NCT05130411CompletedNot Applicable
An Exploratory Investigation to Identify if Dame Product's "DLM" Works to Improve Sexual Desire and Mood in Females
Dame Products, Inc.1 site in 1 country55 target enrollmentStarted: October 15, 2021Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 55
- Locations
- 1
- Primary Endpoint
- Increase in sexual desire in women and associated improvements of mood and quality of life. [Time Frame: Baseline to 4 weeks)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 24 Years to 65 Years (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
DLM - Test product
Experimental
The dietary supplement is designed to be taken in servings of two gummies per day.
Intervention: DLM - Test product (Dietary Supplement)
Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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