DysmenorrheaNCT00951561
A Comparison Study of Pain Relief From Dysmenorrhea Between the Vipon Tampon and Ibuprofen
A study testing Vipon and Ibuprofen in people with Dysmenorrhea, run by Another Way Products at 2 sites in United States.
Trial summary
The purpose of this study is to compare the Vipon tampon with ibuprofen in relieving pain in women with dysmenorrhea. Subjects completed a total of 4 treatment intervals; each subject was randomized to use the VIPON as their treatment for two intervals and Ibuprofen as their treatment for two intervals. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dysmenorrhea
- What is being tested?
- Vipon and Ibuprofen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2006to Sep 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Females ages >= 18 years
- 4 consecutive monthly menstrual cycles
- Self-assessment of dysmenorrhea
- Non-pregnant status
- Agrees to use adequate birth control during the trial
- Consents to use tampons through the test of cure assessment
- Provides informed consent for participating in the trial
Who cannot join
- Prohibited use of pain medication 4 hours prior to treatment and during the first 2 hours after treatment with study medication
- Positive pregnancy test
- Unwilling or unable to comply with protocol
- Allergic to ibuprofen
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Truman Medical Center
Kansas City, Missouri, 64108
University of Kansas Medical Center, Department of Obstetrics and Gynecology
Kansas City, Missouri, 66160
About this study
Official title: A Randomized Four-Way Crossover Comparison Study of Pain Relief From Dysmenorrhea Between the Vipon Tampon and Ibuprofen
The purpose of this study is to compare the Vipon tampon with ibuprofen in relieving pain in women with dysmenorrhea. Subjects completed a total of 4 treatment intervals; each subject was randomized to use the VIPON as their treatment for two intervals and Ibuprofen as their treatment for two intervals.
Read the detailed description
Pain caused by dysmenorrhea can range from mild to severe. At least 50% of all menstruating women experience appreciable pain at some time during their menstruation. An estimated 600 million work hours are lost annually to this affliction with an average loss of time of two or more workdays per year per female employee. Treatment of dysmenorrhea may include either non-pharmacological or pharmacological measures. Pharmacological treatments include oral contraceptives to treat hormonal imbalances, over-the-counter analgesics or non-steroidal anti-inflammatory drugs. The Vipon is a tampon with a small motor unit within, which produces vibratory stimulation. This study aims to provide information on the safety and efficacy of the Vipon in a randomized controlled clinical trial.
- Conditions
- Dysmenorrhea
- Being tested
- Vipon, Ibuprofen
- Keywords
- Dysmenorrhea
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ViponDevice
Also called Vipon, vibrating tampon
The Vipon is a tampon with a small motor unit within, which produces vibratory stimulation, used during menstruation to provide pain relief for women with dysmenorrhea.
IbuprofenDrug
Also called Ibuprofen, NSAIDs
400 mg daily
| Study group | Role | What they receive |
|---|---|---|
| Vipon | Experimental | Not described Receives: Device: Vipon |
| Ibuprofen | Active comparator | Not described Receives: Drug: Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Intervention Uses That Resulted in at Least 1 Point Decrease in Pain and Requiring no Rescue Medication Using the Modified Melzack-McGill Scale Using a Mixed Model
Modified Melzack-McGill Scale measures general pain (0=none, 1-3=mild, 4-6=moderate, 7-9=severe, 10=worst pain) Total Number of Uses Analyzed is a sum of the Number of Uses collected at each time point.
Measured: 1 month, 2 months, 3 months, 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2009 (estimated)
- Study startNov 2006
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DysmenorrheaStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Another Way Products
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00951561
- Sponsor's protocol ID
- AWP01-01
- Status last verified
- Jun 2011
- First submitted
- 31 Jul 2009
- Last updated
- 16 Jun 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Four-Way Crossover Comparison Study of Pain Relief From Dysmenorrhea Between the Vipon Tampon and Ibuprofen
- ClinicalTrials.gov ID
- NCT00951561
- Acronym / sponsor ID
- AWP01-01
- Conditions
- Dysmenorrhea
- Keywords
- Dysmenorrhea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Another Way ProductsIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 4 Aug 2009 (estimated)
- Results
- Posted 4 Oct 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the Vipon tampon with ibuprofen in relieving pain in women with dysmenorrhea. Subjects completed a total of 4 treatment intervals; each subject was randomized to use the VIPON as their treatment for two intervals and Ibuprofen as their treatment for two intervals.
Detailed description
Pain caused by dysmenorrhea can range from mild to severe. At least 50% of all menstruating women experience appreciable pain at some time during their menstruation. An estimated 600 million work hours are lost annually to this affliction with an average loss of time of two or more workdays per year per female employee. Treatment of dysmenorrhea may include either non-pharmacological or pharmacological measures. Pharmacological treatments include oral contraceptives to treat hormonal imbalances, over-the-counter analgesics or non-steroidal anti-inflammatory drugs. The Vipon is a tampon with a small motor unit within, which produces vibratory stimulation. This study aims to provide information on the safety and efficacy of the Vipon in a randomized controlled clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vipon | Experimental | Device: Vipon |
| Ibuprofen | Active comparator | Drug: Ibuprofen |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Females ages >= 18 years
- 4 consecutive monthly menstrual cycles
- Self-assessment of dysmenorrhea
- Non-pregnant status
- Agrees to use adequate birth control during the trial
Key exclusion criteria (4 listed)
- Prohibited use of pain medication 4 hours prior to treatment and during the first 2 hours after treatment with study medication
- Positive pregnancy test
- Unwilling or unable to comply with protocol
- Allergic to ibuprofen
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 |
|---|---|---|
| ViponAlso: Vipon, vibrating tamponThe Vipon is a tampon with a small motor unit within, which produces vibratory stimulation, used during menstruation to provide pain relief for women with dysmenorrhea. | Device | Vipon |
| IbuprofenAlso: Ibuprofen, NSAIDs400 mg daily | Drug | Ibuprofen |
Primary outcome
Percentage of Intervention Uses That Resulted in at Least 1 Point Decrease in Pain and Requiring no Rescue Medication Using the Modified Melzack-McGill Scale Using a Mixed Model
Time frame: 1 month, 2 months, 3 months, 4 months
Modified Melzack-McGill Scale measures general pain (0=none, 1-3=mild, 4-6=moderate, 7-9=severe, 10=worst pain) Total Number of Uses Analyzed is a sum of the Number of Uses collected at each time point.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vipon and Ibuprofen in people with Dysmenorrhea, run by Another Way Products at 2 sites 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 4 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 16 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 4 Oct 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Intervention Uses That Resulted in at Least 1 Point Decrease in Pain and Requiring no Rescue Medication Using the Modified Melzack-McGill Scale Using a Mixed Model (time frame: 1 month, 2 months, 3 months, 4 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 16 Jun 2011.