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

Completed · Phase 3 · Has a placebo group

Conditions studied: Atrophic Vaginitis

In brief

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.

Key facts

Study ID

NCT02195986

Run by

Mylan Pharmaceuticals Inc

People needed

366

Starts

2014-06-01

Expected to finish

2014-12-01

Last updated by the study team

2022-03-09

Who can join

Age: 40 and older, up to 70. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• ARA-Arizona Research Associates — Tucson, Arizona, United States
• Axis Clinical Trials — Los Angeles, California, United States
• Northern CA Research — Sacramento, California, United States
• MCCR — San Diego, California, United States
• Women's Health Care Research Corp. — San Diego, California, United States
• MCB Clinical Research Centers — Colorado Springs, Colorado, United States
• Downtown Women's Health Care — Denver, Colorado, United States
• Horizons Clinical Research Center, LLC — Denver, Colorado, United States
• Sunrise Medical Research — Coral Springs, Florida, United States
• Health Awareness, Inc. — Jupiter, Florida, United States
• Meridien Research — Lakeland, Florida, United States
• OB-GYN Associates of Mid Florida — Leesburg, Florida, United States
• SouthCoast Research Center — Miami, Florida, United States
• Veritas Research, Corp. — Miami Lakes, Florida, United States
• Physician Care Clinical Research LLC — Sarasota, Florida, United States
• Meridien Research — St. Petersburg, Florida, United States
• Sunrise Medical Research — Tamarac, Florida, United States
• Comprehensive Clinical Trials, LLC — West Palm Beach, Florida, United States
• Georgia Center for Women — Atlanta, Georgia, United States
• Lawrence OB/GYN Clinical Research, LLC — Lawrenceville, New Jersey, United States
• Women's Health Research Center/The Center for Women's Health & Wellness, LLC — Plainsboro, New Jersey, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.