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

Sexual Desire Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05130411
• Other study ID #: 20217-Dame
• Status: Completed
• Phase: N/A
• Start date: October 15, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2022
• Source: Dame Products, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 24 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Sexual Desire Disorder

Intervention

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

Locations

Country	Name	City	State
United States	Citruslabs	Santa Monica	California

Sponsors (2)

Lead Sponsor	Collaborator
Dame Products, Inc.	Citruslabs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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