Safety IssuesNCT04268758
A Single-center Study Designed to Evaluate the Safety and Efficacy of Tulipon
An observational study of Safety Issues, run by Hadassah Medical Organization.
Trial summary
Subjects who normally use tampons will use Tulipon device during one menstrual cycle. Baseline and post usage clinical evaluation will be performed for safety testing. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Safety Issues
- What is being tested?
- tulipon
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2021to Dec 2021
- Phase
- Observational
- 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 to 45 years
- Women only
- Adult
Study population: Adult females with normal monthly menstruation.
Who may be able to join
- Women aged 18-45 years
- Regular menstrual cycles (21-35 days)
- Uses tampons every month for the last 2 months to handle their monthly bleeding.
- Active Bleeding lasts at least 3 days
- Willing not to change their feminine care or hygiene practices during their participation in the study (except as directed by the protocol and instructions for participants)
- Non-pregnant, with no intentions to get pregnant during the clinical trial
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- Willing to use pads provided thought the study only for the duration of this study
- Subject is able to comply with all the requirements of the study and agrees to participate in all the activities of the study
- Signed written informed consent form (ICF) to participate in the study
Who cannot join
- Pregnant or lactating women
- Gave birth less than a 12 month prior to the study.
- Virgin
- Using medications to manage pain during active bleeding
- Using intrauterine device or intrauterine device with hormones (Mirena)
- Had experienced Toxic shock syndrome (TSS)
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- Previous diagnosis of primary or secondary dysmenorrhea
- Previous diagnosis of endometriosis
- Experiences urinary incontinence
- Suffers from uterus or urine prolapse
- Abnormal findings following the gynecological exam
- Subjects with a known or suspected sensitivity to any of the device materials (Polyethylene, Polyurethane, Nylon, Cotton)
- Been through a vaginal operation in the last 6 months prior to the study.
- Participation in current or recent clinical trial within 30 days prior to baseline visit
About this study
Official title: A Single-center Study Designed to Evaluate the Safety and Efficacy of a New Hygienic Device, Tulipon, in Adult Females With Normal Monthly Menstruation
Subjects who normally use tampons will use Tulipon device during one menstrual cycle. Baseline and post usage clinical evaluation will be performed for safety testing.
Read the detailed description
Subjects use Tulipon device during one menstrual cycle. Baseline and post usage clinical evaluation will be performed for safety testing.
- Conditions
- Safety Issues
- Being tested
- tulipon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tuliponDevice
Tulipon is a new kind of hygienic device, used to collect the secreted menses during the bleeding phase of the menstruation.
What is being measured
The primary outcome is the main question the study is designed to answer.
safety and efficacy of the Tulipon.
We will take vaginal cultures to show no vaginal infection. By questionnaire we will find out about leakage of period blood from the Tulipon.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start1 Jun 2021 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Why it stopped: logistic and financial issues.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety IssuesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Collaborators
- Gals Bio Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04268758
- Sponsor's protocol ID
- Tulipon-HMO-CTIL
- Status last verified
- Apr 2020
- First submitted
- 10 Feb 2020
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center Study Designed to Evaluate the Safety and Efficacy of a New Hygienic Device, Tulipon, in Adult Females With Normal Monthly Menstruation
- ClinicalTrials.gov ID
- NCT04268758
- Acronym / sponsor ID
- Tulipon-HMO-CTIL
- Conditions
- Safety Issues
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: logistic and financial issues.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Collaborators
- Gals Bio Ltd.
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 13 Feb 2020 (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.
Subjects who normally use tampons will use Tulipon device during one menstrual cycle. Baseline and post usage clinical evaluation will be performed for safety testing.
Detailed description
Subjects use Tulipon device during one menstrual cycle. Baseline and post usage clinical evaluation will be performed for safety testing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Adult females with normal monthly menstruation.
Key inclusion criteria (9 listed)
- Women aged 18-45 years
- Regular menstrual cycles (21-35 days)
- Uses tampons every month for the last 2 months to handle their monthly bleeding.
- Active Bleeding lasts at least 3 days
- Willing not to change their feminine care or hygiene practices during their participation in the study (except as directed by the protocol and instructions for participants)
Key exclusion criteria (14 listed)
- Pregnant or lactating women
- Gave birth less than a 12 month prior to the study.
- Virgin
- Using medications to manage pain during active bleeding
- Using intrauterine device or intrauterine device with hormones (Mirena)
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 |
|---|---|---|
| tuliponTulipon is a new kind of hygienic device, used to collect the secreted menses during the bleeding phase of the menstruation. | Device | – |
Primary outcome
safety and efficacy of the Tulipon.
Time frame: 1 month
We will take vaginal cultures to show no vaginal infection. By questionnaire we will find out about leakage of period blood from the Tulipon.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
- Individual participant dataSharing planned: 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Safety Issues, run by Hadassah Medical Organization.
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: withdrawn, as of the sponsor's last update on 4 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
safety and efficacy of the Tulipon. (time frame: 1 month). 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 4 Aug 2022.