Exploratory Study on Two Different Doses of VML-0001 on t... | NCT03770065

Studies
Exploratory Study on Two Different Doses of VML-0001 on the Effects on Vaginal pH in Healthy Post-Menopausal Women

NCT03770065

Sponsor

Viramal Limited

Status

Completed

Last Update Posted

Oct 6, 2020Actual

Enrollment

14Actual

Phase

Not provided

Conditions

Vaginal Atrophy

Interventions

VML-0001

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 19, 2018Actual

Primary Completion Date

Dec 30, 2019Actual

Completion Date

Apr 8, 2020Actual

First Submitted Date

Dec 4, 2018

First Submission Date that Met QC Criteria

Dec 7, 2018

First Posted Date

Dec 10, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 5, 2020

Last Update Posted Date

Oct 6, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study is designed to determine the effect on vaginal pH and the duration of action measured on the ability of the base formulation to reduce the vaginal pH

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A			Device: VML-0001
Group B			Device: VML-0001

Interventions

Name	Type	Description	Arm Group Labels	Other Names
VML-0001	Device	Medical device	Group A Group B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To determine the duration of action measured on the ability of VML-0001 (base formulation) to reduce vaginal pH.	The Vaginal pH will be measured daily for 7 days after single dose of VML-0001 using pH kits.	7-14 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

be greater than 45 years
no positive findings on screening gynaecological examination
negative smear test within the last 5 years

Exclusion Criteria:

has signs of vaginal infection
has evidence of alcohol abuse
has used hormonal replacement therapy in three months prior to study entry

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Healthy post-menopausal women

Minimum Age

45 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Healthy Post-Menopausal women

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
James Murray, MD	Doctor	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical Affiliated Research Center, Inc. (MARC)		Huntsville	Alabama	35801	United States