Study Comparing Estradiol Vaginal Inserts 4mcg To IMVEXXY ® (Estradiol Vaginal Inerts 4 mcg) In The Treatment Of Dyspareunia in Women With Vulvur and Vaginal Atrophy

PHASE3CompletedINTERVENTIONAL
Enrollment

1,050

Participants

Timeline

Start Date

November 15, 2022

Primary Completion Date

March 15, 2024

Study Completion Date

March 15, 2024

Conditions
Dyspareunia
Interventions
DRUG

Estradiol

Vaginal Insert, 4 mcg tablet

DRUG

Imvexxy

Estradiol 4 mcg Vaginal Insert

DRUG

Placebo

Vehicle Vaginal Insert

Trial Locations (48)

15241

Site 10102, Upper Saint Clair

19114

Site 10134, Philadelphia

23502

Site 10108, Norfolk

28562

Site 10137, New Bern

Site 10145, New Bern

29405

Site 10110, North Charleston

30093

Site 10113, Norcross

32132

Site 10130, Edgewater

32174

Site 10129, Ormond Beach

32751

Site 10138, Maitland

33014

Site 10107, Miami Lakes

Site 10144, Miami Lakes

33166

Site 10101, Miami Springs

33351

Site 10123, Hialeah

Site 10121, Sunrise

33409

Site 10119, West Palm Beach

33461

Site 10139, Lake Worth

33614

Site 10140, Tampa

34239

Site 10117, Sarasota

34652

Site 10106, New Port Richey

34677

Site 10143, Oldsmar

34684

Site 10116, Palm Harbor

34748

Site 10115, Leesburg

35218

Site 10112, Birmingham

37404

Site 10118, Chattanooga

67226

Site 10104, Wichita

70001

Site 10109, Metairie

70072

Site 10128, Marrero

70127

Site 10122, New Orleans

76104

Site 10120, Fort Worth

77022

Site 10141, Houston

77701

Site 10142, Beaumont

85224

Site 10146, Chandler

89030

Site 10147, North Las Vegas

89128

Site 10111, Las Vegas

92111

Site 10135, San Diego

95821

Site 10103, Sacramento

Site 10124, Sacramento

Site 10105, Saginaw

98105

Site 10154, Seattle

06460

Site 10136, Milford

08648

Site 10126, Lawrenceville

CP 01501

Site 10148, Santa Tecla

CP 01101

Site 10149, San Salvador

CP 21102

Site 10151, San Pedro Sula

CP 21104

Site 10153, San Pedro Sula

CP21104

Site 10150, San Pedro Sula

Unknown

Site 10152, San Pedro Sula

All Listed Sponsors
lead

Teva Pharmaceuticals USA

INDUSTRY