Vaginal HealthNCT06565312
A Single Group Study to Evaluate the Effects of a Probiotic Vaginal Suppository on Vaginal Health.
A study testing Flora Power Probiotic Vaginal Suppository in people with Vaginal Health and Vaginal pH, run by Love Wellness at 1 site in United States.
Trial summary
This is a virtual single-group clinical trial lasting 8 weeks to evaluate the effects of a probiotic vaginal suppository on vaginal health. Participants will use the Flora Power suppository daily for 5 consecutive days when experiencing common signs of vaginal imbalance. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vaginal Health, Vaginal pH
- What is being tested?
- Flora Power Probiotic Vaginal 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
- 10 May 2024to 10 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 healthy vaginal environment.
- Experience common signs of vaginal imbalance (e.g., malodor, irritation).
- Willing to avoid other vaginal products and follow study protocol.
Who cannot join
- Recent surgeries or invasive treatments.
- Use of vaginal health products in the last 12 weeks.
- Allergies to product ingredients.
- Chronic health conditions impacting participation.
- Pregnant, breastfeeding, or trying to conceive.
- History of substance abuse or smoking.
- Currently participating in another clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
This is a virtual single-group clinical trial lasting 8 weeks to evaluate the effects of a probiotic vaginal suppository on vaginal health. Participants will use the Flora Power suppository daily for 5 consecutive days when experiencing common signs of vaginal imbalance. They will complete questionnaires and vaginal pH tests before and after product use.
- Conditions
- Vaginal Health, Vaginal pH
- Being tested
- Flora Power Probiotic Vaginal Suppository
- Keywords
- Vaginal suppository, Women's Health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flora Power Probiotic Vaginal SuppositoryDietary supplement
The suppository contains Microcrystalline Cellulose, Ascorbic Acid, Vitamin C, Gelatin Capsule, Vaginal Probiotic Blend (Lactobacillus fermentum LF61, Lactobacillus acidophilus LA85, Lactobacillus plantarum Lp90), Magnesium Stearate, and Silicon Dioxide.
| Study group | Role | What they receive |
|---|---|---|
| Flora Power Probiotic Vaginal Suppository | Experimental | Participants will use the Flora Power suppository once daily at bedtime for 5 consecutive days when they feel they are experiencing any of the common signs of vaginal imbalance like vaginal malodor, vaginal irritation, and/or vaginal itching. Receives: Dietary Supplement: Flora Power Probiotic Vaginal Suppository |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on Vaginal pH and Health
Measure the change in vaginal pH levels with a test strip from baseline to 24 hours after the 5-day intervention period.
Measured: Baseline, Day 6 (24 hours after the last suppository insertion)
Effect on Vaginal pH and Health
Measure the change in overall vaginal health from baseline to 24 hours after the 5-day intervention period with a questionnaire.
Measured: Baseline, Day 6 (24 hours after the last suppository insertion)
Secondary outcomes (1)
Participant Perception of Vaginal Freshness and Odor
Evaluate participants' perceptions of the vaginal suppository's impact on vaginal freshness and odor, as well as the support of a calm, soothed, and balanced vaginal environment. This outcome measure is assessed with questionnaires.
Measured: Baseline, Day 2, Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start10 May 2024
- Primary completion10 Jul 2024
- Study completion10 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
- NCT06565312
- Sponsor's protocol ID
- 20434
- Status last verified
- Aug 2024
- First submitted
- 11 Jul 2024
- Last updated
- 21 Aug 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 21 Aug 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 Probiotic Vaginal Suppository on Vaginal Health.
- ClinicalTrials.gov ID
- NCT06565312
- Acronym / sponsor ID
- 20434
- Conditions
- Vaginal Health, Vaginal pH
- Keywords
- Vaginal suppository, Women's Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Love WellnessIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 10 May 2024 (actual)
- Primary completion
- 10 Jul 2024 (actual)
- Study completion
- 10 Jul 2024 (actual)
- First posted
- 21 Aug 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 lasting 8 weeks to evaluate the effects of a probiotic vaginal suppository on vaginal health. Participants will use the Flora Power suppository daily for 5 consecutive days when experiencing common signs of vaginal imbalance. They will complete questionnaires and vaginal pH tests before and after product use.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Flora Power Probiotic Vaginal Suppository | Experimental | Dietary Supplement: Flora Power Probiotic Vaginal SuppositoryParticipants will use the Flora Power suppository once daily at bedtime for 5 consecutive days when they feel they are experiencing any of the common signs of vaginal imbalance like vaginal malodor, vaginal irritation, and/or vaginal itching. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female at birth, aged 18+.
- Interested in maintaining a healthy vaginal environment.
- Experience common signs of vaginal imbalance (e.g., malodor, irritation).
- Willing to avoid other vaginal products and follow study protocol.
Key exclusion criteria (7 listed)
- Recent surgeries or invasive treatments.
- Use of vaginal health products in the last 12 weeks.
- Allergies to product ingredients.
- 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 |
|---|---|---|
| Flora Power Probiotic Vaginal SuppositoryThe suppository contains Microcrystalline Cellulose, Ascorbic Acid, Vitamin C, Gelatin Capsule, Vaginal Probiotic Blend (Lactobacillus fermentum LF61, Lactobacillus acidophilus LA85, Lactobacillus plantarum Lp90), Magnesium Stearate, and Silicon Dioxide. | Dietary supplement | Flora Power Probiotic Vaginal Suppository |
Primary outcome
Effect on Vaginal pH and Health
Time frame: Baseline, Day 6 (24 hours after the last suppository insertion)
Measure the change in vaginal pH levels with a test strip from baseline to 24 hours after the 5-day intervention period.
Effect on Vaginal pH and Health
Time frame: Baseline, Day 6 (24 hours after the last suppository insertion)
Measure the change in overall vaginal health from baseline to 24 hours after the 5-day intervention period with a questionnaire.
1 secondary outcome
Participant Perception of Vaginal Freshness and Odor
Time frame: Baseline, Day 2, Day 5
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 21 Aug 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 Flora Power Probiotic Vaginal Suppository in people with Vaginal Health and Vaginal pH, 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 4 inclusion and 7 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 21 Aug 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?
Effect on Vaginal pH and Health (time frame: Baseline, Day 6 (24 hours after the last suppository insertion)). 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 21 Aug 2024.