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Oxybutynin chloride

Phase 2

Menopause | Small molecule | Endocrine |Johnson & Johnson|Last Updated: Dec 12, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment148

FDA Designations

No designations recorded

Clinical trial landscape

Oxybutynin chloride · 1 trial · 2 indications

Phase 2 1
NCT00990886The Effect of Extended-Release Oxybutynin Chloride on Vasomotor Symptoms in Healthy Post-Menopausal WomenMenopause
COMPLETED148 Analytics
PHASE2COMPLETED
The Effect of Extended-Release Oxybutynin Chloride on Vasomotor Symptoms in Healthy Post-Menopausal Women
MenopauseUnlock trial analytics

Study Endpoints

Primary Endpoints

The co-primary endpoints in this study are the change in daily frequency of moderate to severe hot flashes from baseline to Week 12 and the change in severity of moderate to severe hot flashes from baseline to Week 12.
Week 12 in the study corresponds to visit 6 that is scheduled from day 78 to day 84.

Secondary Endpoints

Change in daily frequency of moderate to severe hot flashes from baseline to Week 4 and 12
Weeks 4 and 12
Change in severity of moderate to severe hot flashes from baseline to Week 4 and 12
Weeks 4 and 12
Change of daily composite score of moderate to severe hot flashes from baseline to Week 4 and Week 12
Weeks 4 and 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
001EXPERIMENTALOxybutynin chloride 15 mg once daily for 12 weeks
002PLACEBO_COMPARATORPlacebo Once daily for 12 weeks

Interventions

NameTypeDescription
PlaceboDRUGOnce daily for 12 weeks
Oxybutynin chlorideDRUG15 mg once daily for 12 weeks
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Eligibility Criteria

Age Range40 Years to 65 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Patients must be in good health * Must be naturally postmenopausal and have not experienced menses for at least 6 months prior to the start of the study * Must have serum FSH levels \> 40 mIU/mL * Must average seven or more moderate to severe hot flushes with sweating per day,...

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Frequently asked questions about Oxybutynin chloride

What is Oxybutynin chloride used for in menopause?

Oxybutynin chloride is being studied for the treatment of vasomotor symptoms, commonly known as hot flashes, in healthy post-menopausal women. It is an investigational small molecule in Phase 2 clinical development for this indication, and it has not been approved for this use.

Who makes Oxybutynin chloride?

Oxybutynin chloride is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The company is conducting clinical research to evaluate the drug's effects on menopausal symptoms.

What phase is Oxybutynin chloride in?

Oxybutynin chloride is in Phase 2 clinical development for the treatment of vasomotor symptoms in post-menopausal women. It is an investigational drug, meaning it has not yet been approved by regulatory authorities for this indication.

What clinical trials is Oxybutynin chloride in?

Oxybutynin chloride has one completed clinical trial, identified as NCT00990886. This Phase 2 study evaluated the effect of extended-release oxybutynin chloride on vasomotor symptoms in healthy post-menopausal women, enrolling 148 participants.

How does Oxybutynin chloride work?

Oxybutynin chloride is an anticholinergic agent that works by blocking the action of acetylcholine on muscarinic receptors. This mechanism is thought to help reduce the frequency and severity of hot flashes in post-menopausal women.