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

Completed · Phase 3 · Has a placebo group

Conditions studied: Vulvovaginal Atrophy, Menopause, Dyspareunia, Painful Intercourse

In brief

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.

Key facts

Study ID

NCT02253173

Run by

TherapeuticsMD

People needed

764

Starts

2014-09-01

Expected to finish

2015-10-01

Last updated by the study team

2017-05-25

Who can join

Age: 40 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• ≤5% superficial cells on vaginal cytological smear
• Vaginal pH > 5.0
• Moderate to severe symptom of vaginal pain associated with sexual activity considered the most bothersome vaginal symptom by the subject at screening visit 1A.
• Moderate to severe symptom of vaginal pain associated with sexual activity at screening visit 1B.
• Onset of moderate to severe dyspareunia in the postmenopausal years.
• Subjects should be sexually active (i.e. have sexual activity with vaginal penetration within approximately 1 month of screening visit 1A).
• Subjects should anticipate having sexual activity (with vaginal penetration) during the conduct of the trial.
• For subjects with an intact uterus: Subjects must have an acceptable result from an evaluable screening endometrial biopsy.
• 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).
• In the opinion of the investigator, the subject will comply with the protocol and has a high probability of completing the study.

You may not qualify if…

• Use of the following:
• Oral estrogen-, progestin-, androgen-, or SERM-containing drug products within 8 weeks before screening visit 1A (can enter washout);
• Use of transdermal hormone products within 4 weeks before screening visit 1A (can enter washout);
• Use of vaginal hormone products (rings, creams, gels) within 4 weeks before screening visit1A (can enter washout);
• Use of intrauterine progestins within 8 weeks before screening visit 1A (can enter washout);
• Use of progestin implants/injectables or estrogen pellets/injectables within 6 months before screening visit 1A (cannot enter washout);
• Use of vaginal lubricants or moisturizers within 7 days before the screening visit 1B vaginal pH assessment.
• A history or active presence of clinically important medical disease that might confound the study or be detrimental to the subject, examples include:
• Hypersensitivity to estrogens;
• Endometrial hyperplasia;
• Undiagnosed vaginal bleeding;
• Have a history of a chronic liver or kidney dysfunction/disorder (e.g., Hepatitis C or chronic renal failure);
• Thrombophlebitis, thrombosis or thromboembolic disorders;
• Cerebrovascular accident, stroke, or transient ischemic attack;
• Myocardial infarction or ischemic heart disease;
• 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;
• Endocrine disease (except for controlled hypothyroidism or controlled non-insulin dependent diabetes mellitus).
• Recent history of known alcohol or drug abuse.
• 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.
• Current history of Heavy smoking (more than 15 cigarettes per day) or use of e-cigarettes.
• Use of an intrauterine device within 12 weeks before screening visit 1A.
• Use of an investigational drug within 60 days before screening visit 1A.
• Any clinically important abnormalities on screening physical exam, assessments, ECG, or laboratory tests, such as:
• 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.

Where it is running

• Montogomery Women's Health — Montgomery, Alabama, United States
• Cactus Clinical Research — Mesa, Arizona, United States
• Arizona Wellness Center for Women — Phoenix, Arizona, United States
• Radiant Research — Scottsdale, Arizona, United States
• Visions Clinical Research - Tucson — Tucson, Arizona, United States
• Sutter East Bay Medical Foundation — Berkeley, California, United States
• Torrance Clinical Research Institute Inc — Lomita, California, United States
• Futura Research — Norwalk, California, United States
• Northern California Research — Sacramento, California, United States
• Medical Center for Clinical Research — San Diego, California, United States
• San Diego Sexual Medicine — San Diego, California, United States
• Women's Health Care Research Corp. — San Diego, California, United States
• Lynn Institute of the Rockies — Colorado Springs, Colorado, United States
• Downtown Women's Health Care — Denver, Colorado, United States
• Horizons Clinical Research Center — Denver, Colorado, United States
• Red Rocks OB/Gyn — Lakewood, Colorado, United States
• Clinical Research Consulting — Milford, Connecticut, United States
• Coastal Connecticut Research, LLC — New London, Connecticut, United States
• James A. Simon, Women's Health & Research Consultants — Washington D.C., District of Columbia, United States
• South Florida Medical Research — Aventura, Florida, United States
• Nature Coast Clinical Research — Crystal River, Florida, United States
• Avail Clinical Research — DeLand, Florida, United States
• Clinical Physiology Associates — Fort Myers, Florida, United States
• UF Health Physicians Women's & REI Springhill — Gainesville, Florida, United States
• Medical Affiliated Research Center — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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