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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00884260




Registration number
NCT00884260
Ethics application status
Date submitted
16/04/2009
Date registered
20/04/2009
Date last updated
21/08/2014

Titles & IDs
Public title
GA Levonorgestrel Intrauterine Contraceptive System (LCS) Phase III Study China
Scientific title
Multi-center, Open Label, Single Arm Study to Assess Efficacy, Safety, Bleeding Pattern and Pharmacokinetics of the Ultra Low Dose Levonorgestrel Intrauterine Contraceptive System (LCS) for a Maximum of 3 Years in Women 18 to 40 Years of Age
Secondary ID [1] 0 0
MAGIC
Secondary ID [2] 0 0
91775
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Contraception 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Levonorgestrel IUS (LCS, BAY86-5028)

Experimental: Arm 1 -


Treatment: Drugs: Levonorgestrel IUS (LCS, BAY86-5028)
In Vitro release rate: 12µg LNG/24h
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary efficacy variable is the occurrence of pregnancy, the Pearl Index (PI) is defined as the number of pregnancies per 100 woman years.
Timepoint [1] 0 0
3 years
Secondary outcome [1] 0 0
LCS expulsion rate
Timepoint [1] 0 0
3 years
Secondary outcome [2] 0 0
Discontinuation rates
Timepoint [2] 0 0
3 years
Secondary outcome [3] 0 0
Adverse events
Timepoint [3] 0 0
3 years
Secondary outcome [4] 0 0
Laboratory tests
Timepoint [4] 0 0
3 years

Eligibility
Key inclusion criteria
* Has, in the opinion of the investigator, suitable general and uterine conditions for inserting the LCS.
* 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).
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Known or suspected pregnancy or is lactating.
* 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2013
Sample size
Target
Accrual to date
Final
918
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
- Ashfield
Recruitment hospital [2] 0 0
- Herston
Recruitment hospital [3] 0 0
- Parkville
Recruitment hospital [4] 0 0
- Subiaco
Recruitment postcode(s) [1] 0 0
2031 - Ashfield
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
3052 - Parkville
Recruitment postcode(s) [4] 0 0
6008 - Subiaco
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Guangdong
Country [2] 0 0
China
State/province [2] 0 0
Hubei
Country [3] 0 0
China
State/province [3] 0 0
Jiangsu
Country [4] 0 0
China
State/province [4] 0 0
Liaoning
Country [5] 0 0
China
State/province [5] 0 0
Shandong
Country [6] 0 0
China
State/province [6] 0 0
Sichuan
Country [7] 0 0
China
State/province [7] 0 0
Beijing
Country [8] 0 0
China
State/province [8] 0 0
Chongqing
Country [9] 0 0
China
State/province [9] 0 0
Shanghai
Country [10] 0 0
Korea, Republic of
State/province [10] 0 0
Gyeonggido
Country [11] 0 0
Korea, Republic of
State/province [11] 0 0
Korea
Country [12] 0 0
Korea, Republic of
State/province [12] 0 0
Seoul

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bayer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to assess the efficacy, safety, bleeding pattern of low dose LNG (12 mg/ 24 hrs), delivered locally by a new intrauterine contraceptive system suitable for use by women 18 to 40 years of age. In addition, pharmacokinetic assessments will be performed.
Trial website
https://clinicaltrials.gov/study/NCT00884260
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00884260