Sexual Desire DisorderNCT05130411
An Exploratory Investigation to Identify if Dame Product's "DLM" Works to Improve Sexual Desire and Mood in Females
A study testing DLM - Test product in people with Sexual Desire Disorder, run by Dame Products, Inc. at 1 site in United States.
Trial 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"). Read more about this study
- Who is it for?
- Ages 24 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sexual Desire Disorder
- What is being tested?
- DLM - Test product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2021to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- My present with self-reported anxiety
- Trouble being present in the moment
- Consider themselves as being busy all the time
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Sexual Desire Disorder
- Being tested
- DLM - Test product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| DLM - Test product | Experimental | The dietary supplement is designed to be taken in servings of two gummies per day. Receives: Dietary Supplement: DLM - Test product |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start15 Oct 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual Desire DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dame Products, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05130411
- Sponsor's protocol ID
- 20217-Dame
- Status last verified
- Jan 2022
- First submitted
- 2 Nov 2021
- Last updated
- 10 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Investigation to Identify if Dame Product's "DLM" Works to Improve Sexual Desire and Mood in Females
- ClinicalTrials.gov ID
- NCT05130411
- Acronym / sponsor ID
- 20217-Dame
- Conditions
- Sexual Desire Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Dame Products, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 23 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DLM - Test product | Experimental | Dietary Supplement: DLM - Test productThe dietary supplement is designed to be taken in servings of two gummies per day. |
Who may qualify
- Ages
- 24 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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"
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DLM - Test productThe 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 | Dietary supplement | DLM - Test product |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2022.
- Individual participant dataSharing planned: Undecided. Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DLM - Test product in people with Sexual Desire Disorder, run by Dame Products, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2022.