Study to Evaluate the Safety and Bioequivalence of Estradiol Vaginal Inserts, 10 mcg and Vagifem® 10 mcg and Compare to Placebo

Completed · Phase 3 · Has a placebo group

Conditions studied: Atrophic Vaginitis Due to Menopause

In brief

The purpose of this study is to compare the safety and efficacy of generic Estradiol Vaginal Inserts, USP 10 mcg to the reference product Vagifem® 10 mcg and to determined whether the efficacy of each of the 2 active treatments is superior to that of the placebo.

Key facts

Study ID

NCT01779947

Run by

Amneal Pharmaceuticals, LLC

People needed

519

Starts

2012-03-01

Expected to finish

2012-12-01

Last updated by the study team

2014-06-26

Who can join

Age: 30 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Willing and able to provide and understand written informed consent for the study.
• 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.

You may not qualify if…

• Known hypersensitivity to estradiol vaginal tablet or any component of the study medication.
• 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).

Where it is running

• 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

Full record on ClinicalTrials.gov

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