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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

Primary Purpose

Dyspareunia

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Estradiol
Imvexxy
Placebo
Sponsored by
Teva Pharmaceuticals USA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyspareunia

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Signed, IRB approved informed consent that meets all criteria of current FDA and local regulations. Females aged 40-75 years inclusive who are postmenopausal, with at least: 12 months of spontaneous amenorrhea (women <55 year of age with history of hysterectomy without bilateral oophorectomy prior to natural menopause must have Serum follicle-stimulating hormone (FSH) level > 40 mIU/mL); or 6 months of spontaneous amenorrhea with FSH levels >40mIU/mL; or At least 6 weeks postsurgical bilateral oophorectomy Have less than or equal to 5% superficial cells on vaginal cytological smear. Vaginal pH > 5.0. Moderate to severe symptom of vaginal pain associated with sexual activity considered the most bothersome vaginal symptom (dyspareunia) of VVA by the patient at screening visit. (i.e., a VVA Symptom Self-Assessment Questionnaire score of 2 or 3) (Appendix B). Women should be sexually active (for example, have sexual activity with vaginal penetration within approximately one month of screening visit). Women should anticipate having sexual activity (with vaginal penetration) during the conduct of the study, and agree to at least one episode of sexual intercourse within study days 10-13. Baseline systolic blood pressure should be no greater than 150 mm Hg and diastolic blood pressure no greater than 90 mm Hg. Normal mammogram completed within 9 months before randomization and a normal clinical breast examination prior to randomization in the study. Patients who have underwent complete Hysterectomy, or in the case of patients with an intact uterus (including patients who underwent a partial hysterectomy) the later must have: A documented papanicolaou (PAP) smear conducted within 12 months before randomization with no findings that the Investigator believes would contraindicate the use of topical vaginal estradiol. Documented vaginal ultrasonography results within 3 months before randomization to confirm an inactive endometrial lining, defined as endometrial thickness <4mm. In the opinion of the Investigator, the patient will comply with the protocol and has a high probability of completing the study. Exclusion Criteria: Premenopasual, perimenopausal, pregnant or lactating patient or planning a pregnancy. Significant history or current evidence of chronic infectious disease, system disorder, organ disorder or other medical condition that in the Investigator's opinion would place the study patient at undue risk by participation or could jeopardize the integrity of the study evaluations. Any clinically significant laboratory finding that, in the Investigator's opinion would contraindicate the use of estradiol or compromise patients' safety. Significant history of cholestatic jaundice, hypertension, coronary heart disease or other serious heart problems, uncontrolled diabetes, hypercholesterolemia, hypercalcemia, hypoparathyroidism, hypertriglyceridemia, systemic lupus erythematosus, renal impairment, residual endometriosis posthysterectomy, asthma, epilepsy, migraine, porphyria, hepatic hemangiomas that in the Investigator's opinion would place the study patient at undue risk by participation or could jeopardize the integrity of the study evaluations. History of Protein C, Protein S, or antithrombin deficiency, or other thrombophilic disorder. Patients with known concurrent vaginal infections including but not limited to: Candida albicans, Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhea or Gardnerella vaginalis. Patients with active vaginal herpes simplex infection or have had an outbreak within 40 days before Screening History of sexual abuse that in the opinion of the investigator may interfere with the patient's assessment of vaginal pain with sexual activity. Past or current diagnosis of endometrial hyperplasia. Patients with known, suspected or current history of carcinoma of the breast. Any patients with past or current undiagnosed vaginal bleeding or significant risk factors for endometrial cancer. History of estrogen-dependent neoplasia (e.g., endometrial cancer). Any patients with hypersensitivity to estrogens. Liver impairment or disease or kidney dysfunction or disorder (e.g., chronic renal failure or hepatitis C). History of thrombophlebitis, thrombosis, or thromboembolic disorders. History of cerebrovascular accident, stroke, or transient ischemic attack. History of Myocardial infarction or ischemic heart disease. History or active presence of endocrine disease (except for controlled hypo- or hyper-thyroidism or controlled non-insulin dependent diabetes mellitus). Patients who are on a stable thyroid medication prior to the study should have normal baseline thyroid function test results and expect not to have to change thyroid hormone regimen during the study. Any clinically significant abnormalities on screening physical exam, assessments, ECG, or laboratory tests such as: Vulvar or vaginal inflammatory condition such as a contact or allergic dermatitis, lichen sclerosis, or other pathological findings. Presence of suspicious vulvar or vaginal lesions for dysplasia, malignancy, or other pathology other than atrophy. History of active or chronic pelvic pain. Painful genital warts or localized areas of ulceration. Interstitial cystitis. Unresolved findings suspicious for malignancy on the breast exam; incomplete mammogram result or unresolved findings suggestive of malignant changes or findings requiring follow-up on the pre-study mammogram. Patients with an intact uterus who have an endometrial thickness of 4mm or greater. Any prescription treatment for vaginal dryness/irritation within 2 weeks before screening or any over the counter or natural remedies, vaginal lubricants or moisturizers within 1 week before screening. Taking inducers of CYP3A4 such as St. John's wort, anticonvulsants, phenylbutazone, rifampin, rifabutin, nevirapine and efavirenz. Taking inhibitors of CYP3A4 such as erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir, nelfinavir and grapefruit juice. Fasting triglyceride levels > 350 mg/dL. 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 patient. Patients who have used vaginal hormonal products (i.e. rings, creams, gels) within the 4 weeks before Screening. Patients who have used transdermal estrogen and/or progestin therapy within the 4 weeks before Screening. Patients who have used oral estrogen, progestin, androgen or selective estrogen receptor modular (SERM) containing drug products within 8 weeks before Screening visit. Intrauterine progestin therapy within 8 weeks before Screening. Use of an intrauterine device within 12 weeks before screening visit. Patients who have used estrogen pellet therapy or progestin implants/ injectable drug therapy within the 6 months before Screening. Patients who have engaged in sexual intercourse or used vaginal douching within 24 hours of the screening visit. Inability to understand the requirements of the study and the relative information or are unable or not willing to comply with the study protocol. Patients who are unable or unwilling to give informed consent. Current history of heavy smoking (more than 15 cigarettes per day) or use of e-cigarettes. Current use of marijuana. Recent history of known alcohol or drug abuse, within one year start of the study. Employees of the Investigator or research center or their immediate family members. Receipt of any drug as part of a research study within 60 days before Screening. Previous participation in this study.

Sites / Locations

  • Site 10112Recruiting
  • Site 10146Recruiting
  • Site 10131
  • Site 10132
  • Site 10103Recruiting
  • Site 10124Recruiting
  • Site 10135Recruiting
  • Site 10125
  • Site 10136Recruiting
  • Site 10130
  • Site 10123Recruiting
  • Site 10139Recruiting
  • Site 10115Recruiting
  • Site 10138Recruiting
  • Site 10107Recruiting
  • Site 10144Recruiting
  • Site 10101Recruiting
  • Site 10106Recruiting
  • Site 10143Recruiting
  • Site 10129
  • Site 10116Recruiting
  • Site 10117
  • Site 10121Recruiting
  • Site 10140Recruiting
  • Site 10119Recruiting
  • Site 10114
  • Site 10113Recruiting
  • Site 10104Recruiting
  • Site 10128Recruiting
  • Site 10109Recruiting
  • Site 10122Recruiting
  • Site 10105Recruiting
  • Site 10111Recruiting
  • Site 10147
  • Site 10126Recruiting
  • Site 10137Recruiting
  • Site 10145Recruiting
  • Site 10127Recruiting
  • Site 10134Recruiting
  • Site 10102Recruiting
  • Site 10110Recruiting
  • Site 10118Recruiting
  • Site 10142Recruiting
  • Site 10120Recruiting
  • Site 10141Recruiting
  • Site 10133
  • Site 10108Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Estradiol vaginal inserts, 4 mcg

IMVEXXY® (estradiol vaginal inserts) 4 mcg

Placebo vaginal inserts

Arm Description

Estradiol vaginal inserts, 4 mcg. Insert vaginally once daily for 14 days.

IMVEXXY® (estradiol vaginal inserts) 4 mcg. Insert vaginally once for 14 days.

Placebo vaginal inserts. Insert vaginally once for 14 days.

Outcomes

Primary Outcome Measures

Responder
% Responders where a "Responder" is defined as a patient with: At least a 25% reduction from baseline in the sum of % basal/parabasal + % intermediate cells on vaginal cytology; and Vaginal pH < 5.0 with a change from baseline vaginal pH of at least 0.5
Change in Most Bothersome Symptom
Mean change from baseline to Day 15 in dyspareunia score (the self-identified most bothersome symptom in women with VVA). On a scale of 0 to 3, where 0 = none, 1=mild, 2=moderate and 3 = severe

Secondary Outcome Measures

Treatment Success in Most bothersome symptom
proportion of patients in each treatment group that are considered a Treatment Success at the end of the treatment period evaluated on Day 15. A "Treatment Success" is defined as a score of 0 or 1 on Day 15 for dyspareunia (the self-identified most bothersome symptom at baseline).On a scale of 0 to 3 where 0 = none, 1=mild, 2=moderate and 3 = severe

Full Information

First Posted
November 7, 2022
Last Updated
August 23, 2023
Sponsor
Teva Pharmaceuticals USA
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1. Study Identification

Unique Protocol Identification Number
NCT05617820
Brief Title
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
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Parallel- Design, Multiple-Site Study to Evaluate the Therapeutic Equivalence of Estradiol Vaginal Inserts 4 mcg (Teva Pharmaceuticals, Inc.) With IMVEXXY® (Estradiol Vaginal Inserts) (TherapeuticsMD, Inc.) in the Treatment of Dyspareunia in Women With Vulvar and Vaginal Atrophy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2022 (Actual)
Primary Completion Date
January 23, 2024 (Anticipated)
Study Completion Date
February 6, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Teva Pharmaceuticals USA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
Randomized, double-blind, placebo-controlled, parallel-designed, multiple-site, bioequivalence study with clinical endpoints.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1026 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Estradiol vaginal inserts, 4 mcg
Arm Type
Experimental
Arm Description
Estradiol vaginal inserts, 4 mcg. Insert vaginally once daily for 14 days.
Arm Title
IMVEXXY® (estradiol vaginal inserts) 4 mcg
Arm Type
Active Comparator
Arm Description
IMVEXXY® (estradiol vaginal inserts) 4 mcg. Insert vaginally once for 14 days.
Arm Title
Placebo vaginal inserts
Arm Type
Placebo Comparator
Arm Description
Placebo vaginal inserts. Insert vaginally once for 14 days.
Intervention Type
Drug
Intervention Name(s)
Estradiol
Intervention Description
Vaginal Insert, 4 mcg tablet
Intervention Type
Drug
Intervention Name(s)
Imvexxy
Intervention Description
Estradiol 4 mcg Vaginal Insert
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Vehicle Vaginal Insert
Primary Outcome Measure Information:
Title
Responder
Description
% Responders where a "Responder" is defined as a patient with: At least a 25% reduction from baseline in the sum of % basal/parabasal + % intermediate cells on vaginal cytology; and Vaginal pH < 5.0 with a change from baseline vaginal pH of at least 0.5
Time Frame
15 days
Title
Change in Most Bothersome Symptom
Description
Mean change from baseline to Day 15 in dyspareunia score (the self-identified most bothersome symptom in women with VVA). On a scale of 0 to 3, where 0 = none, 1=mild, 2=moderate and 3 = severe
Time Frame
15 days
Secondary Outcome Measure Information:
Title
Treatment Success in Most bothersome symptom
Description
proportion of patients in each treatment group that are considered a Treatment Success at the end of the treatment period evaluated on Day 15. A "Treatment Success" is defined as a score of 0 or 1 on Day 15 for dyspareunia (the self-identified most bothersome symptom at baseline).On a scale of 0 to 3 where 0 = none, 1=mild, 2=moderate and 3 = severe
Time Frame
15 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Signed, IRB approved informed consent that meets all criteria of current FDA and local regulations. Females aged 40-75 years inclusive who are postmenopausal, with at least: 12 months of spontaneous amenorrhea (women <55 year of age with history of hysterectomy without bilateral oophorectomy prior to natural menopause must have Serum follicle-stimulating hormone (FSH) level > 40 mIU/mL); or 6 months of spontaneous amenorrhea with FSH levels >40mIU/mL; or At least 6 weeks postsurgical bilateral oophorectomy Have less than or equal to 5% superficial cells on vaginal cytological smear. Vaginal pH > 5.0. Moderate to severe symptom of vaginal pain associated with sexual activity considered the most bothersome vaginal symptom (dyspareunia) of VVA by the patient at screening visit. (i.e., a VVA Symptom Self-Assessment Questionnaire score of 2 or 3) (Appendix B). Women should be sexually active (for example, have sexual activity with vaginal penetration within approximately one month of screening visit). Women should anticipate having sexual activity (with vaginal penetration) during the conduct of the study, and agree to at least one episode of sexual intercourse within study days 10-13. Baseline systolic blood pressure should be no greater than 150 mm Hg and diastolic blood pressure no greater than 90 mm Hg. Normal mammogram completed within 9 months before randomization and a normal clinical breast examination prior to randomization in the study. Patients who have underwent complete Hysterectomy, or in the case of patients with an intact uterus (including patients who underwent a partial hysterectomy) the later must have: A documented papanicolaou (PAP) smear conducted within 12 months before randomization with no findings that the Investigator believes would contraindicate the use of topical vaginal estradiol. Documented vaginal ultrasonography results within 3 months before randomization to confirm an inactive endometrial lining, defined as endometrial thickness <4mm. In the opinion of the Investigator, the patient will comply with the protocol and has a high probability of completing the study. Exclusion Criteria: Premenopasual, perimenopausal, pregnant or lactating patient or planning a pregnancy. Significant history or current evidence of chronic infectious disease, system disorder, organ disorder or other medical condition that in the Investigator's opinion would place the study patient at undue risk by participation or could jeopardize the integrity of the study evaluations. Any clinically significant laboratory finding that, in the Investigator's opinion would contraindicate the use of estradiol or compromise patients' safety. Significant history of cholestatic jaundice, hypertension, coronary heart disease or other serious heart problems, uncontrolled diabetes, hypercholesterolemia, hypercalcemia, hypoparathyroidism, hypertriglyceridemia, systemic lupus erythematosus, renal impairment, residual endometriosis posthysterectomy, asthma, epilepsy, migraine, porphyria, hepatic hemangiomas that in the Investigator's opinion would place the study patient at undue risk by participation or could jeopardize the integrity of the study evaluations. History of Protein C, Protein S, or antithrombin deficiency, or other thrombophilic disorder. Patients with known concurrent vaginal infections including but not limited to: Candida albicans, Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhea or Gardnerella vaginalis. Patients with active vaginal herpes simplex infection or have had an outbreak within 40 days before Screening History of sexual abuse that in the opinion of the investigator may interfere with the patient's assessment of vaginal pain with sexual activity. Past or current diagnosis of endometrial hyperplasia. Patients with known, suspected or current history of carcinoma of the breast. Any patients with past or current undiagnosed vaginal bleeding or significant risk factors for endometrial cancer. History of estrogen-dependent neoplasia (e.g., endometrial cancer). Any patients with hypersensitivity to estrogens. Liver impairment or disease or kidney dysfunction or disorder (e.g., chronic renal failure or hepatitis C). History of thrombophlebitis, thrombosis, or thromboembolic disorders. History of cerebrovascular accident, stroke, or transient ischemic attack. History of Myocardial infarction or ischemic heart disease. History or active presence of endocrine disease (except for controlled hypo- or hyper-thyroidism or controlled non-insulin dependent diabetes mellitus). Patients who are on a stable thyroid medication prior to the study should have normal baseline thyroid function test results and expect not to have to change thyroid hormone regimen during the study. Any clinically significant abnormalities on screening physical exam, assessments, ECG, or laboratory tests such as: Vulvar or vaginal inflammatory condition such as a contact or allergic dermatitis, lichen sclerosis, or other pathological findings. Presence of suspicious vulvar or vaginal lesions for dysplasia, malignancy, or other pathology other than atrophy. History of active or chronic pelvic pain. Painful genital warts or localized areas of ulceration. Interstitial cystitis. Unresolved findings suspicious for malignancy on the breast exam; incomplete mammogram result or unresolved findings suggestive of malignant changes or findings requiring follow-up on the pre-study mammogram. Patients with an intact uterus who have an endometrial thickness of 4mm or greater. Any prescription treatment for vaginal dryness/irritation within 2 weeks before screening or any over the counter or natural remedies, vaginal lubricants or moisturizers within 1 week before screening. Taking inducers of CYP3A4 such as St. John's wort, anticonvulsants, phenylbutazone, rifampin, rifabutin, nevirapine and efavirenz. Taking inhibitors of CYP3A4 such as erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir, nelfinavir and grapefruit juice. Fasting triglyceride levels > 350 mg/dL. 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 patient. Patients who have used vaginal hormonal products (i.e. rings, creams, gels) within the 4 weeks before Screening. Patients who have used transdermal estrogen and/or progestin therapy within the 4 weeks before Screening. Patients who have used oral estrogen, progestin, androgen or selective estrogen receptor modular (SERM) containing drug products within 8 weeks before Screening visit. Intrauterine progestin therapy within 8 weeks before Screening. Use of an intrauterine device within 12 weeks before screening visit. Patients who have used estrogen pellet therapy or progestin implants/ injectable drug therapy within the 6 months before Screening. Patients who have engaged in sexual intercourse or used vaginal douching within 24 hours of the screening visit. Inability to understand the requirements of the study and the relative information or are unable or not willing to comply with the study protocol. Patients who are unable or unwilling to give informed consent. Current history of heavy smoking (more than 15 cigarettes per day) or use of e-cigarettes. Current use of marijuana. Recent history of known alcohol or drug abuse, within one year start of the study. Employees of the Investigator or research center or their immediate family members. Receipt of any drug as part of a research study within 60 days before Screening. Previous participation in this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
US MED Info Medical Info
Phone
1-888-483-8279
Email
USMedInfo@tevapharm.com
First Name & Middle Initial & Last Name or Official Title & Degree
Study Director
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
C Dias
Organizational Affiliation
Teva Pharmaceuticals USA
Official's Role
Study Director
Facility Information:
Facility Name
Site 10112
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35218
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 10146
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 10131
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Individual Site Status
Withdrawn
Facility Name
Site 10132
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Site 10103
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 10124
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 10135
City
San Diego
State/Province
California
ZIP/Postal Code
92111
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 10125
City
San Diego
State/Province
California
ZIP/Postal Code
92119
Country
United States
Individual Site Status
Withdrawn
Facility Name
Site 10136
City
Milford
State/Province
Connecticut
ZIP/Postal Code
06460
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 10130
City
Edgewater
State/Province
Florida
ZIP/Postal Code
32132
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Site 10123
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33351
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 10139
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33461
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 10115
City
Leesburg
State/Province
Florida
ZIP/Postal Code
34748
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 10138
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 10107
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 10144
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 10101
City
Miami Springs
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 10106
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 10143
City
Oldsmar
State/Province
Florida
ZIP/Postal Code
34677
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 10129
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Site 10116
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 10117
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Site 10121
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33351
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 10140
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 10119
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 10114
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Site 10113
City
Norcross
State/Province
Georgia
ZIP/Postal Code
30093
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 10104
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67226
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 10128
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 10109
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70001
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 10122
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70127
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 10105
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
95821
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 10111
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 10147
City
North Las Vegas
State/Province
Nevada
ZIP/Postal Code
89030
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Site 10126
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 10137
City
New Bern
State/Province
North Carolina
ZIP/Postal Code
28562
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 10145
City
New Bern
State/Province
North Carolina
ZIP/Postal Code
28562
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 10127
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 10134
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 10102
City
Upper Saint Clair
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 10110
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29405
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 10118
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 10142
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77701
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 10120
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 10141
City
Houston
State/Province
Texas
ZIP/Postal Code
77022
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 10133
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77497
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Site 10108
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

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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

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