Safety and Tolerability in Healthy VolunteersNCT07807891
Safety and Tolerability of an Ultra Absorbency Menstrual Tampon Compared to a Commercially Marketed Tampon
A study testing Tampon in people with Safety and Tolerability in Healthy Volunteers, run by Lyv Life Inc. (dba: Cora) at 1 site in United States.
Trial summary
A Randomized, Open-Label, Evaluator-Blinded, Cross-Over Clinical Study to Confirm the Safety and Tolerability of an Ultra Absorbency Menstrual Tampon Compared to a Commercially Marketed Tampon Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Safety and Tolerability in Healthy Volunteers
- What is being tested?
- Tampon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2026to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female, 18-49, good general health, written informed consent Regular cycles ~21-35 days with ≥4 days menstruation; can predict onset within 72 hrs History of ultra/super-plus tampon use; normally uses ≥4 ultra (15-18 g) or super-plus (12-15 g) tampons/cycle Willing to use only provided products (tampons + liners + pads) and complete diary/returns Access to a freezer to store used tampons Normal Pap within 3 yrs (or normal Pap + negative HPV within 5 yrs) Acceptable birth control ≥1 month prior and through study Willing to undergo 4 gyn exams (speculum + colposcope) over 2 cycles
Who cannot join
- Uncontrolled chronic disease (e.g., IDDM, HIV/AIDS); active genital herpes in last 3 yrs Menstrual abnormality (oligomenorrhea/amenorrhea) Abnormal Pap in last 3 yrs / positive HPV in last 5 yrs / gyn cancer or disorder History of TSS in last year or PID in past year Allergy/sensitivity to tampon components or exam lubricant Pregnant, planning pregnancy, nursing/lactating, or <6 weeks post-partum Active vaginal infection, UTI, yeast infection, or hemorrhoids at exam Type B/C lesions, or Type A lesions covering >50% of a site, at baseline
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Princeton Consumer Research (PCR)
St. Petersburg, Florida, 33702
Chrissy Maraghy, (727) 576 7300, chrissy@princetonconsumer.com
Chrissy Maraghy
About this study
Official title: A Randomized, Open-label, Evaluator-Blinded, Cross-over Clinical Study to Confirm the Safety and Tolerability of an Ultra Absorbency Menstrual Tampon Compared to a Commercially Marketed Tampon
A Randomized, Open-Label, Evaluator-Blinded, Cross-Over Clinical Study to Confirm the Safety and Tolerability of an Ultra Absorbency Menstrual Tampon Compared to a Commercially Marketed Tampon
- Being tested
- Tampon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamponDevice
Commercially marketed comparator tampon used during the assigned menstrual cycle according to the protocol.
| Study group | Role | What they receive |
|---|---|---|
| Unibeauty organic cotton ultra absorbency tampon | Experimental | Not described Receives: Device: Tampon |
| Tampax Pearl | Active comparator | Not described Receives: Device: Tampon |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety of the Unibeauty ultra absorbency tampon relative to a commercially marketed ultra absorbency comparator tampon
To evaluate the safety of the Unibeauty ultra absorbency tampon relative to a commercially marketed ultra absorbency comparator tampon
Measured: 3 months
Secondary outcomes (1)
Adverse events - incidence, type, frequency, severity (mild/moderate/severe), seriousness (AE vs. SAE), device-relatedness, and outcome.
Adverse events - incidence, type, frequency, severity (mild/moderate/severe), seriousness (AE vs. SAE), device-relatedness, and outcome.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start10 Sep 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety and Tolerability in Healthy VolunteersStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lyv Life Inc. (dba: Cora)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07807891
- Sponsor's protocol ID
- CORCLI2F
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Evaluator-Blinded, Cross-over Clinical Study to Confirm the Safety and Tolerability of an Ultra Absorbency Menstrual Tampon Compared to a Commercially Marketed Tampon
- ClinicalTrials.gov ID
- NCT07807891
- Acronym / sponsor ID
- CORCLI2F
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Lyv Life Inc. (dba: Cora)Industry (pharma, biotech, devices)
- Study start
- 10 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 8 Sep 2026 (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.
A Randomized, Open-Label, Evaluator-Blinded, Cross-Over Clinical Study to Confirm the Safety and Tolerability of an Ultra Absorbency Menstrual Tampon Compared to a Commercially Marketed Tampon
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unibeauty organic cotton ultra absorbency tampon | Experimental | Device: Tampon |
| Tampax Pearl | Active comparator | Device: Tampon |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Female, 18-49, good general health, written informed consent Regular cycles ~21-35 days with ≥4 days menstruation; can predict onset within 72 hrs History of ultra/super-plus tampon use; normally uses ≥4 ultra (15-18 g) or super-plus (12-15 g) tampons/cycle Willing to use only provided products (tampons + liners + pads) and complete diary/returns Access to a freezer to store used tampons Normal Pap within 3 yrs (or normal Pap + negative HPV within 5 yrs) Acceptable birth control ≥1 month prior and through study Willing to undergo 4 gyn exams (speculum + colposcope) over 2 cycles
Key exclusion criteria (1 listed)
- Uncontrolled chronic disease (e.g., IDDM, HIV/AIDS); active genital herpes in last 3 yrs Menstrual abnormality (oligomenorrhea/amenorrhea) Abnormal Pap in last 3 yrs / positive HPV in last 5 yrs / gyn cancer or disorder History of TSS in last year or PID in past year Allergy/sensitivity to tampon components or exam lubricant Pregnant, planning pregnancy, nursing/lactating, or <6 weeks post-partum Active vaginal infection, UTI, yeast infection, or hemorrhoids at exam Type B/C lesions, or Type A lesions covering >50% of a site, at baseline
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 |
|---|---|---|
| TamponCommercially marketed comparator tampon used during the assigned menstrual cycle according to the protocol. | Device | Tampax Pearl, Unibeauty organic cotton ultra absorbency tampon |
Primary outcome
To evaluate the safety of the Unibeauty ultra absorbency tampon relative to a commercially marketed ultra absorbency comparator tampon
Time frame: 3 months
To evaluate the safety of the Unibeauty ultra absorbency tampon relative to a commercially marketed ultra absorbency comparator tampon
1 secondary outcome
Adverse events - incidence, type, frequency, severity (mild/moderate/severe), seriousness (AE vs. SAE), device-relatedness, and outcome.
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tampon in people with Safety and Tolerability in Healthy Volunteers, run by Lyv Life Inc. (dba: Cora) 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 8 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chrissy Maraghy ((727) 576 7300, chrissy@princetonconsumer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety of the Unibeauty ultra absorbency tampon relative to a commercially marketed ultra absorbency comparator tampon (time frame: 3 months). 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 8 Sep 2026.