NCT05130411

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2021

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

November 2, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 23, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

January 10, 2022

Status Verified

January 1, 2022

Enrollment Period

3 months

First QC Date

November 2, 2021

Last Update Submit

January 5, 2022

Conditions

Sexual Desire Disorder

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

DLM - Test product

EXPERIMENTAL

The dietary supplement is designed to be taken in servings of two gummies per day.

Dietary Supplement: DLM - Test product

Interventions

DLM - Test productDIETARY_SUPPLEMENT

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

DLM - Test product

Eligibility Criteria

Age24 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsBorn as female
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Citruslabs

Santa Monica, California, 90404, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2021

First Posted

November 23, 2021

Study Start

October 15, 2021

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

January 10, 2022

Record last verified: 2022-01

Locations

US(1)