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

Study Overview
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Brief Summary
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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.

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

Conditions
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Sexual Desire Disorder

Intervention / Treatment
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* Dietary Supplement: DLM - Test product


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 24 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 |