Vaginal HealthNCT06516757
A Single Group Study to Evaluate the Effects of a Boric Acid Suppository on Vaginal Health.
A study testing Boric Acid Suppository in people with Vaginal Health and Bacterial Vaginosis, run by Love Wellness at 1 site in United States.
Trial summary
This is a virtual single-group clinical trial that will last 12 weeks. Participants will use The Killer® (Boric Acid Suppositories) once daily for 7 consecutive days when they feel that they are experiencing any of the common signs of vaginal imbalance like vaginal malodor, vaginal irritation, and/or vaginal itching. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vaginal Health, Bacterial Vaginosis
- What is being tested?
- Boric Acid Suppository
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2024to 5 Jul 2024
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female at birth
- Aged 18+
- Interested in maintaining a calm, soothed, and healthy vaginal environment and balanced vaginal pH levels
- Regularly experience atypical vaginal smell, discharge, itching, swelling, irritation, pain or - burning during sex, and/or a burning sensation while urinating
- Willing to avoid introducing any products or new forms of prescription medication or supplements targeting vaginal health during the study period
- Has used a boric acid suppository before
- Willing to avoid the use of any intra-vaginal products during the study product use
- Willing and able to follow the study protocol
Who cannot join
- Surgeries or invasive treatments in the last six months or planned during the study period
- Introduced any products or forms of prescription medication or supplements targeting vaginal health in the last 12 weeks
- Known allergies to the product ingredients
- Diagnosed with chronic health conditions impacting participation
- Pregnant, breastfeeding, or trying to conceive
- History of substance abuse
Show all 9Show fewer
- Current or former smoker within the past six months
- Unwilling to follow the study protocol
- Currently participating in any other clinical trial or perception study
Trial locations and contacts
1 site in 1 country.
About this study
This is a virtual single-group clinical trial that will last 12 weeks. Participants will use The Killer® (Boric Acid Suppositories) once daily for 7 consecutive days when they feel that they are experiencing any of the common signs of vaginal imbalance like vaginal malodor, vaginal irritation, and/or vaginal itching. Participants will complete a questionnaire before using the product and on Days 3 and 7 of using the product. They will also complete a vaginal swab pH test before using the product and after 7 days of using the product (Day 8).
- Conditions
- Vaginal Health, Bacterial Vaginosis
- Being tested
- Boric Acid Suppository
- Keywords
- Vaginal pH Balance, Vaginal Flora, Women's Health
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boric Acid SuppositoryDietary supplement
Also called The Killer®
Participants will complete a baseline questionnaire and a vaginal pH test before using the product, and additional questionnaires and a pH test after 3 and 7 days of product use.
| Study group | Role | What they receive |
|---|---|---|
| Boric Acid Suppository Group | Experimental | Participants will use 600 mg Boric Acid Gelatin Capsules (The Killer®) once daily for 7 consecutive days when they feel they are experiencing any signs of vaginal imbalance such as vaginal malodor, irritation, and/or itching. Receives: Dietary Supplement: Boric Acid Suppository |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal Health and Balance
Evaluation of vaginal health and balance via participant questionnaires.
Measured: Baseline, Day 3, Day 7, and Day 8
Vaginal Health and Balance
Vaginal pH testing
Measured: Baseline, and Day 8
Secondary outcomes (1)
Participant Perception of Product Convenience
Assessment of participant perception of the convenience of the boric acid suppository compared to other boric acid suppositories via questionnaires.
Measured: Day 3 and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start5 Apr 2024
- Primary completion5 Jul 2024
- Study completion5 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal HealthStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Love Wellness
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06516757
- Sponsor's protocol ID
- 20412
- Status last verified
- Jul 2024
- First submitted
- 11 Jul 2024
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Group Study to Evaluate the Effects of a Boric Acid Suppository on Vaginal Health.
- ClinicalTrials.gov ID
- NCT06516757
- Acronym / sponsor ID
- 20412
- Conditions
- Vaginal Health, Bacterial Vaginosis
- Keywords
- Vaginal pH Balance, Vaginal Flora, Women's Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Love WellnessIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 5 Apr 2024 (actual)
- Primary completion
- 5 Jul 2024 (actual)
- Study completion
- 5 Jul 2024 (actual)
- First posted
- 24 Jul 2024 (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 virtual single-group clinical trial that will last 12 weeks. Participants will use The Killer® (Boric Acid Suppositories) once daily for 7 consecutive days when they feel that they are experiencing any of the common signs of vaginal imbalance like vaginal malodor, vaginal irritation, and/or vaginal itching. Participants will complete a questionnaire before using the product and on Days 3 and 7 of using the product. They will also complete a vaginal swab pH test before using the product and after 7 days of using the product (Day 8).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Boric Acid Suppository Group | Experimental | Dietary Supplement: Boric Acid SuppositoryParticipants will use 600 mg Boric Acid Gelatin Capsules (The Killer®) once daily for 7 consecutive days when they feel they are experiencing any signs of vaginal imbalance such as vaginal malodor, irritation, and/or itching. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female at birth
- Aged 18+
- Interested in maintaining a calm, soothed, and healthy vaginal environment and balanced vaginal pH levels
- Regularly experience atypical vaginal smell, discharge, itching, swelling, irritation, pain or - burning during sex, and/or a burning sensation while urinating
- Willing to avoid introducing any products or new forms of prescription medication or supplements targeting vaginal health during the study period
Key exclusion criteria (9 listed)
- Surgeries or invasive treatments in the last six months or planned during the study period
- Introduced any products or forms of prescription medication or supplements targeting vaginal health in the last 12 weeks
- Known allergies to the product ingredients
- Diagnosed with chronic health conditions impacting participation
- Pregnant, breastfeeding, or trying to conceive
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 |
|---|---|---|
| Boric Acid SuppositoryAlso: The Killer®Participants will complete a baseline questionnaire and a vaginal pH test before using the product, and additional questionnaires and a pH test after 3 and 7 days of product use. | Dietary supplement | Boric Acid Suppository Group |
Primary outcome
Vaginal Health and Balance
Time frame: Baseline, Day 3, Day 7, and Day 8
Evaluation of vaginal health and balance via participant questionnaires.
Vaginal Health and Balance
Time frame: Baseline, and Day 8
Vaginal pH testing
1 secondary outcome
Participant Perception of Product Convenience
Time frame: Day 3 and Day 7
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 24 Jul 2024.
- Individual participant dataSharing planned: No
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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 Boric Acid Suppository in people with Vaginal Health and Bacterial Vaginosis, run by Love Wellness 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 8 inclusion and 9 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 24 Jul 2024. 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?
Vaginal Health and Balance (time frame: Baseline, Day 3, Day 7, and Day 8). The study lists 2 primary outcomes in all. 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 24 Jul 2024.