Delving into the Latest Updates on BAY-1007626 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Progestin IUS, BAY 1007626

Target

PR

Action

agonists

Mechanism

PR agonists(Progesterone receptor agonists)

Therapeutic Areas

Urogenital DiseasesOther Diseases

Active Indication-

Inactive Indication

ContraceptionPregnancy

Originator Organization

Bayer AG

Active Organization-

Inactive Organization

Bayer AG

Bayer HealthCare AG

License Organization-

Drug Highest PhaseDiscontinuedPhase 2

First Approval Date-

Regulation-

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Structure/Sequence

Molecular FormulaC23H32O2

InChIKeyCKSCPQVTRJRMNK-ZBAXIGARSA-N

CAS Registry1000371-89-0

Multi-center, Randomized, Comparator-controlled, Single-blind, Parallel-group Study to Investigate the Pharmacodynamics, Pharmacokinetics and Safety of an Intrauterine System Releasing BAY 1007626, as Compared With Mirena and Jaydess, in a Combined Proof-of-concept and Dose-finding Study in Healthy Pre Menopausal Women Treated for 90 Days

Investigation of pharmacological effects, drug blood levels and safety of an intrauterine system releasing the study drug BAY1007626 in comparison to Mirena and Jaydess in healthy young women treated for 90 days to determine the drug dose for further development

Start Date22 Jun 2015

Sponsor / Collaborator

Bayer AG

NCT00185380

/ CompletedPhase 2

Multi-center, Open, Randomized, Dose Finding Phase II Study to Investigate Ultra Low Dose Levonorgestrel Contraceptive Intrauterine Systems (LCS) Releasing Different Amounts of Levonorgestrel Compared to MIRENA in Nulliparous and Parous Women in Need of Contraception.

The purpose of this study is to investigate if drug doses lower than the one released from Mirena® would be as effective for contraception as Mirena®. Subjects participating in the study will be randomly assigned to be inserted with any of the three different intrauterine systems (IUSs). The IUSs are nearly alike except that the amount of hormone released from them is different.

Start Date01 Apr 2005

Sponsor / Collaborator

Bayer AG

100 Clinical Results associated with BAY-1007626

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100 Translational Medicine associated with BAY-1007626

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100 Patents (Medical) associated with BAY-1007626

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100 Deals associated with BAY-1007626

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Contraception	Phase 2	Finland	Bayer AG	01 Apr 2005
Contraception	Phase 2	Hungary	Bayer AG	01 Apr 2005
Contraception	Phase 2	Norway	Bayer AG	01 Apr 2005
Contraception	Phase 2	Sweden	Bayer AG	01 Apr 2005
Contraception	Phase 2	United Kingdom	Bayer AG	01 Apr 2005
Pregnancy	Phase 2	Germany	Bayer HealthCare AG	-
Pregnancy	Phase 2	Netherlands	Bayer HealthCare AG	-
Pregnancy	Phase 2	United Kingdom	Bayer HealthCare AG	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00185380 (CTgov)	Phase 2	Contraception	742	Levonorgestrel IUS (BAY86-5028, G04209B) (LCS12)	xzxtkydtxm(wheauojtth) = djzntuywfu midbzkyljv (ufergbdwmn, tjamvdkmxd - wytehzjyxm) View more	-	10 Mar 2010
				Levonorgestrel IUS (BAY86-5028, G04209C) (LCS16)	xzxtkydtxm(wheauojtth) = vhkheidxvx midbzkyljv (ufergbdwmn, hauoogyzbg - lqugvxwpwl) View more