Comparative Safety and Efficacy of Two Treatments in the Treatment of Vulvar and Vaginal Atrophy

October 29, 2021 updated by: Padagis LLC
To compare safety and efficacy of Perrigo's drug product compared to an FDA approved drug product in the treatment of vulvar and vaginal atrophy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

695

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • postmenopausal female and otherwise healthy, 30 - 75 years of age.
  • ≤ 5% superficial cells on vaginal smear cytology at Visit 1/Screening.
  • vaginal pH > 5.0 at Visit 1/Screening
  • Have at least one self-assessed moderate to severe symptom of Vulvar and Vaginal Atrophy identified by the subject as being the most bothersome
  • For women with an intact uterus, vaginal ultrasonography confirmation at Visit 1/Screening of an inactive endometrial lining with an endometrial thickness less than 4 mm.
  • Systolic blood pressure no greater than 150 mm Hg and diastolic blood pressure no greater than 90 mm Hg at Visit 1/Screening and at Visit 2/Randomization

Exclusion Criteria:

  • Undiagnosed vaginal bleeding or a history of significant risk factors for endometrial cancer.
  • Known, suspected, or history of cancer of the breast or mammogram indicating any abnormalities or subject has a history of cervical cancer.
  • Vaginal ultrasonography for all women with an intact uterus confirming endometrial thickness of 4mm or more
  • History of hypersensitivity or allergy to estradiol or any of the other study medication ingredients.
  • Known or suspected estrogen-dependent neoplasia.

  • Has deep vein thrombosis, pulmonary embolism or history of these conditions.

    • Subject has active arterial thromboembolic disease (e. g. stroke, myocardial infarction) or history of these conditions.

  • Known acute or chronic hepatic disease or dysfunction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test Product
estradiol cream
Drug: estrace cream (Perrigo)
Other Names:
  • Perrigo product
Active Comparator: Reference Product
estradiol cream
Drug: estrace cream (Reference)
Other Names:
  • Reference Listed Drug product
Placebo Comparator: Placebo product
Placebo cream
Drug: Placebo cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subjects Identified as Responders
Time Frame: Day 8
A responder is a subject meeting specific vaginal cytology criteria AND a vaginal pH < 5.0 with a change from Visit 1 of at least 0.5.
Day 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Most Bothersome Symptom
Time Frame: Day 8
Percentage of subjects based on the improvement (change from Visit 2) of the Most Bothersome Symptom at Visit 3.
Day 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Padagis LLC

Collaborators

Impax Laboratories, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

May 10, 2016

First Submitted That Met QC Criteria

May 11, 2016

First Posted (Estimate)

May 12, 2016

Study Record Updates

Last Update Posted (Actual)

November 2, 2021

Last Update Submitted That Met QC Criteria

October 29, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRG-NY-15-007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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