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Atrophic Vaginitis

5
Pipeline Programs
5
Companies
7
Clinical Trials
1 recruiting
1
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
1
0
0
0
3
1
Early DiscoveryClinical DevelopmentMarket

On Market (1)

Approved therapies currently available

Viatris
ELESTRINApproved
estradiol
Viatris
Estrogen [EPC]transdermal2006
179K Part D

Competitive Landscape

5 companies ranked by most advanced pipeline stage

Viatris
ViatrisCANONSBURG, PA
1 program
1
1
Estradiol Vaginal Cream, 0.01%Phase 31 trial
Active Trials
NCT02195986Completed366Est. Dec 2014
Pfizer
PfizerNEW YORK, NY
2 programs
1
1
PVCPhase 31 trial
Premarin® Vaginal CreamPhase 11 trial
Active Trials
NCT00167921Completed24
NCT00137371Completed480Est. Sep 2007
Alvogen
AlvogenNJ - Morristown
1 program
1
estradiolPhase 31 trial
Active Trials
NCT02995694Completed535Est. Dec 2016
Stratpharma
StratpharmaSwitzerland - Basel
2 programs
7-0940N/A1 trial
Film forming silicone gelN/A1 trial
Active Trials
NCT05953090Recruiting2,000Est. Dec 2028
NCT05432154Completed10Est. Jul 2022
Teva
TevaIsrael - Petach Tikva
1 program
Generic Estradiol Vaginal Cream USP, 0.01%PHASE_31 trial
Active Trials
NCT03294538Completed663Est. Feb 2017

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
TevaGeneric Estradiol Vaginal Cream USP, 0.01%
Alvogenestradiol
ViatrisEstradiol Vaginal Cream, 0.01%
PfizerPVC
PfizerPremarin® Vaginal Cream
Stratpharma7-0940
StratpharmaFilm forming silicone gel

Clinical Trials (7)

Total enrollment: 4,078 patients across 7 trials

NCT03294538TevaGeneric Estradiol Vaginal Cream USP, 0.01%

Study to Evaluate Equivalence of Estradiol Vaginal Cream 0.01% to Estrace® Cream 0.01% in Atrophic Vaginitis

Start: May 2016Est. completion: Feb 2017663 patients
Phase 3Completed
NCT02995694Alvogenestradiol

A Study Comparing Estradiol Vaginal Cream to Estrace® Cream in Females With Atrophic Vaginitis

Start: Mar 2016Est. completion: Dec 2016535 patients
Phase 3Completed
NCT02195986ViatrisEstradiol Vaginal Cream, 0.01%

A Comparison of Estradiol Vaginal Cream to Estrace® Cream in 350 Postmenopausal Females With Atrophic Vaginitis

Start: Jun 2014Est. completion: Dec 2014366 patients
Phase 3Completed
NCT00137371PfizerPVC

Study Evaluating Conjugated Estrogen Cream for Atrophic Vaginitis

Start: Aug 2005Est. completion: Sep 2007480 patients
Phase 3Completed
NCT00167921PfizerPremarin® Vaginal Cream

Study Comparing Premarin® Vaginal Cream Versus Premarin® Oral Tablets in Atrophic Vaginitis

Start: Oct 200524 patients
Phase 1Completed
NCT05953090Stratpharma7-0940

VALOR: Vaginal Atrophy & Long-term Observation of Recovery

Start: Oct 2023Est. completion: Dec 20282,000 patients
N/ARecruiting
NCT05432154StratpharmaFilm forming silicone gel

An Innovative Silicone Wound Dressing for the Management of Atrophic Vaginitis

Start: Apr 2022Est. completion: Jul 202210 patients
N/ACompleted

Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

3 late-stage (Phase 3) programs, potential near-term approvals
1 actively recruiting trials targeting 4,078 patients
5 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.