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

• Sponsor: Dame Products, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05130411
• Collaborator: Citruslabs (Industry)
• Enrollment: 55
• Location: 1
• Arm: 1
• Actual Duration (Months): 2.5
• Patients Per Site Per Month: 21.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sexual Desire Disorder	Dietary Supplement: DLM - Test product	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 55 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Exploratory Investigation to Identify if Dame Product's "DLM" Works to Improve Sexual Desire and Mood in Females
• Actual Study Start Date: Oct 15, 2021
• Actual Primary Completion Date: Dec 31, 2021
• Actual Study Completion Date: Dec 31, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Increase in sexual desire in women and associated improvements of mood and quality of life. [Time Frame: Baseline to 4 weeks) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 24 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Citruslabs	Santa Monica	California	United States	90404

Sponsors and Collaborators

• Dame Products, Inc.
• Citruslabs

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dame Products, Inc.
• ClinicalTrials.gov Identifier: NCT05130411
• Other Study ID Numbers: 20217-Dame
• First Posted: Nov 23, 2021
• Last Update Posted: Jan 10, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jan 10, 2022