Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multi-Site Study to Evaluate Therapeutic Equivalence of Estradiol Vaginal Cream, USP, 0.01% (Prasco LLC) to Estrace® Cream (Warner Chilcott) in Treatment of Vulvar and Vaginal Atrophy
Overview
- Phase
- Phase 3
- Intervention
- Estradiol Vaginal Cream
- Conditions
- Vulvar and Vaginal Atrophy
- Sponsor
- Prasco LLC
- Enrollment
- 540
- Locations
- 26
- Primary Endpoint
- The Primary Efficacy Endpoint
- Status
- Completed
- Last Updated
- last year
Overview
Brief 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.
Investigators
Eligibility Criteria
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.
- •At least one of the following patient self-assessed moderate to severe symptoms of VVA from the following list that is identified by the patient as being the most bothersome to her:
- •Vaginal Dryness
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.
- •Patients with active vaginal herpes simplex infection or have had an outbreak within 30 days before the Screening.
- •Patients with known, suspected or current history of carcinoma of the breast.
- •Patients with baseline systolic blood pressure of \> 150 mmHg and/or diastolic pressure \> 90 mmHg.
- •Any patient with past or current undiagnosed vaginal bleeding or significant risk factors for endometrial cancer.
- •Any history of estrogen-dependent neoplasia (e.g., endometrial cancer).
- •Patients with known, suspected or current history of hormone dependent tumor.
- •History of acute thrombophlebitis or thromboembolic disorder.
Arms & Interventions
Experimental: Estradiol Vaginal Cream, USP, 0.01% (Prasco LLC)
Estradiol Vaginal Cream, USP, 0.01%, administered once daily for 7 days. Intervention: Drug: Estradiol Vaginal Cream, USP, 0.01%
Intervention: Estradiol Vaginal Cream
Active Comparator: Estrace® Cream
Estrace® Cream (Estradiol Vaginal Cream, USP, 0.01%), administered once daily for 7 days. Intervention: Drug: Estrace® Cream (Estradiol Vaginal Cream, USP, 0.01%)
Intervention: Estrace® Cream
Placebo Comparator: Placebo (Test vehicle cream) Vaginal Cream
Placebo (Test vehicle cream) Vaginal Cream, administered once daily for 7 days. Intervention: Drug: Placebo (Test vehicle cream) Vaginal Cream
Intervention: Vehicle Cream
Outcomes
Primary Outcomes
The Primary Efficacy Endpoint
Time Frame: Study Day 8 or Study Day 9
The primary efficacy endpoint is the number of participants in each treatment group that were identified as Responders at the end of the treatment period evaluated on Day 8 or Day 9. A Responder was defined as a participant with at least a 25% reduction from baseline in the sum of % basal/parabasal + % intermediate cells on vaginal cytology AND vaginal pH \< 5.0 with a change from baseline vaginal pH of at least 0.5. Any participant who withdrew from the study because of lack of efficacy was included as a non-responder.
Secondary Outcomes
- The Secondary Efficacy Endpoint(Study Day 8 or Study Day 9)