Clinical trial NCT05130411: An Exploratory Investigation to Identify if Dame Product's "DLM" Works to Improve Sexual Desire and Mood in Females
Official title: An Exploratory Investigation to Identify if Dame Product's "DLM" Works to Improve Sexual Desire and Mood in Females
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Desire Disorder
Lead sponsor: Dame Products, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2021-11-23
Enrollment: 55
Sex: FEMALE
Minimum age (years): 24
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Increase in sexual desire in women and associated improvements of mood and quality of life. [Time Frame: Baseline to 4 weeks)
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
References: