Sexual Desire Disorder
Conditions
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.
Interventions
DIETARY_SUPPLEMENTDLM - 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
Sponsors
Citruslabs
Dame Products, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
24 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed