Study to Evaluate the Safety and Bioequivalence of Estradiol Vaginal Inserts, 10 mcg and Vagifem® 10 mcg and Compare to Placebo
NCT ID: NCT01779947
Last Updated: 2014-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
519 participants
INTERVENTIONAL
2012-03-31
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Estradiol Vaginal Insert 10 mcg
Estradiol Vaginal Insert 10 mcg - Test Product
Estradiol Vaginal Tablets 10 mcg
Vagifem Tablets 10 mcg
Vagifem® (Estradiol Vaginal Tablets) 10 mcg - Reference Listed Drug
Estradiol Vaginal Tablets 10 mcg
Placebo
Placebo for the test product Estradiol Vaginal Tablets 10 mcg
placebo
Interventions
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Estradiol Vaginal Tablets 10 mcg
placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Healthy female subject aged 30 to 75 years, inclusive, who was postmenopausal, defined as having had 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels \> 40 mIU/mL, or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy.
* At least 1 subject-assessed moderate to severe symptom of VVA among the following 4 symptoms that was identified by the subject as being most bothersome to her:
* Vaginal dryness
* Vaginal and/or vulvar irritation/itching
* Dysuria
* Vaginal pain associated with sexual activity OR
* The presence of vaginal bleeding associated with sexual activity
* Had ≤ 5% superficial cells on vaginal smear cytology at Visit 1.
* Vaginal pH \> 5.0 at Visit 1.
* Systolic blood pressure ≤ 150 mm Hg and diastolic blood pressure ≤ 90 mm Hg at Visit 1.
* If \> 40 years old, documentation of a negative mammogram (obtained at Visit 1 or within 9 months prior to Visit 1). A radiology report documenting a negative mammogram must have been available and must have been taken within 9 months of Visit 1 or obtained at Visit 1.
* Normal clinical breast examination at Visit 1.
* For women with intact uterus, vaginal ultrasonography confirmation at Visit 1 of an inactive endometrial lining, with an endometrial thickness \< 4 mm.
* Documented Pap smear conducted within the previous 12 months of Visit 1 with no findings that the investigator believed would contraindicate the use of topical vaginal estradiol.
* In general good health with no clinically significant disease other than symptoms of VVA that might have interfered with the study evaluations.
* Was willing and able to understand and comply with the requirements of the study, including applying the medication as instructed, returning for the required study visits, complying with therapy prohibitions, and able to complete the study.
Exclusion Criteria
* A subject who had received any treatment listed below more recently than the indicated washout period prior to Visit 1/Screening/Baseline.
* Prohibited Medications - (Washout Period Prior to Visit 1/Screening/Baseline)
* Vaginal lubricants or moisturizers - (at least 48 hours (2 days))
* Vaginal hormonal products (rings, creams, gels) - (at least 1 week (7 days))
* Transdermal estrogen alone or estrogen/progestin products - (at least 4 weeks (28 days))
* Oral estrogen and/or progestin therapy - (at least 8 weeks (56 days))
* Intrauterine progestin therapy - (at least 8 weeks (56 days))
* Progestin implants and estrogen alone injectable drug therapy - (at least 3 months (90 days))
* Estrogen pellet therapy or progestin injectable drug therapy - (at least 6 months (180 days))
* Subject who had engaged in sexual intercourse within 48 hours (2 days) of Visit 1.
* Screening mammogram or clinical breast examination results indicating any suspicion of breast malignancy.
* History of undiagnosed vaginal bleeding.
* Known bleeding disorder.
* History of significant risk factors for endometrial cancer (i.e., tamoxifen use, prior pelvic radiation therapy, and endometrial hyperplasia).
* For women with an intact uterus, screening vaginal ultrasonography showing endometrial thickness of ≥ 4 mm.
* Known, suspected, or history of breast cancer or cervical cancer.
* Known or suspected estrogen-dependent neoplasia.
* History of uncontrolled hypertension.
* Active deep vein thrombosis, pulmonary embolism, or history of these conditions.
* Active arterial thromboembolic disease (e.g., stroke or myocardial infarction) or a history of these conditions.
* Known liver dysfunction or disease.
* Known anaphylactic reaction or angioedema to estradiol vaginal tablets.
* Known protein C, protein S, antithrombin deficient, or other known thrombophilic disorders. - Active vaginal herpes simplex infection or any known concurrent vaginal infections.
* Abnormal Pap smear within the previous 12 months of Visit 1 or obtained during Visit 1. Any evidence of malignancy or premalignant changes or atypical squamous cell of undetermined significance (ASCUS) Pap smear with positive high risk human papillomavirus (HPV).
* Any clinically significant condition or situation (including laboratory values) other than the condition being studied that, in the opinion of the investigator, would have interfered with the study evaluations or optimal participation in the study.
* Use of any investigational drugs or device within 30 days of signing the ICF.
* Current participation in any other clinical study involving an investigational drug or device.
* Consumed excessive amounts of alcohol, abused drugs, or had any condition that would have compromised compliance with this protocol.
* Previous participation in this study.
* Subjects who, in the opinion of the Investigator, would have been non-compliant with the requirements of the study protocol.
30 Years
75 Years
FEMALE
No
Sponsors
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Amneal Pharmaceuticals, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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W. Todd Kays, PhD
Role: STUDY_CHAIR
Amneal Pharmaceuticals, LLC
Locations
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Medical Affiliated Research center, Inc.
Huntsville, Alabama, United States
Montogmery Women's Health Associates
Montgomery, Alabama, United States
Medical Center for Clinical Research
San Diego, California, United States
Women's Health Care Research Corp.
San Diego, California, United States
Downtown Women's Health care
Denver, Colorado, United States
Horizons Clinical Research Center
Denver, Colorado, United States
James A. Simon, MD PC/ Women's Health and Research Consultants
Washington D.C., District of Columbia, United States
Visions Clinical Reserach
Boynton Beach, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Altus Research
Lake Worth, Florida, United States
New Age Medical Reserach Group
Miami, Florida, United States
Comprehensive Clinical Trials, LLC
West Palm Beach, Florida, United States
Atlanta North Gynecology
Roswell, Georgia, United States
Mount Vernon Clinical Research, LLC
Sandy Springs, Georgia, United States
Cypress Medical Research Center. LLC
Wichita, Kansas, United States
Meridian Health Care
Neptune City, New Jersey, United States
Center for Women's Health and Wellness, LLC/ Women's Health Research Center
Plainsboro, New Jersey, United States
Premier Medical Group of the Hudson Valley
Poughkeepsie, New York, United States
Lyndhurst Clinical Research
Raleigh, North Carolina, United States
Wake Research Associates
Raleigh, North Carolina, United States
Hawthorne Medical Research, Inc.
Winstom-Salem, North Carolina, United States
Lyndhurst Clinical Research
Winston-Salem, North Carolina, United States
Columbus Center for Women;s Health Reserach
Columbus, Ohio, United States
Clinical Research of Philadelphia, LLC
Philadelphia, Pennsylvania, United States
Seatlle Womne's Health,Reserach, Gynecology
Seattle, Washington, United States
Countries
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Other Identifiers
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AM-ESD-001
Identifier Type: -
Identifier Source: org_study_id
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