GA Levonorgestrel Intrauterine Contraceptive System (LCS) Phase III Study China
NCT ID: NCT00884260
Last Updated: 2014-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
918 participants
INTERVENTIONAL
2009-04-30
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm 1
Levonorgestrel IUS (LCS, BAY86-5028)
In Vitro release rate: 12µg LNG/24h
Interventions
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Levonorgestrel IUS (LCS, BAY86-5028)
In Vitro release rate: 12µg LNG/24h
Eligibility Criteria
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Inclusion Criteria
* Normal cervical smear (normal cervical smear within the last six months prior to visit 1 presented in writing can be accepted. The cervical smear should be analyzed and reported according to the Bethesda System.)
* Has clinically normal safety laboratory results (i.e., inside the specified range for inclusion).
* Has regular menstrual cycles (length of cycle 21-35 days) (i.e., endogenous cyclicity without hormonal contraceptive use).
Exclusion Criteria
* Vaginal delivery, cesarean delivery, or abortion within 6 weeks prior to visit 2.
Note: Postpartum insertions should be postponed until uterus is fully involuted, however not earlier than 6 weeks after delivery. If involution is substantially delayed, consider waiting until 12 weeks postpartum. In case of a difficult insertion and/or exceptional pain or bleeding during or after insertion, physical examination and ultrasound should be performed immediately to exclude perforation.
* History of ectopic pregnancies. Note: For Korea only: History of ectopic pregnancies or high probability of ectopic gestation.
* Infected abortion within 3 months prior to visit 1. Note: For Korea only: Endometritis after delivery or infected abortion within 3 months prior to visit 1.
* Abnormal uterine bleeding of unknown origin.
* Any genital infection (until successfully treated).
* History of, or current, pelvic inflammatory disease
* Congenital or acquired uterine anomaly.
* Any distortion of the uterine cavity (by e.g., fibroids) likely to cause problems (in the opinion of the investigator) during insertion, retention or removal of the LCS.
* History of, diagnosed or suspected genital malignancy, and untreated cervical dysplasia.
* Current deep venous thrombosis or thrombophlebitis; history of deep venous thrombosis.
* Clinically significant endometrial polyp(s), which, in the opinion of the investigator, will interfere with the assessment of the bleeding profile during the study
* Clinically significant ovarian cyst(s)
* Use of any long-acting injectable sex-hormone preparations within 12 months prior to start of study medication, and if entering subset: any sex-hormone administration within one month prior to start of the study medication.
18 Years
40 Years
FEMALE
Yes
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Ashfield, New South Wales, Australia
Herston, Queensland, Australia
Parkville, Victoria, Australia
Subiaco, Western Australia, Australia
Guangzhou, Guangdong, China
Wuhan, Hubei, China
Nanjing, Jiangsu, China
Nanjing, Jiangsu, China
Nanjing, Jiangsu, China
Dalian, Liaoning, China
Jinan, Shandong, China
Chengdu, Sichuan, China
Beijing, , China
Beijing, , China
Beijing, , China
Chongqing, , China
Chongqing, , China
Shanghai, , China
Shanghai, , China
Shanghai, , China
Sungnam-si, Gyeonggido, South Korea
Seoul, Korea, South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Countries
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Other Identifiers
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MAGIC
Identifier Type: OTHER
Identifier Source: secondary_id
311966
Identifier Type: OTHER
Identifier Source: secondary_id
91775
Identifier Type: -
Identifier Source: org_study_id
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