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

Phase 3

Completed

• Conditions: Atrophy
• Interventions: Drug: estrace cream (Reference); Drug: Placebo cream; Drug: estrace cream (Perrigo)

• Registration Number: NCT02770365
• Lead Sponsor: Padagis LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-10
• Study First Submitted QC: 2016-05-11
• Study First Posted: 2016-05-12
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Disposition First Submitted: 2016-12-15
• Disposition First Submitted QC: 2016-12-15
• Disposition First Posted: 2016-12-16
• Results First Submitted: 2020-05-26
• Results First Submitted QC: 2020-07-28
• Results First Posted: 2020-08-11
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-29
• Last Update Posted: 2021-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 695

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reference Product	estrace cream (Reference)	estradiol cream
Placebo product	Placebo cream	Placebo cream
Test Product	estrace cream (Perrigo)	estradiol cream

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects Identified as Responders	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.

Secondary Outcome Measures

Name	Time	Method
Most Bothersome Symptom	Day 8	Percentage of subjects based on the improvement (change from Visit 2) of the Most Bothersome Symptom at Visit 3.

Trial Locations

Locations (1)

Comprehensive Clinical Trials, LLC; 🇺🇸 West Palm Beach, Florida, United States