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

Primary Purpose

Atrophic Vaginitis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Estradiol Vaginal Cream, 0.01%
Estrace® 0.01% cream
Placebo Vaginal Cream
Sponsored by
Mylan Pharmaceuticals Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrophic Vaginitis focused on measuring vaginal dryness, vaginal and/or vulvar irritation/itching, dysuria, vaginal pain and bleeding associated with sexual activity, vaginal atrophy

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Capable of providing informed consent.
  2. Age: 40-70 years old.
  3. Sex: Female
  4. Postmenopausal defined as at least 12 months of spontaneous amenorrhea or at least 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/ml or at least 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy.
  5. Weight: At least 48 kg with all subjects having a Body Mass Index less than or equal to 38 kg/m2 but greater than or equal to 19 kg/m2.
  6. Baseline evaluation requirements:

    • ≤5% superficial cells on vaginal smear cytology
    • Vaginal pH > 5.0
    • At least one patient self-assessed moderate to severe symptom of vulvar and/or vaginal atrophy (VVA) from the following list that is identified by the subject:
    • Vaginal dryness
    • Vaginal and/or vulvar irritation/itching
    • Dysuria
    • Vaginal pain associated with sexual activity
    • Vaginal bleeding associated with sexual activity (absence vs. presence)
  7. All subjects should be judged to be eligible for participation in this study by the principal or sub-investigator physician during a pre-study medical evaluation performed within 28 days of the initial dose of study medication which will include:

    1. a normal or non-clinically significant physical examination, including vital signs
    2. a normal or non-clinically significant pelvic examination that was consistent with hypoestrogenemia
    3. a normal or non-clinically significant breast exam and mammogram
    4. a normal or non-clinically significant ASCUS Papanicolaou ("Pap") smear that is negative for HPV for subjects with an intact uterus and cervix
    5. within normal limits or non-clinically significant laboratory evaluation results (unless otherwise noted in the exclusion criteria) for the following tests:

      • Serum Chemistry
      • Hematology
      • Coagulogram
      • Urinalysis
    6. normal or non-clinically significant 12- Lead ECG.
    7. negative urine drug screen including amphetamine, barbiturates, benzodiazepines, cannabinoid, cocaine, opiates, methadone and phencyclidine with the following exceptions: positive tests for amphetamines, barbiturates, benzodiazepines, or opiates may be allowed provided the subject has a valid prescription and is on a stable regimen that complies with Exclusion Criteria, Section 6.3.2.
    8. negative urine cotinine test.
  8. For women with an intact uterus, an endometrial thickness < 5 mm as determined by vaginal ultrasonography.
  9. If warranted, other tests or examinations may be performed at the discretion of the Principal Investigator or responsible physician.
  10. Ability to use applicator properly.

Exclusion Criteria:

  1. Institutionalized subjects will not be used.
  2. Any contraindication to estrogen therapy.
  3. Social Habits:

    1. Use of any tobacco-containing products within 1 year of the start of the study.
    2. Regular intake of more than 7 units of alcohol per week.
    3. Beginning any new regimens of vitamins or herbal products within 7 days prior to the initial dose of the study medication.
    4. Any recent, significant change in dietary or exercise habits.
    5. History of drug and/or alcohol abuse within one year of start of study.
  4. Medications:

    1. Use of any new prescription or over-the-counter (OTC) medication regimens within fourteen (14) days prior to the initial dose of study medication (any necessary medication, unless otherwise noted in the exclusion criteria, for which dosing has been stabilized for a period of at least 14 days prior to initial dosing of study drug and is expected to remain stable for the entire study period is allowed, with the exception of acetaminophen, which may be administered as needed to treat minor adverse events).
    2. Use of hormonal replacement therapies for the following time periods:

      • within 2 weeks of baseline assessment for vaginal therapy (rings, creams, gels)
      • within 4 weeks of baseline assessment for transdermal estrogen alone or estrogen/progestin therapy
      • within 8 weeks of baseline assessment for oral estrogen and/or progestin therapy or intrauterine progestin therapy
      • within 3 months of baseline assessments for progestin implants or estrogen alone injectable therapy
      • within 6 months of baseline assessments for estrogen pellet or progestin injectable therapy
    3. A depot injection or implant of any drug within 3 months prior to administration of study medication.
    4. Currently taking medication indicated for anticoagulation as a result of an excluded condition listed in #5 below. This includes but is not limited to warfarin, heparin, NSAIDs, clopidogrel, dabigatran, etc.
  5. Diseases:

    1. History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychological, urinary, musculoskeletal disease or malignancies unless under medical control and/or deemed not clinically significant by the Principal Investigator or Medical Sub-investigator.
    2. Manifestation or treatment for significant cardiovascular disease (congestive heart failure, stroke or ischemic attack, myocardial infarction, coronary artery bypass, percutaneous angioplasty or > 50% angiographic narrowing of coronary artery, thrombosis of deep veins and arteries, thromboembolic disorders, pulmonary embolism) or history of these conditions.
    3. Coronary artery or cerebrovascular disease.
    4. Current clinically significant liver or kidney dysfunction/disorders.
    5. Current clinically significant gallbladder dysfunction/disorders.
    6. Abnormal or clinically significant breast examination. Acceptable breast examination is defined as no masses or other findings identified that are suspicious of malignancy.
    7. First degree family history of breast cancer.
    8. Current non diet controlled diabetes mellitus or other clinically significant endocrinological disease.
    9. Estrogen-dependent neoplasia
    10. Postmenopausal uterine bleeding
    11. Endometrial hyperplasia
    12. Uncontrolled hypothyroidism
    13. Urinalysis showing an ongoing clinically significant urinary tract infection that requires treatment.
    14. Current clinically significant vaginal infection that requires treatment.
    15. Known chronic lichen sclerosis
    16. Acute illness at the time of either the pre-study medical evaluation or dosing.
    17. History of allergy or hypersensitivity to estradiol, other related products, or any inactive ingredients.
    18. Undiagnosed vaginal bleeding or history of significant risk factors for endometrial cancer.
    19. Increased frequency or severity of headaches while on previous hormone or estrogen therapy.
    20. History of psychiatric disorders occurring within the last 6 months that require hospitalization or medication.
    21. Current hypercalcemia, hypocalcemia, and/or hypertriglyceridemia.
    22. Clinically significant eye/visual abnormalities such as retinal vascular thrombosis, partial or complete loss of vision, proptosis, diplopia, papilledema, retinal vascular lesions.
  6. Any reason which, in the opinion of the Principal Investigator or Medical Sub-Investigator, would prevent the subject from safely participating in the study.
  7. Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication.
  8. Sitting blood pressure higher than 150/90 mmHg at screening.
  9. Baseline serum estradiol levels >30 pg/mL at screening.

Sites / Locations

  • ARA-Arizona Research Associates
  • Axis Clinical Trials
  • Northern CA Research
  • MCCR
  • Women's Health Care Research Corp.
  • MCB Clinical Research Centers
  • Downtown Women's Health Care
  • Horizons Clinical Research Center, LLC
  • Sunrise Medical Research
  • Health Awareness, Inc.
  • Meridien Research
  • OB-GYN Associates of Mid Florida
  • Veritas Research, Corp.
  • SouthCoast Research Center
  • Meridien Research
  • Physician Care Clinical Research LLC
  • Sunrise Medical Research
  • Comprehensive Clinical Trials, LLC
  • Georgia Center for Women
  • Lawrence OB/GYN Clinical Research, LLC
  • Women's Health Research Center/The Center for Women's Health & Wellness, LLC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Estradiol Vaginal Cream

Estrace® 0.01% cream

Placebo Vaginal Cream

Arm Description

Estradiol Vaginal Cream, 0.01%, administered once daily for 7 days.

Estrace® 0.01% vaginal cream, administered once daily for 7 days.

Placebo Vaginal Cream, administered once daily for 7 days.

Outcomes

Primary Outcome Measures

Primary Endpoint (Vaginal Cytology + Vaginal pH) Equivalence
Treatment comparison of the proportion of patients in the Per Protocol (PP) population who received either Estradiol Vaginal Cream or Estrace® that were identified as responders at the end of the treatment period on Study Day 8. A responder was 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.
Primary Endpoint (Vaginal Cytology + Vaginal pH) Comparison of Active Treatments to Placebo
Treatment comparison of the proportion of patients in the Per Protocol (PP) population who received either Estradiol Vaginal Cream, Estrace®, or Placebo that were identified as responders at the end of the treatment period on Study Day 8. A responder was 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.

Secondary Outcome Measures

Comparison of the Number of Participants With Treatment Success for the Patient Self-assessment of the Symptoms of Vulvar and Vaginal Atrophy - Equivalence
Evaluation and comparison between Estradiol Vaginal Cream and Estrace® treatment groups of the change from baseline in the most bothersome vulvar and/or vaginal atrophy symptom including vaginal dryness, vaginal and/or vulvar irritation/itching, dysuria, vaginal pain associated with sexual activity, or vaginal bleeding associated with sexual activity as identified by each subject. A score ≤ 1 on Study Day 8 for the most bothersome symptom as identified by the subject at baseline (Study Day -1) was considered a treatment success. A score ≥ 2 on Study Day 8 for the most bothersome symptom as identified by the subject at baseline (Study Day -1) was considered a treatment failure.
Comparison of the Number of Participants With Treatment Success for the Patient Self-assessment of the Symptoms of Vulvar and Vaginal Atrophy - Comparison to Placebo
Evaluation and comparison between Estradiol Vaginal Cream, Estrace®, and Placebo treatment groups of the change from baseline in the most bothersome vulvar and/or vaginal atrophy symptom including vaginal dryness, vaginal and/or vulvar irritation/itching, dysuria, vaginal pain associated with sexual activity, or vaginal bleeding associated with sexual activity as identified by each subject. A score ≤ 1 on Study Day 8 for the most bothersome symptom as identified by the subject at baseline (Study Day -1) was considered a treatment success. A score ≥ 2 on Study Day 8 for the most bothersome symptom as identified by the subject at baseline (Study Day -1) was considered a treatment failure.

Full Information

First Posted
July 16, 2014
Last Updated
March 7, 2022
Sponsor
Mylan Pharmaceuticals Inc
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1. Study Identification

Unique Protocol Identification Number
NCT02195986
Brief Title
A Comparison of Estradiol Vaginal Cream to Estrace® Cream in 350 Postmenopausal Females With Atrophic Vaginitis
Official Title
Clinical Endpoint Therapeutic Equivalence Multi-Site Study Comparing Estradiol Vaginal Cream (0.01%; Mylan) to Estrace® Cream (0.01%; Warner Chilcott) in Postmenopausal Females With Atrophic Vaginitis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mylan Pharmaceuticals Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine the therapeutic equivalence of Mylan's estradiol vaginal cream to Estrace® cream and superiority of both products to placebo. The protocol describes a randomized, double-blind, multi-dose, placebo-controlled, parallel study of a 7 day treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrophic Vaginitis
Keywords
vaginal dryness, vaginal and/or vulvar irritation/itching, dysuria, vaginal pain and bleeding associated with sexual activity, vaginal atrophy

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Estradiol Vaginal Cream
Arm Type
Experimental
Arm Description
Estradiol Vaginal Cream, 0.01%, administered once daily for 7 days.
Arm Title
Estrace® 0.01% cream
Arm Type
Active Comparator
Arm Description
Estrace® 0.01% vaginal cream, administered once daily for 7 days.
Arm Title
Placebo Vaginal Cream
Arm Type
Placebo Comparator
Arm Description
Placebo Vaginal Cream, administered once daily for 7 days.
Intervention Type
Drug
Intervention Name(s)
Estradiol Vaginal Cream, 0.01%
Intervention Description
Estradiol Vaginal Cream, 0.01% (1 x 2g for 7 days)
Intervention Type
Drug
Intervention Name(s)
Estrace® 0.01% cream
Intervention Description
Estrace® 0.01% vaginal cream ( 1 x 2g for 7 days)
Intervention Type
Drug
Intervention Name(s)
Placebo Vaginal Cream
Intervention Description
Placebo Vaginal Cream ( 1 x 2 g for 7 days)
Primary Outcome Measure Information:
Title
Primary Endpoint (Vaginal Cytology + Vaginal pH) Equivalence
Description
Treatment comparison of the proportion of patients in the Per Protocol (PP) population who received either Estradiol Vaginal Cream or Estrace® that were identified as responders at the end of the treatment period on Study Day 8. A responder was 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
Study Day 8
Title
Primary Endpoint (Vaginal Cytology + Vaginal pH) Comparison of Active Treatments to Placebo
Description
Treatment comparison of the proportion of patients in the Per Protocol (PP) population who received either Estradiol Vaginal Cream, Estrace®, or Placebo that were identified as responders at the end of the treatment period on Study Day 8. A responder was 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
Study Day 8
Secondary Outcome Measure Information:
Title
Comparison of the Number of Participants With Treatment Success for the Patient Self-assessment of the Symptoms of Vulvar and Vaginal Atrophy - Equivalence
Description
Evaluation and comparison between Estradiol Vaginal Cream and Estrace® treatment groups of the change from baseline in the most bothersome vulvar and/or vaginal atrophy symptom including vaginal dryness, vaginal and/or vulvar irritation/itching, dysuria, vaginal pain associated with sexual activity, or vaginal bleeding associated with sexual activity as identified by each subject. A score ≤ 1 on Study Day 8 for the most bothersome symptom as identified by the subject at baseline (Study Day -1) was considered a treatment success. A score ≥ 2 on Study Day 8 for the most bothersome symptom as identified by the subject at baseline (Study Day -1) was considered a treatment failure.
Time Frame
Day 8
Title
Comparison of the Number of Participants With Treatment Success for the Patient Self-assessment of the Symptoms of Vulvar and Vaginal Atrophy - Comparison to Placebo
Description
Evaluation and comparison between Estradiol Vaginal Cream, Estrace®, and Placebo treatment groups of the change from baseline in the most bothersome vulvar and/or vaginal atrophy symptom including vaginal dryness, vaginal and/or vulvar irritation/itching, dysuria, vaginal pain associated with sexual activity, or vaginal bleeding associated with sexual activity as identified by each subject. A score ≤ 1 on Study Day 8 for the most bothersome symptom as identified by the subject at baseline (Study Day -1) was considered a treatment success. A score ≥ 2 on Study Day 8 for the most bothersome symptom as identified by the subject at baseline (Study Day -1) was considered a treatment failure.
Time Frame
Day 8

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Capable of providing informed consent. Age: 40-70 years old. Sex: Female Postmenopausal defined as at least 12 months of spontaneous amenorrhea or at least 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/ml or at least 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy. Weight: At least 48 kg with all subjects having a Body Mass Index less than or equal to 38 kg/m2 but greater than or equal to 19 kg/m2. Baseline evaluation requirements: ≤5% superficial cells on vaginal smear cytology Vaginal pH > 5.0 At least one patient self-assessed moderate to severe symptom of vulvar and/or vaginal atrophy (VVA) from the following list that is identified by the subject: Vaginal dryness Vaginal and/or vulvar irritation/itching Dysuria Vaginal pain associated with sexual activity Vaginal bleeding associated with sexual activity (absence vs. presence) All subjects should be judged to be eligible for participation in this study by the principal or sub-investigator physician during a pre-study medical evaluation performed within 28 days of the initial dose of study medication which will include: a normal or non-clinically significant physical examination, including vital signs a normal or non-clinically significant pelvic examination that was consistent with hypoestrogenemia a normal or non-clinically significant breast exam and mammogram a normal or non-clinically significant ASCUS Papanicolaou ("Pap") smear that is negative for HPV for subjects with an intact uterus and cervix within normal limits or non-clinically significant laboratory evaluation results (unless otherwise noted in the exclusion criteria) for the following tests: Serum Chemistry Hematology Coagulogram Urinalysis normal or non-clinically significant 12- Lead ECG. negative urine drug screen including amphetamine, barbiturates, benzodiazepines, cannabinoid, cocaine, opiates, methadone and phencyclidine with the following exceptions: positive tests for amphetamines, barbiturates, benzodiazepines, or opiates may be allowed provided the subject has a valid prescription and is on a stable regimen that complies with Exclusion Criteria, Section 6.3.2. negative urine cotinine test. For women with an intact uterus, an endometrial thickness < 5 mm as determined by vaginal ultrasonography. If warranted, other tests or examinations may be performed at the discretion of the Principal Investigator or responsible physician. Ability to use applicator properly. Exclusion Criteria: Institutionalized subjects will not be used. Any contraindication to estrogen therapy. Social Habits: Use of any tobacco-containing products within 1 year of the start of the study. Regular intake of more than 7 units of alcohol per week. Beginning any new regimens of vitamins or herbal products within 7 days prior to the initial dose of the study medication. Any recent, significant change in dietary or exercise habits. History of drug and/or alcohol abuse within one year of start of study. Medications: Use of any new prescription or over-the-counter (OTC) medication regimens within fourteen (14) days prior to the initial dose of study medication (any necessary medication, unless otherwise noted in the exclusion criteria, for which dosing has been stabilized for a period of at least 14 days prior to initial dosing of study drug and is expected to remain stable for the entire study period is allowed, with the exception of acetaminophen, which may be administered as needed to treat minor adverse events). Use of hormonal replacement therapies for the following time periods: within 2 weeks of baseline assessment for vaginal therapy (rings, creams, gels) within 4 weeks of baseline assessment for transdermal estrogen alone or estrogen/progestin therapy within 8 weeks of baseline assessment for oral estrogen and/or progestin therapy or intrauterine progestin therapy within 3 months of baseline assessments for progestin implants or estrogen alone injectable therapy within 6 months of baseline assessments for estrogen pellet or progestin injectable therapy A depot injection or implant of any drug within 3 months prior to administration of study medication. Currently taking medication indicated for anticoagulation as a result of an excluded condition listed in #5 below. This includes but is not limited to warfarin, heparin, NSAIDs, clopidogrel, dabigatran, etc. Diseases: History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychological, urinary, musculoskeletal disease or malignancies unless under medical control and/or deemed not clinically significant by the Principal Investigator or Medical Sub-investigator. Manifestation or treatment for significant cardiovascular disease (congestive heart failure, stroke or ischemic attack, myocardial infarction, coronary artery bypass, percutaneous angioplasty or > 50% angiographic narrowing of coronary artery, thrombosis of deep veins and arteries, thromboembolic disorders, pulmonary embolism) or history of these conditions. Coronary artery or cerebrovascular disease. Current clinically significant liver or kidney dysfunction/disorders. Current clinically significant gallbladder dysfunction/disorders. Abnormal or clinically significant breast examination. Acceptable breast examination is defined as no masses or other findings identified that are suspicious of malignancy. First degree family history of breast cancer. Current non diet controlled diabetes mellitus or other clinically significant endocrinological disease. Estrogen-dependent neoplasia Postmenopausal uterine bleeding Endometrial hyperplasia Uncontrolled hypothyroidism Urinalysis showing an ongoing clinically significant urinary tract infection that requires treatment. Current clinically significant vaginal infection that requires treatment. Known chronic lichen sclerosis Acute illness at the time of either the pre-study medical evaluation or dosing. History of allergy or hypersensitivity to estradiol, other related products, or any inactive ingredients. Undiagnosed vaginal bleeding or history of significant risk factors for endometrial cancer. Increased frequency or severity of headaches while on previous hormone or estrogen therapy. History of psychiatric disorders occurring within the last 6 months that require hospitalization or medication. Current hypercalcemia, hypocalcemia, and/or hypertriglyceridemia. Clinically significant eye/visual abnormalities such as retinal vascular thrombosis, partial or complete loss of vision, proptosis, diplopia, papilledema, retinal vascular lesions. Any reason which, in the opinion of the Principal Investigator or Medical Sub-Investigator, would prevent the subject from safely participating in the study. Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication. Sitting blood pressure higher than 150/90 mmHg at screening. Baseline serum estradiol levels >30 pg/mL at screening.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matt Hummel, Ph.D.
Organizational Affiliation
Mylan Pharmaceuticals Inc
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ronald Ackerman, M.D.
Organizational Affiliation
Comprehensive Clinical Trials, LLC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James Andersen, M.D.
Organizational Affiliation
Meridien Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Keith Aqua, M.D.
Organizational Affiliation
Visions Clinical Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Theodore Cooper, M.D.
Organizational Affiliation
Horizons Clinical Research Center, LLC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Scott Eder, M.D.
Organizational Affiliation
Women's Health Research Center/The Center for Women's Health & Wellness, LLC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William Koltun, M.D.
Organizational Affiliation
Medical Center for Clinical Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gigi Lefebvre, M.D.
Organizational Affiliation
Meridien Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Leonard Ranasinghe, M.D.
Organizational Affiliation
Northern CA Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rovena Reagan, M.D.
Organizational Affiliation
Women's Health Care Research Corp.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ronald Surowitz, D.O.
Organizational Affiliation
Health Awareness, Inc.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Steven Sussman, M.D.
Organizational Affiliation
Lawrence OB/GYN Clinical Research, LLC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
G. Michael Swor, M.D.
Organizational Affiliation
Physician Care Clinical Research LLC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Olga Tudela, M.D.
Organizational Affiliation
Veritas Research., Corp.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Arthur Waldbaum, M.D.
Organizational Affiliation
Downtown Women's Health Care
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maria C Fernandez, M.D.
Organizational Affiliation
South Coast Research Center, Inc.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gary Carson, M.D
Organizational Affiliation
Northern CA Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lydie Hazan, M.D.
Organizational Affiliation
Axis Clinical Trials
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alfred Moffett, M.D.
Organizational Affiliation
OB-GYN Associates of Mid Florida
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tracey Lemon, M.D.
Organizational Affiliation
Georgia Center for Women
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Steven Foley, M.D.
Organizational Affiliation
MCB Clinical Research Centers, LLC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jason Haffizulla, M.D.
Organizational Affiliation
Sunrise Medical Research, Inc.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert Hunter, M.D.
Organizational Affiliation
ARA-Arizona Research Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
ARA-Arizona Research Associates
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Axis Clinical Trials
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Northern CA Research
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Facility Name
MCCR
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Women's Health Care Research Corp.
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
MCB Clinical Research Centers
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80910
Country
United States
Facility Name
Downtown Women's Health Care
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
Horizons Clinical Research Center, LLC
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Sunrise Medical Research
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33065
Country
United States
Facility Name
Health Awareness, Inc.
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Meridien Research
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
OB-GYN Associates of Mid Florida
City
Leesburg
State/Province
Florida
ZIP/Postal Code
34748
Country
United States
Facility Name
Veritas Research, Corp.
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
SouthCoast Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Meridien Research
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
Physician Care Clinical Research LLC
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Sunrise Medical Research
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33351
Country
United States
Facility Name
Comprehensive Clinical Trials, LLC
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Georgia Center for Women
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30312
Country
United States
Facility Name
Lawrence OB/GYN Clinical Research, LLC
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08690
Country
United States
Facility Name
Women's Health Research Center/The Center for Women's Health & Wellness, LLC
City
Plainsboro
State/Province
New Jersey
ZIP/Postal Code
08536
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
N/A - Phase I study

Learn more about this trial

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

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