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

PHASE3CompletedINTERVENTIONAL
Enrollment

663

Participants

Timeline

Start Date

May 18, 2016

Primary Completion Date

February 15, 2017

Study Completion Date

February 15, 2017

Conditions
Atrophic Vaginitis
Interventions
DRUG

Generic Estradiol Vaginal Cream USP, 0.01%

Vaginal cream, generic formulation of the brand product.

DRUG

Estrace® Vaginal Cream USP, 0.01%

Vaginal cream, brand product.

DRUG

Vehicle Vaginal Cream

Vaginal cream, placebo. Has no active ingredient

Trial Locations (44)

27103

Site Number 04, Winston-Salem

Site Number 37, Winston-Salem

27607

Site Number 36, Raleigh

29464

Site Number 41, Mt. Pleasant

29572

Site Number 43, Myrtle Beach

29910

Site Number 23, Bluffton

30075

Site Number 29, Roswell

31406

Site Number 22, Savannah

32174

Site Number 03, Ormond Beach

33014

Site Number 30, Miami Lakes

33015

Site Number 27, Miami

33130

Site Number 40, Miami

33136

Site Number 20, Miami

33144

Site Number 39, Miami

33186

Site Number 38, Miami

33409

Site Number 02, West Palm Beach

33458

Site Number 06, Jupiter

33461

Site Number 13, Lake Worth

33709

Site Number 19, St. Petersburg

34239

Site Number 10, Sarasota

34652

Site Number 08, New Port Richey

34952

Site Number 45, Port Saint Lucie

43213

Site Number 07, Columbus

45069

Site Number 28, West Chester

45322

Site Number 24, Englewood

48604

Site Number 34, Saginaw

49009

Site Number 16, Kalamazoo

67226

Site Number 21, Wichita

68510

Site Number 35, Lincoln

70001

Site Number 33, Metairie

75230

Site Number 32, Dallas

80209

Site Number 01, Denver

80220

Site Number 14, Denver

80923

Site Number 25, Colorado Springs

85710

Site Number 44, Tucson

85712

Site Number 17, Tucson

91208

Site Number 05, San Diego

91942

Site Number 31, La Mesa

92111

Site Number 15, San Diego

95821

Site Number 11, Sacramento

98105

Site Number 09, Seattle

06320

Site Number 18, New London

08648

Site Number 12, Lawrenceville

08536

Site Number 26, Plainsboro

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Teva Pharmaceuticals USA

INDUSTRY

lead

Actavis Inc.

INDUSTRY

NCT03294538 - Study to Evaluate Equivalence of Estradiol Vaginal Cream 0.01% to Estrace® Cream 0.01% in Atrophic Vaginitis | Biotech Hunter | Biotech Hunter