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LNG-IUS

Phase 3

Contraception | Small molecule | Endocrine |Bayer AG|Last Updated: Jul 25, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment766

FDA Designations

No designations recorded

Clinical trial landscape

LNG-IUS · 1 trial · 1 indication

Phase 3 1
NCT01397097LCS12 vs. ENG Subdermal Implant (Nexplanon) Discontinuation Rate StudyContraception
COMPLETED766 Analytics
PHASE3COMPLETED
LCS12 vs. ENG Subdermal Implant (Nexplanon) Discontinuation Rate Study
Contraception
NCT01397097766
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Study Endpoints

Primary Endpoints

Discontinuation rate by treatment group
at 12 months

Secondary Endpoints

Discontinuation rates by treatment group
at 6 months and by reason at 6 and 12 months
Overall satisfaction rating and questionnaires on User satisfaction and bleeding and Contraceptive tolerability
at 6 and 12 months
Pregnancy rate, as determined by Pearl index
at 12 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -
Arm 2ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
LNG-IUS (BAY 86-5028)DRUGLCS12 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
68 mg etonorgestrel implant for subdermal use (Nexplanon)DRUGImplant 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.
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Eligibility Criteria

Age Range18 Years to 35 Years
SexFEMALE
Healthy VolunteersNo
Study Sites43

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 scree...

Countries:AustraliaFinlandFranceNorwaySwedenUnited Kingdom
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Frequently asked questions about LNG-IUS

What is LNG IUS used for?

LNG IUS, also known as the levonorgestrel intrauterine system, is used for contraception and as part of hormone replacement therapy (HRT) in menopause. It is being developed by Bayer AG for these indications and is currently in Phase 3 clinical development.

What does LNG IUS target?

LNG IUS is a small molecule that delivers the hormone levonorgestrel locally in the uterus. It is used for contraception and as part of hormone replacement therapy in menopause, though its specific molecular target is not detailed.

Who makes LNG IUS?

LNG IUS is developed by Bayer AG, a pharmaceutical company traded under the ticker BAYRY. The drug is currently in Phase 3 clinical development for use in contraception and as part of hormone replacement therapy for menopause.

What phase is LNG IUS in?

LNG IUS is in Phase 3 clinical development. It is an investigational drug and is not yet approved for use. Clinical trials have been completed to assess its use in contraception and as part of hormone replacement therapy in menopause.

What clinical trials is LNG IUS in?

LNG IUS has been studied in two completed Phase 3 clinical trials. One trial, NCT00185458, assessed the transfer from using LNG IUS as a contraceptive to using it as part of hormone replacement therapy in menopause, enrolling 394 women. Another trial, NCT01397097, compared discontinuation rates of LNG IUS versus the ENG subdermal implant, enrolling 766 women.

Is LNG IUS the same as levonorgestrel intrauterine system?

Yes, LNG IUS is the same as the levonorgestrel intrauterine system. It is a small molecule drug developed by Bayer AG for contraception and as part of hormone replacement therapy in menopause, and it is currently in Phase 3 clinical development.