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Synthetic Conjugated estrogens, B

Phase 3

Menopause | Small molecule | Endocrine |Teva Pharmaceutical Industries Limited|Last Updated: Sep 2, 2013

Target and mechanism

Molecular targetESR2, ESR1
Target classAgonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment300

FDA Designations

No designations recorded

Clinical trial landscape

Synthetic Conjugated estrogens, B · 1 trial · 1 indication

Phase 3 1
NCT00196378A Clinical Trial to Evaluate the Safety and Efficacy of Enjuvia 0.3 mg for the Treatment of Vulvovaginal AtrophyMenopause
COMPLETED300 Analytics
PHASE3COMPLETED
A Clinical Trial to Evaluate the Safety and Efficacy of Enjuvia 0.3 mg for the Treatment of Vulvovaginal Atrophy
MenopauseUnlock trial analytics

Study Endpoints

Primary Endpoints

Mean change in the symptom identified by the patient to be most bothersome
Randomization to Week 12
Mean change in vaginal pH
Randomization to Week 12
Mean change in maturation index
Randomization to Week 12

Secondary Endpoints

Safety and tolerability of Enjuvia
Duration of study
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
Synthetic Conjugated estrogens, BDRUG1 (0.3mg) tablet daily
PlaceboOTHER1 tablet daily
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Eligibility Criteria

Age Range30 Years to 80 Years
SexFEMALE
Healthy VolunteersNo
Study Sites38

Inclusion Criteria: * Naturally or surgically postmenopausal * Moderate or severe symptoms of vaginal atrophy (ie, dryness, itching, pain, uncomfortable intercourse) Exclusion Criteria: * Known sensitivity or contraindication to estrogens or progestins * History or current diagnosis of endometria...

Countries:United States
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Frequently asked questions about Synthetic Conjugated estrogens, B

What is Synthetic Conjugated estrogens, B?

Synthetic Conjugated estrogens, B is a small molecule estrogen therapy developed by Teva Pharmaceutical Industries Limited for the treatment of menopause. It is an investigational product in Phase 3 clinical development. It is designed as an agonist of the estrogen receptors ESR1 and ESR2.

What is Synthetic Conjugated estrogens, B used for?

Synthetic Conjugated estrogens, B is being developed for the treatment of menopause. The Phase 3 clinical trial evaluated it for vulvovaginal atrophy, a common condition associated with menopause. It is not yet approved and remains under clinical investigation.

What does Synthetic Conjugated estrogens, B target?

Synthetic Conjugated estrogens, B targets the estrogen receptors ESR1 and ESR2. It acts as an agonist at these receptors, meaning it activates them to produce estrogen-like effects. This mechanism underlies its development for menopause-related conditions.

Who makes Synthetic Conjugated estrogens, B?

Synthetic Conjugated estrogens, B is developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva is the sponsor responsible for the clinical development of this asset.

What phase is Synthetic Conjugated estrogens, B in?

Synthetic Conjugated estrogens, B is in Phase 3 clinical development. The single Phase 3 trial has been completed, and no active trials are currently listed. It is an investigational therapy and has not been approved for any indication.

What clinical trials is Synthetic Conjugated estrogens, B in?

Synthetic Conjugated estrogens, B has been studied in one Phase 3 clinical trial, NCT00196378, titled A Clinical Trial to Evaluate the Safety and Efficacy of Enjuvia 0.3 mg for the Treatment of Vulvovaginal Atrophy. The trial was completed, enrolled 300 participants, and was randomized, double-blind, and placebo-controlled.