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Piroxicam

Phase 2

Contraception, Postcoital | Small molecule | Other |Bayer AG|Last Updated: Jul 10, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment72

FDA Designations

No designations recorded

Clinical trial landscape

Piroxicam · 1 trial · 1 indication

Phase 2 1
NCT01320709Effect of Piroxicam on OvulationContraception, Postcoital
COMPLETED72 Analytics
PHASE2COMPLETED
Effect of Piroxicam on Ovulation
Contraception, PostcoitalUnlock trial analytics

Study Endpoints

Primary Endpoints

Effect of piroxicam on ovulation (delay or inhibition) when given after the onset of LH surge
after 2 months

Secondary Endpoints

course of follicle sizes
after 2 months
course of gonadotropins (follicle-stimulating hormone [FSH], LH) and ovarian steroids (estradiol [E2], progesterone)
after 2 months
Concentration-times courses of piroxicam
after 2 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -
Arm 2EXPERIMENTAL -
Arm 3PLACEBO_COMPARATOR -
Arm 4EXPERIMENTAL -

Interventions

NameTypeDescription
Piroxicam ( BAYl1902)DRUGSingle dose of 20 mg piroxicam (i.e., 1 piroxicam capsule + 3 placebo capsule)
PlaceboDRUGSingle dose of placebo (i.e., 4 placebo capsules)
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Eligibility Criteria

Age Range18 Years to 35 Years
SexFEMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Signed informed consent available before any study specific tests or procedures are performed * Healthy female subject * Age: 18 to 35 years (inclusive) at the first screening visit * Body mass index (BMI ): 18-30 kg/m² (inclusive) at the first screening visit * Confirmation o...

Countries:Germany
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Frequently asked questions about Piroxicam

What is Piroxicam used for?

Piroxicam is being studied for use in postcoital contraception. It is an investigational small molecule in Phase 2 clinical development, evaluated in a completed trial of 72 healthy female participants in Germany. The drug is not approved for this use and remains under clinical investigation.

Who makes Piroxicam?

Piroxicam is being developed by Bayer AG, a company traded under the ticker BAYRY. The drug is currently in Phase 2 clinical development for postcoital contraception, with one completed trial involving 72 participants.

What phase is Piroxicam in?

Piroxicam is in Phase 2 clinical development. It is an investigational small molecule being studied for postcoital contraception. The drug has completed one Phase 2 trial, and it is not yet approved for any use.

What clinical trials is Piroxicam in?

Piroxicam has one completed clinical trial, NCT01320709, titled "Effect of Piroxicam on Ovulation." This Phase 2, randomized, double-blind, placebo-controlled study enrolled 72 healthy female participants aged 18 years and older in Germany. The trial evaluated the drug for postcoital contraception.

Is Piroxicam FDA approved?

Piroxicam is not FDA approved for postcoital contraception. It is an investigational drug in Phase 2 clinical development, with one completed trial. The drug has not been approved for any indication, and its safety and efficacy for this use are still being studied.