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

NCT ID: NCT02770365

Last Updated: 2021-11-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

695 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2016-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Atrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Test Product

estradiol cream

Group Type EXPERIMENTAL

estrace cream (Perrigo)

Intervention Type DRUG

Reference Product

estradiol cream

Group Type ACTIVE_COMPARATOR

estrace cream (Reference)

Intervention Type DRUG

Placebo product

Placebo cream

Group Type PLACEBO_COMPARATOR

Placebo cream

Intervention Type DRUG

Interventions

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estrace cream (Perrigo)

Intervention Type DRUG

estrace cream (Reference)

Intervention Type DRUG

Placebo cream

Intervention Type DRUG

Other Intervention Names

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Perrigo product Reference Listed Drug product

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Impax Laboratories, LLC

INDUSTRY

Sponsor Role collaborator

Padagis LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Comprehensive Clinical Trials, LLC

West Palm Beach, Florida, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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PRG-NY-15-007

Identifier Type: -

Identifier Source: org_study_id