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

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.

Study Overview

• Status: Completed
• Conditions: Sexual Desire Disorder
• Intervention / Treatment: Dietary supplement: DLM - Test product

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Monica, California, United States, 90404
      • Citruslabs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 24 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DLM - Test product; The dietary supplement is designed to be taken in servings of two gummies per day.	Dietary supplement: DLM - Test product; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Dame Products, Inc.
• Collaborators: Citruslabs

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2021
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: November 2, 2021
• First Submitted That Met QC Criteria: November 18, 2021
• First Posted (Actual): November 23, 2021

Study Record Updates

• Last Update Posted (Actual): January 10, 2022
• Last Update Submitted That Met QC Criteria: January 5, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 20217-Dame

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No