Comparative Safety and Efficacy of Two Treatments in the Treatment of Vulvar and Vaginal Atrophy
Primary Purpose
Atrophy
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
estrace cream (Perrigo)
estrace cream (Reference)
Placebo cream
Sponsored by
About this trial
This is an interventional treatment trial for Atrophy
Eligibility Criteria
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
Sites / Locations
- Comprehensive Clinical Trials, LLC
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Test Product
Reference Product
Placebo product
Arm Description
estradiol cream
estradiol cream
Placebo cream
Outcomes
Primary Outcome Measures
Percentage of Subjects Identified as Responders
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.
Secondary Outcome Measures
Most Bothersome Symptom
Percentage of subjects based on the improvement (change from Visit 2) of the Most Bothersome Symptom at Visit 3.
Full Information
NCT ID
NCT02770365
First Posted
May 10, 2016
Last Updated
October 29, 2021
Sponsor
Padagis LLC
Collaborators
Impax Laboratories, LLC
1. Study Identification
Unique Protocol Identification Number
NCT02770365
Brief Title
Comparative Safety and Efficacy of Two Treatments in the Treatment of Vulvar and Vaginal Atrophy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Padagis LLC
Collaborators
Impax Laboratories, LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
695 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test Product
Arm Type
Experimental
Arm Description
estradiol cream
Arm Title
Reference Product
Arm Type
Active Comparator
Arm Description
estradiol cream
Arm Title
Placebo product
Arm Type
Placebo Comparator
Arm Description
Placebo cream
Intervention Type
Drug
Intervention Name(s)
estrace cream (Perrigo)
Other Intervention Name(s)
Perrigo product
Intervention Type
Drug
Intervention Name(s)
estrace cream (Reference)
Other Intervention Name(s)
Reference Listed Drug product
Intervention Type
Drug
Intervention Name(s)
Placebo cream
Primary Outcome Measure Information:
Title
Percentage of Subjects Identified as Responders
Description
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.
Time Frame
Day 8
Secondary Outcome Measure Information:
Title
Most Bothersome Symptom
Description
Percentage of subjects based on the improvement (change from Visit 2) of the Most Bothersome Symptom at Visit 3.
Time Frame
Day 8
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Comprehensive Clinical Trials, LLC
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparative Safety and Efficacy of Two Treatments in the Treatment of Vulvar and Vaginal Atrophy
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