Study to Evaluate the Equivalence of Estradiol Vaginal Cream to Reference Standard in the Treatme… (NCT03332303) | Clinical Trial Compass
CompletedPhase 3
Study to Evaluate the Equivalence of Estradiol Vaginal Cream to Reference Standard in the Treatment of Vaginal Atrophy
United States540 participantsStarted 2017-10-26
Plain-language summary
The objectives of this study are to evaluate the therapeutic equivalence of the Test formulation, Estradiol Vaginal Cream 0.01% (Prasco, LLC) to the marketed product, Estrace® Cream (estradiol vaginal cream, 0.01%) in patients with vulvar and vaginal atrophy, and compare the safety of Test, Reference and Placebo treatments in patients with vulvar and vaginal atrophy.
Who can participate
Age range30 Years – 75 Years
SexFEMALE
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Inclusion criteria
✓. Signed IRB-approved informed consent form that meets all criteria of current FDA regulations.
✓. Postmenopausal females aged 30-75 years inclusive. Postmenopausal is defined as follows:
✓. At least 6 months of spontaneous amenorrhea.
✓. At least 6 weeks post-surgical bilateral oophorectomy, with or without hysterectomy.
✓. Hysterectomy without oophorectomy if of age that the Investigator believes would have naturally reached 12 months of spontaneous amenorrhea if uterus had remained intact.
✓. Patients with a serum Follicle Stimulating Hormone (FSH) level of ≥ 40 mIU/mL at Screening.
✓. Have ≤ 5% superficial cells on vaginal smear cytology.
✓. Have a vaginal pH \> 5.0.
Exclusion criteria
✕. Significant history or current evidence of chronic infectious disease, system disorder, organ disorder or other medical condition that in the Investigator's opinion would place the study patient at undue risk by participation or could jeopardize the integrity of the study evaluations.
✕. Any clinically significant laboratory finding that, in the Investigator's opinion would contraindicate the use of estradiol or compromise patient safety.
✕. Patients with known concurrent vaginal infections including but not limited to: Candida albicans, Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhea or Gardnerella vaginalis.