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BAY98-7443

Phase 2

Contraception | Small molecule | Endocrine |Bayer AG|Last Updated: Aug 12, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment177

FDA Designations

No designations recorded

Clinical trial landscape

BAY98-7443 · 1 trial · 1 indication

Phase 2 1
NCT03562624A Study to Compare 3 Doses of a Hormonal Intra-uterine Device Containing Levonorgestrel and Indomethacin With a Hormonal Intra-uterine Device Containing Only Levonorgestrel to Assess the Effect and Safety of the Combined ComponentsContraception
COMPLETED177 Analytics
PHASE2COMPLETED
A Study to Compare 3 Doses of a Hormonal Intra-uterine Device Containing Levonorgestrel and Indomethacin With a Hormonal Intra-uterine Device Containing Only Levonorgestrel to Assess the Effect and Safety of the Combined Components
Contraception
NCT03562624177
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Study Endpoints

Primary Endpoints

Number of uterine bleeding/spotting (B/S) days during treatment
90 days after start of treatment

Recorded by participants with electronic diary

Secondary Endpoints

Number of subjects showing endometrial histology typical for intrauterine LNG application in biopsies taken at the end of treatment
On day 90 after start of treatment
Frequency of treatment emergent adverse events
90 days after start of treatment
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BAY98-7443 (low IND dose)EXPERIMENTALCombi IUS Treatment, LNG (Levonorgestrel) with lowest dose of IND (indomethacin)
BAY98-7443 (middle IND dose)EXPERIMENTALCombi IUS Treatment, LNG with medium dose of IND
BAY98-7443 (high IND dose)EXPERIMENTALCombi IUS Treatment, LNG with highest dose of IND
Marketed comparatorACTIVE_COMPARATORMarketed comparator IUS

Interventions

NameTypeDescription
BAY98-7443DRUGActive ingredient content (in mg IND/LNG): low dose 6.5 / 13.5; middle dose 12.5 / 13.5; high dose 15.4 / 13.5
Levonogestrel (Skyla, BAY86-5028)DRUGComparative LNG dose
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Eligibility Criteria

Age Range18 Years to 45 Years
SexFEMALE
Healthy VolunteersYes
Study Sites7

Inclusion Criteria: * Agreement to use an acceptable non-hormonal method of contraception (i.e. male or female condom with or without spermicide; cap, diaphragm or sponge with spermicide) when sexually active. This applies during the pre-treatment cycle and directly following the treatment period u...

Countries:GermanyUnited Kingdom
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Frequently asked questions about BAY98-7443

What is BAY98-7443 used for?

BAY98-7443 is an investigational small molecule being developed for contraception. It is being studied as a hormonal intra-uterine device containing levonorgestrel and indomethacin, intended to assess the effect and safety of the combined components for preventing pregnancy.

Who makes BAY98-7443?

BAY98-7443 is being developed by Bayer AG, a German pharmaceutical company traded on the OTC market under the ticker BAYRY. The company is conducting clinical research on this investigational contraceptive product.

What phase is BAY98-7443 in?

BAY98-7443 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 2 trial has been completed, and the product remains under clinical investigation for contraception.

What clinical trials is BAY98-7443 in?

BAY98-7443 has one completed Phase 2 clinical trial, registered as NCT03562624. This randomized, double-blind, active-controlled study enrolled 177 female participants in Germany and the United Kingdom to compare three doses of a hormonal intra-uterine device containing levonorgestrel and indomethacin with a device containing only levonorgestrel.

How does BAY98-7443 work?

BAY98-7443 is a hormonal intra-uterine device that combines levonorgestrel, a progestin, with indomethacin, a nonsteroidal anti-inflammatory drug. The levonorgestrel component thickens cervical mucus and thins the uterine lining to prevent fertilization, while indomethacin may reduce inflammation and improve tolerability.

Is BAY98-7443 the same as levonorgestrel?

BAY98-7443 is not the same as levonorgestrel alone. It is a combination product containing both levonorgestrel and indomethacin, designed as an intra-uterine device. The clinical trial compared this combination against a device containing only levonorgestrel to evaluate the added effect of indomethacin.