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Estradiol Vaginal

Phase 3

Vulvovaginal Atrophy | Small molecule | Other |Novo Nordisk A/S|Last Updated: Feb 11, 2021

Success Probability

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Trial Design

RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment120

FDA Designations

No designations recorded

Clinical trial landscape

Estradiol Vaginal · 1 trial · 1 indication

Phase 3 1
NCT04232813Evaluation of the Acceptability and Efficacy of 10 Micrograms of Estradiol Vaginal Tablets vs Promestriene Vaginal CreamVulvovaginal Atrophy
COMPLETED120 Analytics
PHASE3COMPLETED
Evaluation of the Acceptability and Efficacy of 10 Micrograms of Estradiol Vaginal Tablets vs Promestriene Vaginal Cream
Vulvovaginal Atrophy
NCT04232813120
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Study Endpoints

Primary Endpoints

Vulvovaginal Symptoms
Change from Baseline, at week 4 and at week 12

Percentage of patients with vulvovaginal atrophy that accept 17B-Estradiol vaginal tablets vs promestriene vaginal cream after 12 weeks

Secondary Endpoints

Evaluation of relief of atrophic vaginitis symptoms using intensity ratings of none, mild, moderate or severe of dryness and dyspareunia.
Change from Baseline, at week 4 and at week 12
Evaluation of changes in ph.
Change from Baseline, at week 4 and at week 12
Evaluation of vaginal maturation index by Pap smear.
Change from Baseline, at week 4 and at week 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Estradiol 10 micrograms vaginal tabletsACTIVE_COMPARATOROne tablet intravaginally once daily for two weeks. Thereafter one tablet twice per week with at least a 3-days interval between treatments to maintain therapeutic response.
Promestriene 10mg./g vaginal creamACTIVE_COMPARATOROne application once daily intravaginally for two weeks. Thereafter one application twice per week with at least a 3-days interval between treatments to maintain therapeutic response.

Interventions

NameTypeDescription
Estradiol 10 MCG Vaginal Tablet [VAGIFEM]DRUGTo insert the tablets the patient must use the applicator provided in the way explained in the prospectus.
Promestriene VaginalDRUGTo insert the cream the patient must use the applicator provided in the way explained in the prospectus.
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Eligibility Criteria

Age Range45 Years to N/A
SexFEMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Postmenopausal women aged 45 years or older. Women will be considered postmenopausal with more than 12 months since last menstrual period * Women who have read and signed the Informed Consent Form * Women with an intact uterus * One or more vaginal symptoms (dryness, soreness,...

Countries:Spain
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Frequently asked questions about Estradiol Vaginal

What is Estradiol Vaginal used for?

Estradiol Vaginal is used for vulvovaginal atrophy, a condition involving thinning and inflammation of the vaginal walls due to decreased estrogen. It is a small molecule therapy being developed by Novo Nordisk A/S. The drug is currently in Phase 3 clinical development and remains investigational.

What does Estradiol Vaginal target?

Estradiol Vaginal is a form of estradiol, an estrogen hormone. It works by delivering estrogen locally to vaginal tissues to address vulvovaginal atrophy. The treatment is designed to restore the vaginal epithelium and relieve symptoms associated with estrogen deficiency.

Who makes Estradiol Vaginal?

Estradiol Vaginal is being developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker NVO. The drug is currently in Phase 3 clinical development for vulvovaginal atrophy.

What phase is Estradiol Vaginal in?

Estradiol Vaginal is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 3 trial has been completed, and the drug is being studied for vulvovaginal atrophy.

What clinical trials is Estradiol Vaginal in?

Estradiol Vaginal has one completed Phase 3 trial, identified as NCT04232813. This trial evaluated the acceptability and efficacy of 10 micrograms of estradiol vaginal tablets compared to promestriene vaginal cream in 120 female participants aged 45 years and older with vulvovaginal atrophy. The trial was conducted in Spain.

Is Estradiol Vaginal the same as estradiol vaginal tablets?

Estradiol Vaginal refers to the drug product being developed by Novo Nordisk. In clinical trials, it is administered as 10 microgram estradiol vaginal tablets. The active ingredient is estradiol, a form of estrogen used to treat vulvovaginal atrophy.