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Cenestin

Phase 3

Hot Flashes | Small molecule | Endocrine |Teva Pharmaceutical Industries Limited|Last Updated: Jul 3, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment400

FDA Designations

No designations recorded

Clinical trial landscape

Cenestin · 1 trial · 1 indication

Phase 3 1
NCT00272935A Clinical Trial to Demonstrate the Efficacy and Safety of Cenestin 0.3 mg for the Treatment of Hot FlashesHot Flashes
COMPLETED400 Analytics
PHASE3COMPLETED
A Clinical Trial to Demonstrate the Efficacy and Safety of Cenestin 0.3 mg for the Treatment of Hot Flashes
Hot FlashesUnlock trial analytics

Study Endpoints

Primary Endpoints

Mean change in average frequency of moderate to severe hot flashes
Baseline to Day 28 and to Day 84
Mean change in severity of moderate to severe hot flashes
Baseline to Day 28 and to Day 84

Secondary Endpoints

Safety and tolerability of Cenestin 0.3mg
Throughout study
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
Cenestin 0.3 mg TabletsDRUG1 tablet daily
PlaceboOTHER1 tablet daily
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Eligibility Criteria

Age Range30 Years to 80 Years
SexFEMALE
Healthy VolunteersNo
Study Sites49

Inclusion Criteria: * Naturally or surgically postmenopausal * At least 12 months since last menses or 6 weeks past surgery * Minimum of 7 daily or 50 weekly moderate to severe hot flashes Exclusion Criteria: * Any contraindication to natural or synthetic estrogens

Countries:United States
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Frequently asked questions about Cenestin

What is Cenestin used for?

Cenestin is a small molecule drug being developed for the treatment of hot flashes, a symptom commonly associated with menopause. It is an investigational therapy that has been studied in a clinical trial setting, though it is not yet approved for this use.

Who makes Cenestin?

Cenestin is being developed by Teva Pharmaceutical Industries Limited, a company publicly traded under the ticker symbol TEVA. Teva is responsible for the clinical development of this drug candidate for the treatment of hot flashes.

What phase is Cenestin in?

Cenestin is in Phase 3 clinical development. It has completed a Phase 3 trial, but it remains an investigational drug and has not been approved by regulatory authorities for the treatment of hot flashes.

What clinical trials is Cenestin in?

Cenestin has been studied in a completed Phase 3 clinical trial registered as NCT00272935. This trial, titled "A Clinical Trial to Demonstrate the Efficacy and Safety of Cenestin 0.3 mg for the Treatment of Hot Flashes," enrolled 400 female participants aged 30 years and older in the United States.

Is Cenestin a randomized controlled trial drug?

Yes, the Phase 3 clinical trial for Cenestin was a randomized, double-blind, placebo-controlled study. This design was used to evaluate the efficacy and safety of Cenestin 0.3 mg for the treatment of hot flashes in the 400 enrolled participants.