangdong, 528403, China
Unknown Facility
Guiyang, Guizhou, 550000, China
Unknown Facility
Guiyang, Guizhou, 550002, China
Unknown Facility
Wuhan, Hubei, 430030, China
Unknown Facility
Changde, Hunan, 415003, China
Unknown Facility
Changsha, Hunan, 410013, China
Unknown Facility
Nanjing, Jiangsu, 210009, China
Unknown Facility
Nanjing, Jiangsu, 210036, China
Unknown Facility
Yangzhou, Jiangsu, 225009, China
Unknown Facility
Shanghai, Shanghai Municipality, 200021, China
Unknown Facility
Taiyuan, Shanxi, 030013, China
Unknown Facility
Xi’an, Shanxi, 710061, China
Unknown Facility
Tianjin, Tianjin Municipality, 300211, China
Unknown Facility
Ürümqi, Xinjiang, 830054, China
Unknown Facility
Taizhou, Zhejiang, 317000, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chengliang Xiong, Dr
Family Planning Research Institute of TJMC,HUST
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2013
First Posted
December 27, 2013
Study Start
February 1, 2012
Primary Completion
February 1, 2015
Study Completion
February 1, 2016
Last Updated
December 27, 2013
Record last verified: 2013-12