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Synthetic Conjugated estrogens, B

Phase 3

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

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 used for?

Synthetic Conjugated estrogens, B is used for the treatment of vulvovaginal atrophy in menopausal women. It is a small molecule being developed by Teva Pharmaceutical Industries Limited for the endocrine condition of menopause. The drug is currently in Phase 3 clinical development.

What does Synthetic Conjugated estrogens, B target?

Synthetic Conjugated estrogens, B is a synthetic conjugated estrogen. It works by replacing or supplementing estrogen hormones in the body to treat symptoms associated with menopause, such as vulvovaginal atrophy. The drug is designed to provide estrogenic effects to alleviate these menopausal symptoms.

Who makes Synthetic Conjugated estrogens, B?

Synthetic Conjugated estrogens, B is being developed by Teva Pharmaceutical Industries Limited, a company traded under the ticker TEVA. The drug is currently in Phase 3 clinical trials for the treatment of vulvovaginal atrophy in menopausal women.

What phase is Synthetic Conjugated estrogens, B in?

Synthetic Conjugated estrogens, B is in Phase 3 clinical development. It is an investigational drug, not yet approved by regulatory authorities. A Phase 3 trial has been completed to evaluate its safety and efficacy for treating vulvovaginal atrophy in menopausal women.

What clinical trials is Synthetic Conjugated estrogens, B in?

Synthetic Conjugated estrogens, B has one completed Phase 3 clinical trial, identified as NCT00196378. This randomized, double-blind, placebo-controlled study evaluated the safety and efficacy of Enjuvia 0.3 mg for vulvovaginal atrophy in 300 menopausal women in the United States.

Is Synthetic Conjugated estrogens, B the same as Enjuvia?

Yes, Synthetic Conjugated estrogens, B is also known as Enjuvia. The Phase 3 clinical trial NCT00196378 evaluated Enjuvia 0.3 mg for the treatment of vulvovaginal atrophy, confirming that Enjuvia is the brand name for this synthetic conjugated estrogen product.