Trials Sponsors Conditions Drugs Pricing

Conditions

Vulvar and Vaginal Atrophy

Keywords

Vaginal DrynessVaginal and/or Vulvar Irritation/ItchingDysuriaVaginal Pain and Bleeding

Outcome Measures

Primary Outcomes (1)

The Primary Efficacy Endpoint
The primary efficacy endpoint is the number of participants in each treatment group that were identified as Responders at the end of the treatment period evaluated on Day 8 or Day 9. A Responder was defined as a participant with at least a 25% reduction from baseline in the sum of % basal/parabasal + % intermediate cells on vaginal cytology AND vaginal pH \< 5.0 with a change from baseline vaginal pH of at least 0.5. Any participant who withdrew from the study because of lack of efficacy was included as a non-responder.
Study Day 8 or Study Day 9

Secondary Outcomes (1)

The Secondary Efficacy Endpoint
Study Day 8 or Study Day 9

Other Outcomes (1)

Duration of Post-menopausal Status (Years)
Visit 1 (Day - 28 to Day -1)

Study Arms (3)

Experimental: Estradiol Vaginal Cream, USP, 0.01% (Prasco LLC)

EXPERIMENTAL

Estradiol Vaginal Cream, USP, 0.01%, administered once daily for 7 days. Intervention: Drug: Estradiol Vaginal Cream, USP, 0.01%

Drug: Estradiol Vaginal Cream

Active Comparator: Estrace® Cream

ACTIVE COMPARATOR

Estrace® Cream (Estradiol Vaginal Cream, USP, 0.01%), administered once daily for 7 days. Intervention: Drug: Estrace® Cream (Estradiol Vaginal Cream, USP, 0.01%)

Drug: Estrace® Cream

Placebo Comparator: Placebo (Test vehicle cream) Vaginal Cream

PLACEBO COMPARATOR

Interventions

Estrace® CreamDrug

Estrace® Cream

Also known as: Estradiol Vaginal Cream

Active Comparator: Estrace® Cream

Estradiol Vaginal CreamDrug

Estradiol Vaginal Cream

Experimental: Estradiol Vaginal Cream, USP, 0.01% (Prasco LLC)

Eligibility Criteria

Age30 Years - 75 Years

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Signed IRB-approved informed consent form that meets all criteria of current FDA regulations.
Postmenopausal females aged 30-75 years inclusive. Postmenopausal is defined as follows:

Sponsors & Collaborators

Prasco LLC
Industrylead

Study Sites (27)

Douglas Young, MD

Sacramento, California, 95821, United States

Medical Center for Clinical Research

San Diego, California, 92108, United States

Women's Health Care Research Corp.

San Diego, California, 92111, United States

Downtown Women's Health Care

Denver, Colorado, 80209, United States

Avail Clinical Research, LLC

DeLand, Florida, 32720, United States

Health Awareness, Inc.

Jupiter, Florida, 33458, United States

New Age Medical Research Corporation

Miami, Florida, 33186, United States

MeSH Terms

Conditions

PruritusDysuriaHemorrhage

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsLower Urinary Tract SymptomsUrological ManifestationsPathologic Processes

Results Point of Contact

Title: Senior Director, Quality Assurance
Organization: Prasco LLC

Study Officials

Gail Gongas
Novum
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: Yes

Enrollment

540 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 1, 2017

First Posted

November 6, 2017

Study Start

October 26, 2017

Actual (reported)

Study to Evaluate the Equivalence of Estradiol Vaginal Cream to Reference Standard in the Treatment of Vaginal Atrophy

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Other Outcomes (1)

Study Arms (3)

Experimental: Estradiol Vaginal Cream, USP, 0.01% (Prasco LLC)

Active Comparator: Estrace® Cream

Placebo Comparator: Placebo (Test vehicle cream) Vaginal Cream

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (27)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Other Outcomes (1)

Study Arms (3)

Experimental: Estradiol Vaginal Cream, USP, 0.01% (Prasco LLC)

Active Comparator: Estrace® Cream

Placebo Comparator: Placebo (Test vehicle cream) Vaginal Cream

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (27)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations