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

Primary Purpose

Atrophic Vaginitis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Generic Estradiol Vaginal Cream USP, 0.01%
Estrace® Vaginal Cream USP, 0.01%
Vehicle Vaginal Cream
Sponsored by
Actavis Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrophic Vaginitis

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Signed Informed Consent Form (ICF) that meets all criteria of current Food and Drug Administration (FDA) regulations.
  • Females aged 30-75 years inclusive who are postmenopausal, defined as follows:
  • At least 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) level of >40 milli-international units per milliliter (mIU/mL); at least 6 weeks post-surgical bilateral oophorectomy, with or without hysterectomy; or hysterectomy without oophorectomy if of age that the Investigator believes would have been naturally reached 12 months of spontaneous amenorrhea.
  • Vaginal pH >5.0.
  • At least 1 of the following participant self-assessed moderate to severe symptoms of vulvar and vaginal atrophy (VVA) from the following list that is identified by the participant as being most bothersome to her:

    1. Vaginal Dryness
    2. Vaginal and/or vulvar irritation/itching
    3. Dysuria
    4. Vaginal pain or bleeding associated with sexual activity, provided that participant is currently sexually active and plans to remain so throughout study.
  • "Normal" Screening mammogram completed within 9 months prior to Screening in all participants >40 years old.
  • Normal clinical breast examination at the Screening Visit.
  • Documented papanicolaou (PAP) smear conducted within the previous 12 months with no findings that the Investigator believes would contraindicate the use of topical vaginal estradiol.
  • Participants with an intact uterus should have vaginal ultrasonography results to confirm an inactive endometrial lining, defined as endometrial thickness less than 4 millimeters (mm).

Exclusion Criteria:

  1. Females younger than 30 years of age or older than 75 years of age.
  2. Participants with a Serum follicle-stimulating hormone (FSH) level of ≤40 mIU/mL at Screening.
  3. Greater than 5% superficial cells on vaginal cytology.
  4. Vaginal pH ≤5.
  5. Significant history or current evidence of chronic infectious disease, system disorder, organ disorder (including significant liver/kidney impairment) or other medical condition that in the Investigator's opinion would place the study participant at undue risk by participation or could jeopardize the integrity of the study evaluations.
  6. Participants with an intact uterus should have vaginal ultrasonography results to confirm an inactive endometrial lining. Participants with an endometrial thickness equal to or greater than 4 mm.
  7. Documented PAP smear conducted within the previous 12 months with findings that the Investigator believes would contraindicate the use of topical vaginal estradiol.
  8. Participants with known concurrent vaginal infections including but not limited to:

    Candida albicans, Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhea, or Gardnerella vaginalis.

  9. Participants with active vaginal herpes simplex infection or have had an outbreak within 30 days of the first dosing day.
  10. Participants with known, suspected, or current history of carcinoma of the breast. All participants over the age of 40 must have had a mammogram performed within 9 months of the study start and all participants will have a physical breast exam performed at Screening.
  11. Participants with known, suspected or current history of hormone dependent tumor.
  12. Participants with baseline systolic blood pressure of >150 millimetres of mercury (mmHg) and/or diastolic pressure >90 mmHg.
  13. Any participant with undiagnosed vaginal bleeding or significant risk factors for endometrial cancer.
  14. Any history of estrogen-dependent neoplasia (for example, endometrial cancer).
  15. History of acute thrombophlebitis or thromboembolic disorder.
  16. Any current or recent (within the previous 6 months) genital bleeding of unknown etiology.
  17. Any prescription treatment or over-the-counter (OTC) or natural remedies for vaginal dryness/irritation within 28 days of Screening. Products used for lubrication during sexual intercourse within 7 days of Screening.
  18. Participants whose fasting triglyceride levels are greater than 350 mg/dL.
  19. Any participant with a history of radiation therapy or recent (within previous 6 weeks) surgical therapy to the vaginal or cervical areas.
  20. Any known or suspected allergies that in the Investigator's opinion would compromise the safety of the participant.
  21. Participants who have used vaginal hormonal products (rings, creams, gels) within the 28 days prior to Screening.
  22. Any participant who has used transdermal estrogen and/or progestin therapy within the 28 days prior to Screening.
  23. Participants who have used oral estrogen and/ or progestin therapy or intrauterine progestin therapy within the 56 days prior to Screening.
  24. Participants who have used progestin implants or estrogen alone injectable drug therapy within the 3 months before Screening.
  25. Participants who have used estrogen pellet therapy or progestin injectable drug therapy within the 6 months before Screening.
  26. Participants who, in the opinion of the Investigator, would be non-compliant with the requirements of the study protocol.
  27. Participants who are unable or unwilling to give informed consent.
  28. Receipt of any drug as part of a research study within 30 days prior to Screening.
  29. Participants who have participated in this study previously.

Sites / Locations

  • Site Number 44
  • Site Number 17
  • Site Number 31
  • Site Number 11
  • Site Number 05
  • Site Number 15
  • Site Number 25
  • Site Number 01
  • Site Number 14
  • Site Number 18
  • Site Number 06
  • Site Number 13
  • Site Number 30
  • Site Number 27
  • Site Number 40
  • Site Number 20
  • Site Number 39
  • Site Number 38
  • Site Number 08
  • Site Number 03
  • Site Number 45
  • Site Number 19
  • Site Number 10
  • Site Number 02
  • Site Number 29
  • Site Number 22
  • Site Number 21
  • Site Number 33
  • Site Number 16
  • Site Number 34
  • Site Number 35
  • Site Number 12
  • Site Number 26
  • Site Number 36
  • Site Number 04
  • Site Number 37
  • Site Number 07
  • Site Number 24
  • Site Number 28
  • Site Number 23
  • Site Number 41
  • Site Number 43
  • Site Number 32
  • Site Number 09

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Generic Estradiol Vaginal Cream USP, 0.01%

Estrace Vaginal Cream USP, 0.01%

Vehicle Vaginal Cream

Arm Description

Participants were to self-administer 2 grams (g) of generic Estradiol Vaginal Cream USP, 0.01% once daily at approximately the same time of the day for 7 consecutive days.

Participants were to self-administer 2 g of Estrace Vaginal Cream USP, 0.01% once daily at approximately the same time of the day for 7 consecutive days.

Participants were to self-administer 2 g of vehicle vaginal cream once daily at approximately the same time of the day for 7 consecutive days.

Outcomes

Primary Outcome Measures

Number of Participants Identified as a Responder After Completing Study Treatment in the Generic Estradiol Vaginal Cream and Estrace Vaginal Cream Groups
Treatment comparison of the number of participants in the PP population that were identified as responders at the end of the treatment period evaluated on Day 8 + 1 is presented. A responder was defined as a participant with at least a 25% reduction from baseline in the sum of percent basal/parabasal + percent intermediate cells on vaginal cytology and vaginal pH ≤5.0 with a change from baseline vaginal pH of at least 0.5. Any participant who withdrew from the study because of lack of efficacy was included as a non-responder.
Number of Participants Identified as a Responder After Completing Study Treatment in the Generic Estradiol Vaginal Cream, Estrace Vaginal Cream, and Vehicle Vaginal Cream Groups
Treatment comparison of the number of participants in the mITT population that were identified as responders at the end of the treatment period evaluated on Day 8 + 1 is presented. A responder was defined as a participant with at least a 25% reduction from baseline in the sum of percent basal/parabasal + percent intermediate cells on vaginal cytology and vaginal pH ≤5.0 with a change from baseline vaginal pH of at least 0.5.

Secondary Outcome Measures

Number of Participants Identified as Treatment Success After Completing Study Treatment in the Generic Estradiol Vaginal Cream and Estrace Vaginal Cream Groups
The number of participants in the PP population that are identified as Treatment Success at the end of the treatment period evaluated on Day 8 ± 1 is presented. A Treatment Success is defined as a score of 0 or 1 at Day 8 ± 1 for the symptom identified at baseline as the most bothersome. This evaluation was based on participant self-assessed symptoms of vulvar and vaginal atrophy on a scale of 0 to 3 where 0 = none and 3 = severe. The symptoms that were evaluated were vaginal dryness, vaginal/vulvar irritation/itching, dysuria, vaginal pain associated with sexual activity, and vaginal bleeding. Any participant who withdrew from the study because of lack of efficacy was included as a non-responder.
Number of Participants Identified as Treatment Success After Completing Study Treatment in the Generic Estradiol Vaginal Cream, Estrace Vaginal Cream, and Vehicle Vaginal Cream Groups
The number of participants in the mITT Population that are identified as Treatment Success at the end of the treatment period evaluated on Day 8 ± 1 is presented. A Treatment Success is defined as a score of 0 or 1 at Day 8 ± 1 for the symptom identified at baseline as the most bothersome. This evaluation is to be based on participant self-assessed symptoms of vulvar and vaginal atrophy on a scale of 0 to 3 where 0 = none and 3 = severe. The symptoms that were evaluated were vaginal dryness, vaginal/vulvar irritation/itching, dysuria, vaginal pain associated with sexual activity, and vaginal bleeding.

Full Information

First Posted
September 20, 2017
Last Updated
December 11, 2019
Sponsor
Actavis Inc.
Collaborators
Teva Pharmaceuticals USA
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1. Study Identification

Unique Protocol Identification Number
NCT03294538
Brief Title
Study to Evaluate Equivalence of Estradiol Vaginal Cream 0.01% to Estrace® Cream 0.01% in Atrophic Vaginitis
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Study to Evaluate the Therapeutic Equivalence of Estradiol Vaginal Cream USP, 0.01% (Teva Pharmaceuticals, USA) to Estrace® Estradiol Vaginal Cream, USP, 0.01% (Warner Chilcott) in the Treatment of Atrophic Vaginitis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
May 18, 2016 (Actual)
Primary Completion Date
February 15, 2017 (Actual)
Study Completion Date
February 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Actavis Inc.
Collaborators
Teva Pharmaceuticals USA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The objectives of this study were to evaluate the therapeutic equivalence of the Test formulation, generic Estradiol Vaginal Cream United States Pharmacopoeia (USP), 0.01% (Teva Pharmaceuticals, United States of America) to the marketed product, Estrace® Cream estradiol vaginal cream USP, 0.01% (Warner Chilcott) in participants with atrophic vaginitis; to demonstrate the superiority of the Test and Reference (active) treatments over Placebo (vehicle) cream in participants with atrophic vaginitis; and to compare the safety of Test, Reference, and Placebo treatments in participants with atrophic vaginitis.
Detailed Description
Systemic (oral or transdermal patch administration) estrogen therapies have been shown to effectively treat symptoms of atrophic vaginitis but bear undesirable side effects including increased risk of heart attacks, stroke, endometrial cancer, and breast cancer. Topical therapies (creams and transvaginal delivery systems) provide low doses of estrogen to the vaginal mucosa to provide local relief for the symptoms of atrophic vaginitis, while reducing the unwanted side effects associated with systemic delivery systems. Low dose, topical estrogen therapy is considered most appropriate and convenient for the treatment of vaginal symptoms associated with menopause, particularly when other symptoms including bone loss or vasomotor dysfunction do not need to be targeted.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrophic Vaginitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
663 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Generic Estradiol Vaginal Cream USP, 0.01%
Arm Type
Experimental
Arm Description
Participants were to self-administer 2 grams (g) of generic Estradiol Vaginal Cream USP, 0.01% once daily at approximately the same time of the day for 7 consecutive days.
Arm Title
Estrace Vaginal Cream USP, 0.01%
Arm Type
Active Comparator
Arm Description
Participants were to self-administer 2 g of Estrace Vaginal Cream USP, 0.01% once daily at approximately the same time of the day for 7 consecutive days.
Arm Title
Vehicle Vaginal Cream
Arm Type
Placebo Comparator
Arm Description
Participants were to self-administer 2 g of vehicle vaginal cream once daily at approximately the same time of the day for 7 consecutive days.
Intervention Type
Drug
Intervention Name(s)
Generic Estradiol Vaginal Cream USP, 0.01%
Intervention Description
Vaginal cream, generic formulation of the brand product.
Intervention Type
Drug
Intervention Name(s)
Estrace® Vaginal Cream USP, 0.01%
Intervention Description
Vaginal cream, brand product.
Intervention Type
Drug
Intervention Name(s)
Vehicle Vaginal Cream
Intervention Description
Vaginal cream, placebo. Has no active ingredient
Primary Outcome Measure Information:
Title
Number of Participants Identified as a Responder After Completing Study Treatment in the Generic Estradiol Vaginal Cream and Estrace Vaginal Cream Groups
Description
Treatment comparison of the number of participants in the PP population that were identified as responders at the end of the treatment period evaluated on Day 8 + 1 is presented. A responder was defined as a participant with at least a 25% reduction from baseline in the sum of percent basal/parabasal + percent intermediate cells on vaginal cytology and vaginal pH ≤5.0 with a change from baseline vaginal pH of at least 0.5. Any participant who withdrew from the study because of lack of efficacy was included as a non-responder.
Time Frame
Up to Day 9
Title
Number of Participants Identified as a Responder After Completing Study Treatment in the Generic Estradiol Vaginal Cream, Estrace Vaginal Cream, and Vehicle Vaginal Cream Groups
Description
Treatment comparison of the number of participants in the mITT population that were identified as responders at the end of the treatment period evaluated on Day 8 + 1 is presented. A responder was defined as a participant with at least a 25% reduction from baseline in the sum of percent basal/parabasal + percent intermediate cells on vaginal cytology and vaginal pH ≤5.0 with a change from baseline vaginal pH of at least 0.5.
Time Frame
Up to Day 9
Secondary Outcome Measure Information:
Title
Number of Participants Identified as Treatment Success After Completing Study Treatment in the Generic Estradiol Vaginal Cream and Estrace Vaginal Cream Groups
Description
The number of participants in the PP population that are identified as Treatment Success at the end of the treatment period evaluated on Day 8 ± 1 is presented. A Treatment Success is defined as a score of 0 or 1 at Day 8 ± 1 for the symptom identified at baseline as the most bothersome. This evaluation was based on participant self-assessed symptoms of vulvar and vaginal atrophy on a scale of 0 to 3 where 0 = none and 3 = severe. The symptoms that were evaluated were vaginal dryness, vaginal/vulvar irritation/itching, dysuria, vaginal pain associated with sexual activity, and vaginal bleeding. Any participant who withdrew from the study because of lack of efficacy was included as a non-responder.
Time Frame
Up to Day 9
Title
Number of Participants Identified as Treatment Success After Completing Study Treatment in the Generic Estradiol Vaginal Cream, Estrace Vaginal Cream, and Vehicle Vaginal Cream Groups
Description
The number of participants in the mITT Population that are identified as Treatment Success at the end of the treatment period evaluated on Day 8 ± 1 is presented. A Treatment Success is defined as a score of 0 or 1 at Day 8 ± 1 for the symptom identified at baseline as the most bothersome. This evaluation is to be based on participant self-assessed symptoms of vulvar and vaginal atrophy on a scale of 0 to 3 where 0 = none and 3 = severe. The symptoms that were evaluated were vaginal dryness, vaginal/vulvar irritation/itching, dysuria, vaginal pain associated with sexual activity, and vaginal bleeding.
Time Frame
Up to 9 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed Informed Consent Form (ICF) that meets all criteria of current Food and Drug Administration (FDA) regulations. Females aged 30-75 years inclusive who are postmenopausal, defined as follows: At least 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) level of >40 milli-international units per milliliter (mIU/mL); at least 6 weeks post-surgical bilateral oophorectomy, with or without hysterectomy; or hysterectomy without oophorectomy if of age that the Investigator believes would have been naturally reached 12 months of spontaneous amenorrhea. Vaginal pH >5.0. At least 1 of the following participant self-assessed moderate to severe symptoms of vulvar and vaginal atrophy (VVA) from the following list that is identified by the participant as being most bothersome to her: Vaginal Dryness Vaginal and/or vulvar irritation/itching Dysuria Vaginal pain or bleeding associated with sexual activity, provided that participant is currently sexually active and plans to remain so throughout study. "Normal" Screening mammogram completed within 9 months prior to Screening in all participants >40 years old. Normal clinical breast examination at the Screening Visit. Documented papanicolaou (PAP) smear conducted within the previous 12 months with no findings that the Investigator believes would contraindicate the use of topical vaginal estradiol. Participants with an intact uterus should have vaginal ultrasonography results to confirm an inactive endometrial lining, defined as endometrial thickness less than 4 millimeters (mm). Exclusion Criteria: Females younger than 30 years of age or older than 75 years of age. Participants with a Serum follicle-stimulating hormone (FSH) level of ≤40 mIU/mL at Screening. Greater than 5% superficial cells on vaginal cytology. Vaginal pH ≤5. Significant history or current evidence of chronic infectious disease, system disorder, organ disorder (including significant liver/kidney impairment) or other medical condition that in the Investigator's opinion would place the study participant at undue risk by participation or could jeopardize the integrity of the study evaluations. Participants with an intact uterus should have vaginal ultrasonography results to confirm an inactive endometrial lining. Participants with an endometrial thickness equal to or greater than 4 mm. Documented PAP smear conducted within the previous 12 months with findings that the Investigator believes would contraindicate the use of topical vaginal estradiol. Participants with known concurrent vaginal infections including but not limited to: Candida albicans, Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhea, or Gardnerella vaginalis. Participants with active vaginal herpes simplex infection or have had an outbreak within 30 days of the first dosing day. Participants with known, suspected, or current history of carcinoma of the breast. All participants over the age of 40 must have had a mammogram performed within 9 months of the study start and all participants will have a physical breast exam performed at Screening. Participants with known, suspected or current history of hormone dependent tumor. Participants with baseline systolic blood pressure of >150 millimetres of mercury (mmHg) and/or diastolic pressure >90 mmHg. Any participant with undiagnosed vaginal bleeding or significant risk factors for endometrial cancer. Any history of estrogen-dependent neoplasia (for example, endometrial cancer). History of acute thrombophlebitis or thromboembolic disorder. Any current or recent (within the previous 6 months) genital bleeding of unknown etiology. Any prescription treatment or over-the-counter (OTC) or natural remedies for vaginal dryness/irritation within 28 days of Screening. Products used for lubrication during sexual intercourse within 7 days of Screening. Participants whose fasting triglyceride levels are greater than 350 mg/dL. Any participant with a history of radiation therapy or recent (within previous 6 weeks) surgical therapy to the vaginal or cervical areas. Any known or suspected allergies that in the Investigator's opinion would compromise the safety of the participant. Participants who have used vaginal hormonal products (rings, creams, gels) within the 28 days prior to Screening. Any participant who has used transdermal estrogen and/or progestin therapy within the 28 days prior to Screening. Participants who have used oral estrogen and/ or progestin therapy or intrauterine progestin therapy within the 56 days prior to Screening. Participants who have used progestin implants or estrogen alone injectable drug therapy within the 3 months before Screening. Participants who have used estrogen pellet therapy or progestin injectable drug therapy within the 6 months before Screening. Participants who, in the opinion of the Investigator, would be non-compliant with the requirements of the study protocol. Participants who are unable or unwilling to give informed consent. Receipt of any drug as part of a research study within 30 days prior to Screening. Participants who have participated in this study previously.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Teva Pharmaceuticals USA
Official's Role
Study Director
Facility Information:
Facility Name
Site Number 44
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Site Number 17
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Site Number 31
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Site Number 11
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Facility Name
Site Number 05
City
San Diego
State/Province
California
ZIP/Postal Code
91208
Country
United States
Facility Name
Site Number 15
City
San Diego
State/Province
California
ZIP/Postal Code
92111
Country
United States
Facility Name
Site Number 25
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80923
Country
United States
Facility Name
Site Number 01
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
Site Number 14
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Site Number 18
City
New London
State/Province
Connecticut
ZIP/Postal Code
06320
Country
United States
Facility Name
Site Number 06
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Site Number 13
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33461
Country
United States
Facility Name
Site Number 30
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Site Number 27
City
Miami
State/Province
Florida
ZIP/Postal Code
33015
Country
United States
Facility Name
Site Number 40
City
Miami
State/Province
Florida
ZIP/Postal Code
33130
Country
United States
Facility Name
Site Number 20
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Site Number 39
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Site Number 38
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Facility Name
Site Number 08
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Site Number 03
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Site Number 45
City
Port Saint Lucie
State/Province
Florida
ZIP/Postal Code
34952
Country
United States
Facility Name
Site Number 19
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
Site Number 10
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Site Number 02
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Site Number 29
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30075
Country
United States
Facility Name
Site Number 22
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Site Number 21
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67226
Country
United States
Facility Name
Site Number 33
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70001
Country
United States
Facility Name
Site Number 16
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49009
Country
United States
Facility Name
Site Number 34
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48604
Country
United States
Facility Name
Site Number 35
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
Site Number 12
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
Site Number 26
City
Plainsboro
State/Province
New Jersey
ZIP/Postal Code
08536
Country
United States
Facility Name
Site Number 36
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Site Number 04
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Site Number 37
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Site Number 07
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Site Number 24
City
Englewood
State/Province
Ohio
ZIP/Postal Code
45322
Country
United States
Facility Name
Site Number 28
City
West Chester
State/Province
Ohio
ZIP/Postal Code
45069
Country
United States
Facility Name
Site Number 23
City
Bluffton
State/Province
South Carolina
ZIP/Postal Code
29910
Country
United States
Facility Name
Site Number 41
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Site Number 43
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Site Number 32
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Site Number 09
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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