Vaginal HealthNCT06506357
A Single Group Study to Evaluate the Effects of a Probiotic Supplement on Vaginal Health.
A study testing Good Girl Probiotics in people with Vaginal Health and Women's Health, run by Love Wellness at 1 site in United States.
Trial summary
This virtual single-group clinical trial aims to evaluate the effects of the Good Girl Probiotics supplement on vaginal health. Participants will take one capsule of the probiotic supplement daily for eight weeks. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vaginal Health, Women's Health
- What is being tested?
- Good Girl Probiotics
- 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
- 24 Apr 2024to 24 Jun 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 supporting a balanced vaginal pH, vaginal health, and urinary tract health.
- Regularly experience symptoms of an unbalanced vagina, including an atypical smell, discharge, itching, swelling, irritation, pain during sex, and/or burning sensation while urinating.
- Willing to avoid using products or medications that target vaginal or urinary tract health infections.
- Willing to avoid other probiotics.
- Able to follow the study protocol.
Who cannot join
- Two or more bladder infections in six months or three or more infections in a year.
- Recent surgeries or invasive treatments within the last six months.
- Use of products or medications targeting vaginal or urinary tract health in the last 12 weeks.
- Known allergies to the product ingredients.
- Chronic health conditions impacting participation.
- Pregnant, breastfeeding, or trying to conceive.
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- History of substance abuse.
- Current or former smoker within the past six months.
- Participation in another clinical trial.
- Diagnosed vaginal or pelvic conditions.
- Use of vaginal-related birth control (NuvaRing, IUD).
- Changes in hormonal birth control in the last three months.
Trial locations and contacts
1 site in 1 country.
About this study
This virtual single-group clinical trial aims to evaluate the effects of the Good Girl Probiotics supplement on vaginal health. Participants will take one capsule of the probiotic supplement daily for eight weeks. They will complete questionnaires at Baseline, after the first dose, and at the end of Weeks 2, 4, 6, and 8 to assess changes in vaginal pH, vaginal health, and urinary tract health.
- Conditions
- Vaginal Health, Women's Health
- Being tested
- Good Girl Probiotics
- Keywords
- Probiotic Supplement, Urinary Tract Health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Good Girl ProbioticsDietary supplement
Participants will take one capsule of the Good Girl Probiotics supplement daily in the morning for eight weeks.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic Supplement Group | Experimental | Participants in this group will receive the Good Girl Probiotics supplement. Receives: Dietary Supplement: Good Girl Probiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal and Urinary Tract Health and Balance
Assessment of vaginal and urinary tract health and balance through questionnaires completed by participants at Baseline, after the first dose, and at the end of Weeks 2, 4, 6, and 8.
Measured: Baseline, Week 2, Week 4, Week 6, Week 8
Secondary outcomes (1)
Vaginal Environment and Odor
Assessment of the vaginal environment and odor through questionnaires completed by participants at Baseline, after the first dose, and at the end of Weeks 2, 4, 6, and 8.
Measured: Baseline, Week 2, Week 4, Week 6, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start24 Apr 2024
- Primary completion24 Jun 2024
- Study completion24 Jun 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
- Treatment
- 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
- NCT06506357
- Sponsor's protocol ID
- 20433
- Status last verified
- Jul 2024
- First submitted
- 11 Jul 2024
- Last updated
- 17 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 17 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 Probiotic Supplement on Vaginal Health.
- ClinicalTrials.gov ID
- NCT06506357
- Acronym / sponsor ID
- 20433
- Conditions
- Vaginal Health, Women's Health
- Keywords
- Probiotic Supplement, Urinary Tract Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Love WellnessIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 24 Apr 2024 (actual)
- Primary completion
- 24 Jun 2024 (actual)
- Study completion
- 24 Jun 2024 (actual)
- First posted
- 17 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 virtual single-group clinical trial aims to evaluate the effects of the Good Girl Probiotics supplement on vaginal health. Participants will take one capsule of the probiotic supplement daily for eight weeks. They will complete questionnaires at Baseline, after the first dose, and at the end of Weeks 2, 4, 6, and 8 to assess changes in vaginal pH, vaginal health, and urinary tract health.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Probiotic Supplement Group | Experimental | Dietary Supplement: Good Girl ProbioticsParticipants in this group will receive the Good Girl Probiotics supplement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female at birth.
- Aged 18+.
- Interested in supporting a balanced vaginal pH, vaginal health, and urinary tract health.
- Regularly experience symptoms of an unbalanced vagina, including an atypical smell, discharge, itching, swelling, irritation, pain during sex, and/or burning sensation while urinating.
- Willing to avoid using products or medications that target vaginal or urinary tract health infections.
Key exclusion criteria (12 listed)
- Two or more bladder infections in six months or three or more infections in a year.
- Recent surgeries or invasive treatments within the last six months.
- Use of products or medications targeting vaginal or urinary tract health in the last 12 weeks.
- Known allergies to the product ingredients.
- Chronic health conditions impacting participation.
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 |
|---|---|---|
| Good Girl ProbioticsParticipants will take one capsule of the Good Girl Probiotics supplement daily in the morning for eight weeks. | Dietary supplement | Probiotic Supplement Group |
Primary outcome
Vaginal and Urinary Tract Health and Balance
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8
Assessment of vaginal and urinary tract health and balance through questionnaires completed by participants at Baseline, after the first dose, and at the end of Weeks 2, 4, 6, and 8.
1 secondary outcome
Vaginal Environment and Odor
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8
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 17 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 Good Girl Probiotics in people with Vaginal Health and Women's Health, 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 7 inclusion and 12 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 17 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 and Urinary Tract Health and Balance (time frame: Baseline, Week 2, Week 4, Week 6, Week 8). 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 17 Jul 2024.