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YAZ flex

Phase 3

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

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

YAZ flex clinical trials

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 DysmenorrheaUnlock trial analytics

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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Frequently asked questions about YAZ flex

What is YAZ flex used for?

YAZ flex is being developed for the treatment of primary dysmenorrhea, a condition characterized by painful menstrual cramps. It is an investigational small molecule therapy studied in adult women aged 18 years and older. The clinical program has focused specifically on this indication rather than broader gynecological conditions.

Who makes YAZ flex?

YAZ flex is developed by Bayer AG, which trades under the ticker BAYRY. Bayer is the sponsor of the clinical program evaluating the drug in primary dysmenorrhea. The company conducted the Phase 3 trial of YAZ flex in Germany and the United Kingdom.

What phase is YAZ flex in?

YAZ flex is in Phase 3 clinical development. One Phase 3 trial has been completed, and no active trials are currently listed. The drug remains investigational and has not been approved by the FDA for any indication based on the available development data.

What clinical trials is YAZ flex in?

YAZ flex has been evaluated in one completed Phase 3 trial, NCT00569244, titled SH T00186 in the Treatment of Primary Dysmenorrhea. The trial enrolled 223 participants across Germany and the United Kingdom, was randomized, active-controlled, and restricted to female participants aged 18 years and older.

Is YAZ flex the same as SH T00186D?

Yes, YAZ flex is also known as SH T00186D. These names refer to the same investigational drug developed by Bayer AG for primary dysmenorrhea. The Phase 3 trial NCT00569244 used the SH T00186 designation in its title, confirming the connection between the two names.