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Cenestin

Phase 3

Hot Flashes | Small molecule | Endocrine |Teva Pharmaceutical Industries Limited|Trials 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

Cenestin clinical trials

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 used to treat hot flashes. It is a small molecule therapy in the endocrine therapeutic area, developed by Teva Pharmaceutical Industries Limited. The drug has been studied in a Phase 3 clinical trial for the treatment of hot flashes in women.

Who makes Cenestin?

Cenestin is made by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva is the developer responsible for the clinical program evaluating Cenestin for hot flashes.

What phase is Cenestin in?

Cenestin is in Phase 3 clinical development for hot flashes. The program includes one completed Phase 3 trial. As an investigational therapy, Cenestin has not been established as approved for this use based on the available development information.

What clinical trials is Cenestin in?

Cenestin has been evaluated in one clinical trial: NCT00272935, titled A Clinical Trial to Demonstrate the Efficacy and Safety of Cenestin 0.3 mg for the Treatment of Hot Flashes. This Phase 3 trial was completed, enrolled 400 participants, and was conducted in the United States.

What was the design of the Cenestin clinical trial?

The Phase 3 trial NCT00272935 was a randomized, double-blind, placebo-controlled study of Cenestin 0.3 mg for hot flashes. It enrolled 400 female participants aged 30 years and older in the United States and has been completed.