Dysmenorrhea
Conditions
Keywords
Dysmenorrhea
Brief 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.
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.
Interventions
DEVICEVipon
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.
DRUGIbuprofen
400 mg daily
Sponsors
Another Way Products
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Study Participants 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. | 102 |
| Total | 102 |
Baseline characteristics
| Characteristic | Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 102 Participants |
| Age Continuous | 32.1 years STANDARD_DEVIATION 8.1 |
| Region of Enrollment United States | 102 participants |
| Sex: Female, Male Female | 102 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 48 / 102 |
| serious Total, serious adverse events | 2 / 102 |
Outcome results
Primary
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.
Time frame: 1 month, 2 months, 3 months, 4 months
Population: Statistical analysis was carried out per plan.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VIPON | 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 | 73.8 percentage of uses |
| Ibuprofen | 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 | 75.5 percentage of uses |
p-value: <0.05Mixed Models Analysis