An Exploratory Investigation to Identify if Dame Product'... | NCT05130411

Studies
An Exploratory Investigation to Identify if Dame Product's "DLM" Works to Improve Sexual Desire and Mood in Females

NCT05130411

Sponsor

Dame Products, Inc.

Status

Completed

Last Update Posted

Jan 10, 2022Actual

Enrollment

55Actual

Phase

Not Applicable

Conditions

Sexual Desire Disorder

Interventions

DLM - Test product

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

Jan 2022

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

Oct 15, 2021Actual

Primary Completion Date

Dec 31, 2021Actual

Completion Date

Dec 31, 2021Actual

First Submitted Date

Nov 2, 2021

First Submission Date that Met QC Criteria

Nov 18, 2021

First Posted Date

Nov 23, 2021Actual

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

Jan 5, 2022

Last Update Posted Date

Jan 10, 2022Actual

Name	Class
Citruslabs	INDUSTRY

Description Module

Brief Summary

This is a single-group, non-randomized, non-controlled, open-label observational trial to study and evaluate the efficacy of a commercial dietary supplement, called "DLM" ("test product"). It is hypothesized that the test product, which is designed as an edible gummy, will present a favorable result to increase sexual desire and improve mood.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

55Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DLM - Test product	Experimental	The dietary supplement is designed to be taken in servings of two gummies per day.	Dietary Supplement: DLM - Test product

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DLM - Test product	Dietary Supplement	The group will receive 60 gummies each (to take two gummies per day) across a four-week period. Each participant shall take two gummies per day

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Increase in sexual desire in women and associated improvements of mood and quality of life. [Time Frame: Baseline to 4 weeks)	Survey-based assessment (0-5 scale with 0 being the lowest possible score and 5 being the highest) of changes in sexual desire, mood, and quality of life between baseline and study intervention period.	4 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Females between 24-65 of age
Must be in good health (don't report any medical conditions asked in the screening questionnaire)
Experience sexuality-related personal distress (established in an online-screening questionnaire)
Experience a regular menstrual cycle
In the subject's opinion, previously experienced "normal sexual desire"
Self-reported stress in their daily lives
My present with self-reported anxiety
Trouble being present in the moment
Consider themselves as being busy all the time

Exclusion Criteria:

Current urinary or vaginal infection
Vaginal prolapse and any other disease that could interfere with the study conduction and participation
Diagnosis of depression
Diagnosis of anxiety
Currently experiencing significant symptoms of a mental disorder that might interfere with study participation (e.g. eating disorder, obsessive-compulsive disorder, posttraumatic stress syndrome, bipolar disorder)
Current substance abuse disorder
Diagnosis of an autoimmune disease, such as multiples sclerosis and rheumatoid arthritis
Self-reported or diagnosed hypotension (BP < 90 over 60)
Is currently using, or has used any of the following types of medication within 6 months of screening:

Any for of antidepressants; Mood stabilizers Benzodiazepines ("tranquillizers") Cognitive enhancers or stimulants (e.g. Adderall) The following contraception: Hormonal combination birth control pill; hormonal progesterone-only birth control pill; birth control patch; NuvaRing; Nexplanon Taking insulin or other diabetes medication

Currently, or in the past 6 months, undergoing hormone therapy
Any medical condition that is unstable or uncontrolled
A history of sexual trauma or abuse
Females that are pregnant, want to become pregnant for the duration of the study, or who are breastfeeding

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Born as female

Minimum Age

24 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided