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

D

Dame Products

Status

Completed

Conditions

Sexual Desire Disorder

Treatments

Dietary Supplement: DLM - Test product

Study type

Interventional

Funder types

Industry

Identifiers

NCT05130411
20217-Dame

Details and patient eligibility

About

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.

Enrollment

55 patients

Sex

Female

Ages

24 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

55 participants in 1 patient group

DLM - Test product
Experimental group
Description:
The dietary supplement is designed to be taken in servings of two gummies per day.
Treatment:
Dietary Supplement: DLM - Test product

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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