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

NCT02770365 | Completed Phase 3 Results

• 1 other identifier: PRG-NY-15-007
• Study Type: interventional
• Target: 695
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrophy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Most Bothersome Symptom

  Day 8

Study Arms (3)

Test Product

EXPERIMENTAL

estradiol cream

Drug: estrace cream (Perrigo)

Reference Product

ACTIVE COMPARATOR

estradiol cream

Drug: estrace cream (Reference)

Placebo product

PLACEBO COMPARATOR

Placebo cream

Drug: Placebo cream

Interventions

estrace cream (Perrigo) DRUG

Also known as: Perrigo product

Test Product

estrace cream (Reference) DRUG

Also known as: Reference Listed Drug product

Reference Product

Placebo cream DRUG

Placebo product

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Padagis LLC: lead
• Impax Laboratories, LLC: collaborator

Study Sites (1)

Comprehensive Clinical Trials, LLC

West Palm Beach, Florida, 33409, United States

Location

MeSH Terms

Conditions

Atrophy

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Associate Director
• Organization: Perrigo

jonathan.schwartz@perrigo.com

718-960-9900

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: May 10, 2016
• First Posted: May 12, 2016
• Study Start: May 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: November 2, 2021
• Results First Posted: August 11, 2020

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)