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Estradiol Vaginal Softgel Capsules in Treating Symptoms of Vulvar and Vaginal Atrophy in Postmenopausal Women

Information source: TherapeuticsMD
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Vulvovaginal Atrophy; Menopause; Dyspareunia; Painful Intercourse

Intervention: Estradiol (Drug); Placebo (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: TherapeuticsMD

Summary

This study will assess the safety and efficacy of a new formulation of vaginal estradiol for the treatment of symptoms of vulvar and vaginal atrophy in postmenopausal women.

Clinical Details

Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Multi-center Trial to Evaluate the Safety and Efficacy of TX-004HR in Postmenopausal Women With Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Co-Primary Efficacy Endpoint - Vaginal Superficial Cells

Co-Primary Efficacy Endpoint - Vaginal Parabasal Cells

Co-Primary Efficacy Endpoint - Vaginal pH

Co-Primary Efficacy Endpoint - Severity of Most Bothersome Symptom (Dyspareunia)

Secondary outcome:

Secondary Efficacy Endpoints - Vaginal Superficial and Parabasal Cells, Vaginal pH and Severity of MBS (dyspareunia)

Secondary Efficacy Endpoints - Severity of other VVA symptoms and visual evaluation of vaginal mucosa

Secondary Efficacy Endpoints - Female Sexual Function Index (FSFI)

Secondary Efficacy Endpoints - Hormone Concentration Assessments (serum estradiol, estrone and estrone conjugates; SHBG) - PK Substudy

Eligibility

Minimum age: 40 Years. Maximum age: 75 Years. Gender(s): Female.

Criteria:

Inclusion Criteria: 1. Postmenopausal female subjects between the ages of 40 and 75 years (at the time of randomization) with at least:

- 12 months of spontaneous amenorrhea (women <55 years of age with a history of

hysterectomy without bilateral oophorectomy prior to natural menopause must have follicle stimulating hormone (FSH) levels > 40 mIU/mL), OR

- 6 months of spontaneous amenorrhea with follicle stimulating hormone (FSH)

levels > 40mlU/mL OR

- At least 6 weeks postsurgical bilateral oophorectomy.

2. ≤5% superficial cells on vaginal cytological smear 3. Vaginal pH > 5. 0 4. Moderate to severe symptom of vaginal pain associated with sexual activity considered the most bothersome vaginal symptom by the subject at screening visit 1A. 5. Moderate to severe symptom of vaginal pain associated with sexual activity at screening visit 1B. 6. Onset of moderate to severe dyspareunia in the postmenopausal years. 7. Subjects should be sexually active (i. e. have sexual activity with vaginal penetration within approximately 1 month of screening visit 1A). 8. Subjects should anticipate having sexual activity (with vaginal penetration) during the conduct of the trial. 9. For subjects with an intact uterus: Subjects must have an acceptable result from an evaluable screening endometrial biopsy. 10. Subjects who have a Body Mass Index (BMI) less than or equal to 38 kg/m2. BMI values should be rounded to the nearest integer (ex. 32. 4 rounds down to 32, while 26. 5 rounds up to 27). 11. In the opinion of the investigator, the subject will comply with the protocol and has a high probability of completing the study. Exclusion Criteria: 1. Use of the following: 1. Oral estrogen-, progestin-, androgen-, or SERM-containing drug products within 8 weeks before screening visit 1A (can enter washout); 2. Use of transdermal hormone products within 4 weeks before screening visit 1A (can enter washout); 3. Use of vaginal hormone products (rings, creams, gels) within 4 weeks before screening visit1A (can enter washout); 4. Use of intrauterine progestins within 8 weeks before screening visit 1A (can enter washout); 5. Use of progestin implants/injectables or estrogen pellets/injectables within 6 months before screening visit 1A (cannot enter washout); 6. Use of vaginal lubricants or moisturizers within 7 days before the screening visit 1B vaginal pH assessment. 2. A history or active presence of clinically important medical disease that might confound the study or be detrimental to the subject, examples include: 1. Hypersensitivity to estrogens; 2. Endometrial hyperplasia; 3. Undiagnosed vaginal bleeding; 4. Have a history of a chronic liver or kidney dysfunction/disorder (e. g., Hepatitis C or chronic renal failure); 5. Thrombophlebitis, thrombosis or thromboembolic disorders; 6. Cerebrovascular accident, stroke, or transient ischemic attack; 7. Myocardial infarction or ischemic heart disease; 8. Malignancy or treatment for malignancy, within the previous 5 years, with the exception of basal cell carcinoma of the skin or squamous cell carcinoma of the skin. A history of estrogen dependent neoplasia, breast cancer, melanoma or any gynecologic cancer, at any time, excludes the subject; 9. Endocrine disease (except for controlled hypothyroidism or controlled non-insulin dependent diabetes mellitus). 3. Recent history of known alcohol or drug abuse. 4. History of sexual abuse or spousal abuse that, in the opinion of the PI, may interfere with the subject's assessment of vaginal pain with sexual activity. 5. Current history of Heavy smoking (more than 15 cigarettes per day) or use of e-cigarettes. 6. Use of an intrauterine device within 12 weeks before screening visit 1A. 7. Use of an investigational drug within 60 days before screening visit 1A. 8. Any clinically important abnormalities on screening physical exam, assessments, ECG, or laboratory tests, such as: 1. Unresolved cervical cytologic smear report of atypical glandular cells of undetermined significance (AGUS) or atypical squamous cells of undetermined significance (ASCUS). Cervical cytologic smear report of low-grade squamous intraepithelial lesion (SIL) or greater, CIN1 or greater, or any reported dysplasia; Subjects with ASCUS are eligible only if high risk human papilloma virus (HPV) result is negative. 2. Unresolved findings suspicious for malignancy on the breast exam; incomplete mammogram result (BI-RADS 0) or unresolved findings suggestive of malignant changes or findings requiring short interval follow-up on the prestudy mammogram (subjects must have mammography result of BI-RADS 1 or 2 to enroll.) Mammogram may be performed within 9 months prior to Visit 2 (randomization) with documentation available. (The site must obtain a copy of the official report for the subject's study file, and it must be verified that the mammogram itself is available if needed for additional assessment); 3. In subjects with intact uterus: have a screening endometrial biopsy sample that is found by both primary pathologists to have endometrial tissue insufficient for diagnosis, no endometrium identified, or no tissue identified. (With the approval of the Medical Monitor, the screening endometrial biopsy may be repeated once); 4. In subjects with intact uterus: an endometrial biopsy report by one central pathologist at screening with one of the following:

- Endometrial hyperplasia endometrial cancer, proliferative endometrium,

weakly proliferative endometrium, disordered proliferative pattern; OR

- Endometrial polyps with hyperplasia, glandular atypia of any degree (e. g.,

atypical nuclei) or cancer; 5. Vulvar or vaginal inflammatory condition such as a contact or allergic dermatitis, lichen sclerosis or other pathological findings; 6. Presence of suspicious vulvar or vaginal lesions for dysplasia, malignancy or other pathology other than atrophy; 7. Painful genital warts or localized areas of ulceration; 8. A history of active, chronic pelvic pain; 9. Interstitial cystitis; 10. Serum alanine aminotransferase (ALT) or serum aspartate aminotransferase (AST) greater than 1. 5 times the upper limit of normal for the laboratory used; 11. Fasting total cholesterol greater than 300 mg/dL (7. 77 mmol/L) or triglycerides greater than 300 mg/dL (3. 39 mmol/L); 12. Fasting blood glucose greater than 125 mg/dL (6. 94 mmol/L) with a hemoglobin A1C of greater than or equal to 6. 5%; 13. Uncontrolled hypertension; subjects with elevated sitting blood pressure, greater than 140 mm Hg systolic or greater than 90 mm Hg diastolic and may not be using more than 2 antihypertensive medications for the treatment of hypertension; 14. Clinically significant abnormal 12-lead ECG (such as myocardial infarction or other findings suggestive of ischemia) 9. Be known to be pregnant or have a positive urine pregnancy test. (Note: A pregnancy test is not required for subjects who have had bilateral tubal ligation, bilateral oophorectomy, hysterectomy, or are 55 years old or greater and have experienced cessation of menses for at least 1 year. 10. Current use of marijuana.

Locations and Contacts

Center for Research Saint-Louis, Quebec G1W4R4, Canada

Clinique RSF Inc., Quebec G1S 2L6, Canada

Medical Affiliated Research Center, Huntsville, Alabama 35801, United States

Montogomery Women's Health, Montgomery, Alabama 36117, United States

Cactus Clinical Research, Meza, Arizona 85209, United States

Arizona Wellness Center for Women, Phoenix, Arizona 85032, United States

Radiant Research, Scottsdale, Arizona 85251, United States

Visions Clinical Research - Tucson, Tucson, Arizona 85712, United States

Sutter East Bay Medical Foundation, Berkeley, California 94705, United States

Torrance Clinical Research Institute Inc, Lomita, California 90717, United States

Futura Research, Norwalk, California 90650, United States

Northern California Research, Sacramento, California 95821, United States

Medical Center for Clinical Research, San Diego, California 92108, United States

San Diego Sexual Medicine, San Diego, California 92120, United States

Women's Health Care Research Corp., San Diego, California 92123, United States

Lynn Institute of the Rockies, Colorado Springs, Colorado 80909, United States

Downtown Women's Health Care, Denver, Colorado 80209, United States

Horizons Clinical Research Center, Denver, Colorado 80220, United States

Red Rocks OB/Gyn, Lakewood, Colorado 80228, United States

Clinical Research Consulting, Milford, Connecticut 06460, United States

Coastal Connecticut Research, LLC, New London, Connecticut 06320, United States

James A. Simon, Women's Health & Research Consultants, Washington, District of Columbia 20036, United States

South Florida Medical Research, Aventura, Florida 33180, United States

Nature Coast Clinical Research, Crystal River, Florida 34429, United States

Avail Clinical Research, DeLand, Florida 32720, United States

Clinical Physiology Associates, Fort Myers, Florida 33916, United States

UF Health Physicians Women's & REI Springhill, Gainesville, Florida 32606, United States

Jacksonville Center for Clinical Research, Jacksonville, Florida 32216, United States

UF College of Medicine-Jacksonville, Dept. of Obstetrics and Gynecology, Jacksonville, Florida 32207, United States

South Florida Wellness & Clinical Research Institute, Margate, Florida 33063, United States

New Age Medical Research Corporation, Miami, Florida 33186, United States

Suncoast Clinical Research, Inc., New Port Richey, Florida 34652, United States

Ideal Clinical Research, North Miami Beach, Florida 33162, United States

Healthcare Clinical Data, North Miami, Florida 33161, United States

Radiant Research, Pinellas Park, Florida 33781, United States

All Women's Healthcare of West Broward, Plantation, Florida 33324, United States

Physician Care Clinical Research, Sarasota, Florida 34239, United States

Comprehensive Clinical Trials, West Palm Beach, Florida 33409, United States

Women's Health Associates, Atlanta, Georgia 30342, United States

Masters of Clinical Research, Inc., Augusta, Georgia 30909, United States

Soapstone Center for Clinical Research, Decatur, Georgia 30034, United States

WR-Mount Vernon Clinical Research, Sandy Springs, Georgia 30328, United States

Fellows Research Alliance, Inc., Savannah, Georgia 31046, United States

Advanced Clinical Research, Boise, Idaho 83642, United States

Women's Healthcare Associates P.A., Idaho Falls, Idaho 83404, United States

Radiant Research, Chicago, Illinois 60654, United States

American Health Network of Indiana, LLC, Avon, Indiana 46123, United States

Lafayette Clinical Research Group, Lafayette, Indiana 47905, United States

Cypress Medical Research Center, Wichita, Kansas 67226, United States

Central Kentucky Research Associates, Inc., Lexington, Kentucky 40509, United States

Bluegrass Clinical Research, Inc., Louisville, Kentucky 40291, United States

Horizon Research Group of Opelousas, Eunice, Louisiana 70535, United States

Capital Women's Care, Frederick, Maryland 21702, United States

Maryland Center for Sexual Health, Lutherville, Maryland 21093, United States

ClinSite, LLC, Ann Arbor, Michigan 48106, United States

Beyer Research, Kalamazoo, Michigan 49009, United States

Saginaw Valley Medical Research Group, L.L.C., Saginaw, Michigan 48604, United States

Montana Health, Billings, Montana 59102, United States

Women's Clinic of Lincoln, Lincoln, Nebraska 68510, United States

Office of Edmond E. Pack, MD, Las Vegas, Nevada 89113, United States

Office of R. Garn Mabey, MD, Las Vegas, Nevada 89128, United States

Lawrence OB-GYN Clinical Research, LLC, Lawrenceville, New Jersey 08648, United States

Rutgers-Robert Wood Johnson Medical School, New Brunswick, New Jersey 08901, United States

Women's Health Research Center, Plainsboro, New Jersey 08536, United States

Bosque Women's Care, Albuquerque, New Mexico 87109, United States

Southwest Clinical Research, Albuquerque, New Mexico 87109, United States

Columbia University Medical Center, New York, New York 10032, United States

Suffolk OB/GYN, Port Jefferson, New York 08536, United States

Women's Wellness Clinic, Durham, North Carolina 27713, United States

Pinewest OB-GYN, Inc., High Point, North Carolina 27262, United States

Wake Research Associates, Raleigh, North Carolina 27612, United States

Hawthorne Research, Winston-Salem, North Carolina 27103, United States

Lyndhurst Clinical Research, Winston-Salem, North Carolina 27103, United States

Lillestol Research, Fargo, North Dakota 58103, United States

Radiant Research, Akron, Ohio 44311, United States

University of Cincinnati Physicians Company, Cincinnati, Ohio 45267-0457, United States

Rapid Medical Research, Cleveland, Ohio 44122, United States

Columbus Center for Women's Health Research, Columbus, Ohio 43213, United States

HWC Women's Research Center, Englewood, Ohio 45322, United States

Landerbrook Health Center, Mayfield Heights, Ohio 44124, United States

Sunstone Medical Research, Medford, Oregon 97504, United States

The Clinical Trial Center, Jenkintown, Pennsylvania 19046, United States

Clinical Research of Philadelphia, Philadelphia, Pennsylvania 19114, United States

Clinical Trials Research Services, Pittsburgh, Pennsylvania 15206, United States

Diex Research Montreal Inc., Montreal, Quebec H4N 3C5, Canada

Diex Research Sherbrooke Inc., Sherbrooke, Quebec J1H 1Z1, Canada

Manna Research Inc, St-Romuald, Quebec G6W 5M6, Canada

Fellows Research Alliance, Inc., Bluffton, South Carolina 29910, United States

Vista Clinical Research, Columbia, South Carolina 29201, United States

Coastal Carolina Research Center, Mt. Pleasant, South Carolina 29464, United States

Chattanooga Medical Research, Chattanooga, Tennessee 37404, United States

Advanced Research Associates, Corpus Christi, Texas 78414, United States

Research Across America, Dallas, Texas 75234, United States

UT Southwestern Medical Center, Dallas, Texas 75390-9032, United States

Advances in Health, Houston, Texas 77030, United States

Hwca, Pllc, Houston, Texas 77054, United States

TMC Life Research, Houston, Texas 77054, United States

Stone Oak, LLC dba Discovery Clinical Trials, San Antonio, Texas 78258, United States

Clinical Research Center, EVMS, Norfolk, Virginia 23507, United States

National Clinical Research-Norfolk, Norfolk, Virginia 23502, United States

National Clinical Research-Richmond, Inc, Richmond, Virginia 23294, United States

Virginia Women's Center, Inc., Richmond, Virginia 23233, United States

Tidewater Clinical Research, Virginia Beach, Virginia 23456, United States

Seattle Women's Health, Research, and Gynecology, Seattle, Washington 98105, United States

North Spokane Women's Health, Spokane, Washington 99207, United States

Additional Information

Starting date: September 2014
Last updated: June 15, 2015

Page last updated: August 23, 2015

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