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YAZ flex

Phase 3

Primary Dysmenorrhea | Small molecule | Other |Bayer AG|Last Updated: Oct 29, 2014

Target and mechanism

ModalitySmall molecule

Also known as Drug: YAZ flex (SH T00186D), Drug: YAZ flex

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment223

FDA Designations

No designations recorded

Clinical trial landscape

YAZ flex · 1 trial · 1 indication

Phase 3 1
NCT00569244SH T00186 in the Treatment of Primary DysmenorrheaPrimary Dysmenorrhea
COMPLETED223 Analytics
PHASE3COMPLETED
SH T00186 in the Treatment of Primary Dysmenorrhea
Primary Dysmenorrhea
NCT00569244223
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Study Endpoints

Primary Endpoints

Number of days with dysmenorrheic pain
140 days

Secondary Endpoints

Use of rescue medication
140 days
Interference with daily activity
140 days
Number of days: with at least moderate dysmenorrheic pain
140 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -
Arm 2ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Drug: YAZ flex (SH T00186D)DRUGExtended flexible regimen of YAZ (SH T00186D); triggered by bleeding events(Tablet p.o. (oral))
YAZ (SH T00186D)DRUGYAZ (SH T 00186D) administered in the conventional regimen (24 days active + 4 days placebo) (Tablet p.o. (oral))
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Eligibility Criteria

Age Range18 Years to 40 Years
SexFEMALE
Healthy VolunteersNo
Study Sites27

Inclusion Criteria: * Otherwise healthy female patients with moderate to severe primary dysmenorrhea * Prospective self-rated sum pain score of \>/= 8 during the 2 baseline cycles * Age between 18 and 40 years (inclusive) with smoking habits as follows: * between 18 and 30 years of age. daily ci...

Countries:GermanyUnited Kingdom
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