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Synthetic Conjugated estrogens, B

Phase 3FDA approved 2004

Menopause | Small Molecules | Endocrine |Teva Pharmaceutical Industries Limited|Trials Updated: Sep 2, 2013

Synthetic Conjugated estrogens, B development status

FDA approval Dec 20, 2004 as Enjuvia
Approval holderDuramed
ApplicationNDA021609
Highest phase Phase 3

Synthetic Conjugated estrogens, B target and mechanism

Molecular targetESR2, ESR1
Target classAgonist
ModalitySmall Molecules

Also known as Enjuvia

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment300

FDA Designations

No designations recorded

Synthetic Conjugated estrogens, B clinical trials

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 to treat menopause-related conditions, specifically vulvovaginal atrophy. It is a small molecule estrogen therapy developed by Teva Pharmaceutical Industries Limited. The Phase 3 program evaluated a 0.3 mg dose in postmenopausal women aged 30 years and older in the United States.

What does Synthetic Conjugated estrogens, B target?

Synthetic Conjugated estrogens, B targets the estrogen receptors ESR1 and ESR2 as an agonist. By activating these receptors, the drug produces estrogenic effects relevant to menopausal symptoms such as vulvovaginal atrophy. Both receptors are members of the nuclear receptor family that mediate estrogen signaling in reproductive and other tissues.

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 of the clinical program for this estrogen therapy in menopause.

What phase is Synthetic Conjugated estrogens, B in?

Synthetic Conjugated estrogens, B is in Phase 3 development. The single registered trial, NCT00196378, has been completed. The drug is investigational and is not described as approved. The Phase 3 study was randomized, double-blind, and placebo-controlled, enrolling 300 female participants.

What clinical trials is Synthetic Conjugated estrogens, B in?

Synthetic Conjugated estrogens, B has been studied in one 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 Phase 3 trial is completed, enrolled 300 participants, and was conducted 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 trial NCT00196378 evaluated Enjuvia 0.3 mg for the treatment of vulvovaginal atrophy in menopausal women. Enjuvia is the brand name used for this Teva Pharmaceutical Industries Limited product.