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

Atrophy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02770365
• Other study ID #: PRG-NY-15-007
• Status: Completed
• Phase: Phase 3
• Start date: May 2016
• Est. completion date: November 2016

Study information

• Verified date: October 2021
• Source: Padagis LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 695
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrophy

Intervention

Drug:
• estrace cream (Perrigo)

• estrace cream (Reference)

• Placebo cream

Locations

Country	Name	City	State
United States	Comprehensive Clinical Trials, LLC	West Palm Beach	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Padagis LLC	Impax Laboratories, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 8
Secondary	Most Bothersome Symptom	Percentage of subjects based on the improvement (change from Visit 2) of the Most Bothersome Symptom at Visit 3.	Day 8