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.

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Key information

Conditions

Sexual Desire Disorder

Age range

24 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Citruslabs

Santa Monica, California, 90404, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Dame Products, Inc.

Industry

Collaborators

Citruslabs

Registry information

Important dates

Study start: 2021
Primary completion: 2021
Study completion: 2021
First posted: Nov 23, 2021
Registry last updated: Jan 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed