Study to Evaluate the Equivalence of Estradiol Vaginal Cream to Reference Standard in the Treatment of Vaginal Atrophy

NCT03332303 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 71759501
• Study Type: interventional
• Target: 540
• Locations: 1 country
• Sites: 27

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.

Conditions

Vulvar and Vaginal Atrophy

Keywords

Vaginal Dryness; Vaginal and/or Vulvar Irritation/Itching; Dysuria; Vaginal Pain and Bleeding

Outcome Measures

Primary Outcomes (1)

• The Primary Efficacy Endpoint

  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.

  Study Day 8 or Study Day 9

Secondary Outcomes (1)

• The Secondary Efficacy Endpoint

  Study Day 8 or Study Day 9

Other Outcomes (1)

• Duration of Post-menopausal Status (Years)

  Visit 1 (Day - 28 to Day -1)

Study Arms (3)

Experimental: Estradiol Vaginal Cream, USP, 0.01% (Prasco LLC)

EXPERIMENTAL

Estradiol Vaginal Cream, USP, 0.01%, administered once daily for 7 days. Intervention: Drug: Estradiol Vaginal Cream, USP, 0.01%

Drug: Estradiol Vaginal Cream

Active Comparator: Estrace® Cream

ACTIVE COMPARATOR

Estrace® Cream (Estradiol Vaginal Cream, USP, 0.01%), administered once daily for 7 days. Intervention: Drug: Estrace® Cream (Estradiol Vaginal Cream, USP, 0.01%)

Drug: Estrace® Cream

Placebo Comparator: Placebo (Test vehicle cream) Vaginal Cream

PLACEBO COMPARATOR

Placebo (Test vehicle cream) Vaginal Cream, administered once daily for 7 days. Intervention: Drug: Placebo (Test vehicle cream) Vaginal Cream

Drug: Vehicle Cream

Interventions

Estrace® Cream DRUG

Estrace® Cream

Also known as: Estradiol Vaginal Cream

Active Comparator: Estrace® Cream

Estradiol Vaginal Cream DRUG

Estradiol Vaginal Cream

Experimental: Estradiol Vaginal Cream, USP, 0.01% (Prasco LLC)

Vehicle Cream DRUG

Vehicle Cream

Also known as: Placebo

Placebo Comparator: Placebo (Test vehicle cream) Vaginal Cream

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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
• Vaginal and/or Vulvar Irritation/Itching
• Dysuria
• Vaginal Pain associated with sexual activity
• Vaginal Bleeding associated with sexual activity (presence or absence)
• Provided that patient is currently sexually active and plans to remain so throughout the study.

You may not qualify if:

• 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.
• Any prescription treatment for vaginal dryness/irritation within 14 days before Screening or any over-the-counter or natural remedies within 7 days before Screening.
• Any prescription treatment for bacterial or yeast infections within 30 days before Screening.
• Fasting triglyceride levels \> 350 mg/dL.
• History of radiation therapy or recent (within previous 6 weeks) surgical therapy to the vaginal or cervical areas.
• Any known or suspected allergies that, in the Investigator's opinion, would compromise the safety of the patient.

Sponsors & Collaborators

• Prasco LLC: lead

Study Sites (27)

Douglas Young, MD

Sacramento, California, 95821, United States

Location

Medical Center for Clinical Research

San Diego, California, 92108, United States

Location

Women's Health Care Research Corp.

San Diego, California, 92111, United States

Location

Downtown Women's Health Care

Denver, Colorado, 80209, United States

Location

Avail Clinical Research, LLC

DeLand, Florida, 32720, United States

Location

Health Awareness, Inc.

Jupiter, Florida, 33458, United States

Location

New Age Medical Research Corporation

Miami, Florida, 33186, United States

Location

Panax Clinical Research

Miami Lakes, Florida, 33014, United States

Location

Suncoast Clinical Research

New Port Richey, Florida, 34652, United States

Location

Ormond Medical Arts Pharmaceutical Research Center

Ormond Beach, Florida, 32174, United States

Location

Health Awareness, Inc.

Port Saint Lucie, Florida, 34952, United States

Location

Physician Care Clinical Research, LLC

Sarasota, Florida, 34239, United States

Location

Well Pharma Medical Research Group

South Miami, Florida, 33143, United States

Location

Meridien Research, Inc.

St. Petersburg, Florida, 33709, United States

Location

Comprehensive Clinical Trials, LLC

West Palm Beach, Florida, 33409, United States

Location

Cypress Medical Research Center, LLC

Wichita, Kansas, 67226, United States

Location

Praetorian Pharmaceutical

Marrero, Louisiana, 70072, United States

Location

Southern Clinical Research Associates

Metairie, Louisiana, 70001, United States

Location

Canton Obstetrics and Gynecology

Canton, Michigan, 48187, United States

Location

Beyer Research

Kalamazoo, Michigan, 49009, United States

Location

Women's Clinic of Lincoln

Lincoln, Nebraska, 68510, United States

Location

Lawrence Ob-Gyn Clinical Research, LLC

Lawrenceville, New Jersey, 08648, United States

Location

Aventiv Research, Inc.

Columbus, Ohio, 43213, United States

Location

Novum PRS

Pittsburgh, Pennsylvania, 15219, United States

Location

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, 29464, United States

Location

Vernon & Waldrep OBGYN Associates

Dallas, Texas, 75230, United States

Location

Women's Clinical Research Center dba Seattle Women's Health, Research, Gynecology

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Pruritus; Dysuria; Hemorrhage

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lower Urinary Tract Symptoms; Urological Manifestations; Pathologic Processes

Results Point of Contact

• Title: Senior Director, Quality Assurance
• Organization: Prasco LLC

b.inskeep@prasco.com

513-618-3333

Study Officials

• Gail Gongas

  Novum

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2017
• First Posted: November 6, 2017
• Study Start: October 26, 2017
• Primary Completion: March 15, 2018
• Study Completion: March 15, 2018
• Last Updated: May 30, 2024
• Results First Posted: May 30, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (27)