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Oxybutynin chloride

Phase 2FDA approved

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

Oxybutynin chloride development status

FDA approval on record Dec 16, 1998
Approval holderJanssen Pharms
ApplicationNDA020897
Highest phase Phase 2
Registered trials 1 across 1 sponsor since Oct 2009

Oxybutynin chloride target and mechanism

Molecular targetCHRM2, CHRM3
Target classAntagonist
ModalitySmall molecule

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

Oxybutynin chloride clinical trials

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, such as hot flashes, in healthy post-menopausal women. It is an investigational use for this small molecule, which is also known for other indications. The Phase 2 trial NCT00990886 evaluated its effect on these symptoms in women aged 40 years and older.

What does oxybutynin chloride target?

Oxybutynin chloride targets the muscarinic acetylcholine receptors CHRM2 and CHRM3. It acts as an antagonist at these receptors, blocking acetylcholine signaling. This mechanism is relevant to its investigational use for menopause-related vasomotor symptoms.

Who is developing oxybutynin chloride for menopause?

Johnson & Johnson, ticker JNJ, is the developer of oxybutynin chloride for menopause. The company is responsible for the clinical development program in this indication.

What phase is oxybutynin chloride in for menopause?

Oxybutynin chloride is in Phase 2 development for menopause. It is investigational and has not been approved for this indication. The Phase 2 trial has been completed.

What clinical trials is oxybutynin chloride in for menopause?

Oxybutynin chloride has been studied in one completed Phase 2 trial, NCT00990886, titled 'The Effect of Extended-Release Oxybutynin Chloride on Vasomotor Symptoms in Healthy Post-Menopausal Women.' The trial enrolled 148 participants, was randomized, double-blind, and placebo-controlled, and included women aged 40 years and older.