Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-31 @ 10:38 AM
Study NCT ID:
NCT02995694
Status:
COMPLETED
Last Update Posted:
2021-12-01
First Post:
2016-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Comparing Estradiol Vaginal Cream to Estrace® Cream in Females With Atrophic Vaginitis
Sponsor:
Alvogen Pine Brook LLC
Organization:
Study Overview
Official Title:
Clinical Endpoint Therapeutic Equivalence Multi-Site Study Comparing Estradiol Vaginal Cream (0.01%; Alvogen Pine Brook LLC.) to Estrace® Cream (0.01%; Warner Chilcott) in Postmenopausal Females With Atrophic Vaginitis
Status:
COMPLETED
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the therapeutic equivalence of Alvogen's estradiol vaginal cream to Estrace® cream and superiority of both products to placebo. The protocol describes a randomized, double-blind, multi-dose, placebo-controlled, parallel study of a 7 day treatment.
Detailed Description:
This randomized, double-blind, placebo-controlled, parallel group, multiple-site study was designed to evaluate the therapeutic efficacy and safety of a generic Estradiol Vaginal Cream USP, 0.01% (Alvogen Pine Brook LLC) compared to the FDA Reference Listed Drug (RLD), Estrace® (estradiol vaginal cream USP, 0.01%, Warner Chilcott) in patients with atrophic vaginitis. Additionally, both the Test and the RLD formulations were tested for superiority against a Placebo.
Following the 14-day screening period, patients who continued to meet the inclusion/exclusion criteria were randomized in a 2:2:1 ratio (Test: Reference: Placebo) for 7 days of treatment.
Five hundred and thirty-five (535) patients were randomized to one of the three study products as follows:
* Test: Estradiol Vaginal Cream USP, 0.01% (Alvogen Pine Brook LLC)
* Reference: Estrace® (estradiol vaginal cream USP, 0.01%) (Warner Chilcott)
* Placebo: Test product vehicle cream (Alvogen Pine Brook LLC)
Patients completed up to three clinic visits as follows:
* Visit 1 - Screening: Day -14 to Day -1
* Visit 2 - Randomization: Day 1
* Visit 3 - End of Study: Day 8, maximum Day 10
Study product was self-administered by the patient for 7 days according to the dosing instructions provided. Each patient was required to dose once daily at approximately the me of day for 7 consecutive days.
Following the 14-day screening period, patients who continued to meet the inclusion/exclusion criteria were randomized in a 2:2:1 ratio (Test: Reference: Placebo) for 7 days of treatment.
Five hundred and thirty-five (535) patients were randomized to one of the three study products as follows:
* Test: Estradiol Vaginal Cream USP, 0.01% (Alvogen Pine Brook LLC)
* Reference: Estrace® (estradiol vaginal cream USP, 0.01%) (Warner Chilcott)
* Placebo: Test product vehicle cream (Alvogen Pine Brook LLC)
Patients completed up to three clinic visits as follows:
* Visit 1 - Screening: Day -14 to Day -1
* Visit 2 - Randomization: Day 1
* Visit 3 - End of Study: Day 8, maximum Day 10
Study product was self-administered by the patient for 7 days according to the dosing instructions provided. Each patient was required to dose once daily at approximately the me of day for 7 consecutive days.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: