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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01397097




Registration number
NCT01397097
Ethics application status
Date submitted
18/07/2011
Date registered
19/07/2011
Date last updated
25/07/2016

Titles & IDs
Public title
LCS12 vs. ENG Subdermal Implant (Nexplanon) Discontinuation Rate Study
Scientific title
Multicenter, Open-label, Randomized, Controlled Parallel-group Study to Assess Discontinuation Rates, Bleeding Patterns, User Satisfaction and Adverse Event Profile of LCS12 in Comparison to Etonorgestrel Subdermal Implant Over 12 Months of Use in Women 18 to 35 Years of Age
Secondary ID [1] 0 0
2010-023911-32
Secondary ID [2] 0 0
13363
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 - LNG-IUS (BAY 86-5028)
Treatment: Drugs - 68 mg etonorgestrel implant for subdermal use (Nexplanon)

Experimental: Arm 1 -

Active comparator: Arm 2 -


Treatment: Drugs: LNG-IUS (BAY 86-5028)
LCS12 insertion will occur at randomization visit (Visit 2). Duration of study treatment is 12 months with an follow-up extension for up to 3 years

Treatment: Drugs: 68 mg etonorgestrel implant for subdermal use (Nexplanon)
Implant insertion will occur at randomization visit (Visit 2). Duration of study treatment is 12 months, may be continued up to 3 years under standard care.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Discontinuation rate by treatment group
Timepoint [1] 0 0
at 12 months
Secondary outcome [1] 0 0
Discontinuation rates by treatment group
Timepoint [1] 0 0
at 6 months and by reason at 6 and 12 months
Secondary outcome [2] 0 0
Overall satisfaction rating and questionnaires on User satisfaction and bleeding and Contraceptive tolerability
Timepoint [2] 0 0
at 6 and 12 months
Secondary outcome [3] 0 0
Pregnancy rate, as determined by Pearl index
Timepoint [3] 0 0
at 12 months

Eligibility
Key inclusion criteria
* Signed and dated the informed consent
* Healthy female subjects in need of contraception
* Age: between 18 and 35 years (inclusive) at Screening visit
* Normal or clinically insignificant cervical smear not requiring further follow up (a cervical smear has to be taken at screening visit or a normal result has to be documented within the previous six months). HPV testing in subjects with ASCUS can be used as an adjunctive test. Subjects with ASCUS can be included if they are negative for high-risk HPV strains.
* History of regular cyclic menstrual periods as determined by subject's history, subject has regular menstrual cycles (length of cycle 21 - 35 days). (Subject's history while not using hormonal contraceptives is sufficient, no washout period is required).
* Subject is willing and able to attend the scheduled study visits and to comply with the study procedures.
Minimum age
18 Years
Maximum age
35 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Pregnancy or currently lactating
* Vaginal delivery, cesarean delivery or abortion within 6 weeks prior to Screening visit. Note: Postpartum LCS12 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.
* Infected abortion or postpartum endometritis within 3 months prior to the Screening visit.
* Undiagnosed abnormal genital bleeding.
* Acute lower genital tract infection (until successfully treated)
* Acute or history of recurrent, pelvic inflammatory disease.
* Congenital or acquired uterine anomaly or any distortion of the uterine cavity (e.g. by fibroids) that, in the opinion of the investigator or designee, would cause problems during insertion, retention, or removal of LCS12. (Note: a pre-insertion ultrasound is not necessary. However, if based on subject history or physical exam findings, there is a suspicion of uterine anomaly or any distortion of the uterine cavity, appropriate diagnostic measures should be taken prior to randomization)
* History of, diagnosed or suspected genital malignancy, and untreated cervical dysplasia.
* Clinically significant endometrial polyp(s) that, in the opinion of the investigator or designee, may interfere with the assessment of the bleeding profile during the study. (Note: a pre-insertion ultrasound is not necessary. However, if based on subject history or physical exam findings, there is a suspicion of polyps, appropriate diagnostic measures should be taken prior to randomization.)
* Has previously failed screening for this study
* Any disease or condition that may worsen under hormonal treatment according to the assessment and opinion of the investigator. The following are examples of such conditions or diseases:

* Cardiovascular
* Presence or a history of venous or arterial thrombotic/thromboembolic events (e.g., deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident, including prodromi (e.g. transient ischemic attack, angina pectoris)
* Repeated measurements of systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg.

Liver

* Presence or history of liver tumors (benign or malignant)
* Presence or history of severe hepatic disease as long as liver function values have not returned to normal
* Jaundice and/or pruritus related to cholestasis (Gilbert's syndrome excepted)
* History of cholestatic jaundice associated with pregnancy or previous COC use

- Other diseases:
* Malignant or premalignant disease (excluding melanoma)
* History of migraine with focal neurologic symptoms

* Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
* Clinically significant ovarian cyst (defined as abnormal non-functional cysts) (Note: a pre-insertion ultrasound is not necessary. However, if based on subject history or physical exam findings, there is a suspicion of a clinically significant cyst, appropriate diagnostic measures should be taken prior to randomization.)
* Any diseases or conditions that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism or altered excretion of the study medication
* Other contraceptive methods:
* Sterilization
* Use of any long-acting injectable sex-hormone preparations within 10 months prior to the Randomization visit. The use of non study oral, vaginal, or transdermal hormonal contraception, intrauterine devices (IUDs) with or without hormonal release, and implants is prohibited during treatment.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled 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
Parallel
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
1/09/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2015
Sample size
Target
Accrual to date
Final
766
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
- Ashfield
Recruitment hospital [2] 0 0
- Sydney
Recruitment hospital [3] 0 0
- North Adelaide
Recruitment hospital [4] 0 0
- Parkville
Recruitment hospital [5] 0 0
- Nedlands
Recruitment postcode(s) [1] 0 0
2031 - Ashfield
Recruitment postcode(s) [2] 0 0
2031 - Sydney
Recruitment postcode(s) [3] 0 0
5006 - North Adelaide
Recruitment postcode(s) [4] 0 0
3053 - Parkville
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
Finland
State/province [1] 0 0
Espoo
Country [2] 0 0
Finland
State/province [2] 0 0
Helsinki
Country [3] 0 0
Finland
State/province [3] 0 0
Kuopio
Country [4] 0 0
Finland
State/province [4] 0 0
Tampereen yliopisto
Country [5] 0 0
Finland
State/province [5] 0 0
Tampere
Country [6] 0 0
Finland
State/province [6] 0 0
Turku
Country [7] 0 0
France
State/province [7] 0 0
Biarritz
Country [8] 0 0
France
State/province [8] 0 0
Bordeaux
Country [9] 0 0
France
State/province [9] 0 0
Marseille
Country [10] 0 0
France
State/province [10] 0 0
Quetigny
Country [11] 0 0
France
State/province [11] 0 0
Reims
Country [12] 0 0
France
State/province [12] 0 0
Schiltigheim
Country [13] 0 0
France
State/province [13] 0 0
Seclin
Country [14] 0 0
France
State/province [14] 0 0
Strasbourg
Country [15] 0 0
Norway
State/province [15] 0 0
Elverum
Country [16] 0 0
Norway
State/province [16] 0 0
Haugesund
Country [17] 0 0
Norway
State/province [17] 0 0
Ski
Country [18] 0 0
Norway
State/province [18] 0 0
Straume
Country [19] 0 0
Norway
State/province [19] 0 0
Trondheim
Country [20] 0 0
Sweden
State/province [20] 0 0
Göteborg
Country [21] 0 0
Sweden
State/province [21] 0 0
Linköping
Country [22] 0 0
Sweden
State/province [22] 0 0
Luleå
Country [23] 0 0
Sweden
State/province [23] 0 0
Malmö
Country [24] 0 0
Sweden
State/province [24] 0 0
Stockholm
Country [25] 0 0
Sweden
State/province [25] 0 0
Uppsala
Country [26] 0 0
Sweden
State/province [26] 0 0
Örebro
Country [27] 0 0
United Kingdom
State/province [27] 0 0
Cambridgeshire
Country [28] 0 0
United Kingdom
State/province [28] 0 0
South Yorkshire
Country [29] 0 0
United Kingdom
State/province [29] 0 0
West Yorkshire
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Liverpool
Country [31] 0 0
United Kingdom
State/province [31] 0 0
London

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

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective is to demonstrate that discontinuation rates in women (ages 18-35 years inclusive) using LCS12 are not higher than those seen in women using ENG subdermal implant over a period of 12 months.

Secondary objectives are to observe the bleeding patterns, adverse event profiles and the occurrence of unintended pregnancies. Additionally, data on user satisfaction, IUS expulsions and implant site complications will be collected.
Trial website
https://clinicaltrials.gov/study/NCT01397097
Trial related presentations / publications
Apter D, Briggs P, Tuppurainen M, Grunert J, Lukkari-Lax E, Rybowski S, Gemzell-Danielsson K. A 12-month multicenter, randomized study comparing the levonorgestrel intrauterine system with the etonogestrel subdermal implant. Fertil Steril. 2016 Jul;106(1):151-157.e5. doi: 10.1016/j.fertnstert.2016.02.036. Epub 2016 Mar 24.
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/NCT01397097