Trial Outcomes & Findings for A Comparison Study of Pain Relief From Dysmenorrhea Between the Vipon Tampon and Ibuprofen (NCT NCT00951561)
NCT ID: NCT00951561
Last Updated: 2011-06-16
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
115 participants
Primary outcome timeframe
1 month, 2 months, 3 months, 4 months
Results posted on
2011-06-16
Participant Flow
Participant milestones
| Measure |
Vipon/Ibuprofen/Vipon/Ibuprofen
Subjects participated for a total of 4 menstrual cycles. Subjects used either VIPON as a medical device or up to 2 ibuprofen tablets (each tablet containing 200 mg ibuprofen) during the first menstrual cycle. Subjects used crossover treatment during second menstrual cycle, randomized for cycle 3, and crossed over for cycle 4. All subjects used tampons for absorption of menstrual fluid during treatment and at least 2 hours post treatment. Subjects taking ibuprofen also used a tampon during treatment.
|
Ibuprofen/Vipon/Ibuprofen/Vipon
|
Vipon/Ibuprofen/Ibuprofen/Vipon
|
Ibuprofen/Vipon/Vipon/Ibuprofen
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
25
|
29
|
21
|
27
|
|
Overall Study
COMPLETED
|
25
|
29
|
18
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Comparison Study of Pain Relief From Dysmenorrhea Between the Vipon Tampon and Ibuprofen
Baseline characteristics by cohort
| Measure |
Study Participants
n=102 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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
102 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age Continuous
|
32.1 years
STANDARD_DEVIATION 8.1 • n=99 Participants
|
|
Sex: Female, Male
Female
|
102 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
102 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 1 month, 2 months, 3 months, 4 monthsPopulation: Statistical analysis was carried out per plan.
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.
Outcome measures
| Measure |
VIPON
n=191 uses of intervention
Subjects completed 4 treatment intervals; each subject was randomized to use the VIPON as their treatment during two intervals and Ibuprofen as their treatment during two intervals.
|
Ibuprofen
n=192 uses of intervention
Subjects completed 4 treatment intervals; each subject was randomized to use the VIPON as their treatment during two intervals and Ibuprofen as their treatment during two intervals.
|
|---|---|---|
|
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
|
75.5 percentage of uses
|
Adverse Events
Study Participants
Serious events: 2 serious events
Other events: 48 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Study Participants
n=102 participants at risk
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.
|
|---|---|
|
Reproductive system and breast disorders
Pregnancy
|
0.98%
1/102 • Number of events 1
No Serious Adverse Events were deemed to be related to the VIPON.
|
|
Gastrointestinal disorders
Appendicitis
|
0.98%
1/102 • Number of events 1
No Serious Adverse Events were deemed to be related to the VIPON.
|
Other adverse events
| Measure |
Study Participants
n=102 participants at risk
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.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Acne
|
0.98%
1/102 • Number of events 1
No Serious Adverse Events were deemed to be related to the VIPON.
|
|
Blood and lymphatic system disorders
Anemia
|
0.98%
1/102 • Number of events 1
No Serious Adverse Events were deemed to be related to the VIPON.
|
|
Psychiatric disorders
Anxiety
|
0.98%
1/102 • Number of events 2
No Serious Adverse Events were deemed to be related to the VIPON.
|
|
Musculoskeletal and connective tissue disorders
Back ache
|
2.0%
2/102 • Number of events 2
No Serious Adverse Events were deemed to be related to the VIPON.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
2.9%
3/102 • Number of events 3
No Serious Adverse Events were deemed to be related to the VIPON.
|
|
Infections and infestations
Cellulitis
|
0.98%
1/102 • Number of events 2
No Serious Adverse Events were deemed to be related to the VIPON.
|
|
Respiratory, thoracic and mediastinal disorders
Chest congestion
|
0.98%
1/102 • Number of events 1
No Serious Adverse Events were deemed to be related to the VIPON.
|
|
General disorders
Chest pain
|
0.98%
1/102 • Number of events 1
No Serious Adverse Events were deemed to be related to the VIPON.
|
|
General disorders
Chills
|
0.98%
1/102 • Number of events 1
No Serious Adverse Events were deemed to be related to the VIPON.
|
|
General disorders
Cold
|
0.98%
1/102 • Number of events 1
No Serious Adverse Events were deemed to be related to the VIPON.
|
|
Reproductive system and breast disorders
Colposcopy
|
0.98%
1/102 • Number of events 1
No Serious Adverse Events were deemed to be related to the VIPON.
|
|
General disorders
Cough
|
0.98%
1/102 • Number of events 1
No Serious Adverse Events were deemed to be related to the VIPON.
|
|
Reproductive system and breast disorders
Cramps
|
2.0%
2/102 • Number of events 2
No Serious Adverse Events were deemed to be related to the VIPON.
|
|
Infections and infestations
Cryptosporidiosis
|
0.98%
1/102 • Number of events 1
No Serious Adverse Events were deemed to be related to the VIPON.
|
|
General disorders
Daytime hypersomnia
|
0.98%
1/102 • Number of events 1
No Serious Adverse Events were deemed to be related to the VIPON.
|
|
General disorders
Decreased appetite
|
0.98%
1/102 • Number of events 1
No Serious Adverse Events were deemed to be related to the VIPON.
|
|
General disorders
Dental abscess
|
0.98%
1/102 • Number of events 1
No Serious Adverse Events were deemed to be related to the VIPON.
|
|
Infections and infestations
Dental infection
|
0.98%
1/102 • Number of events 1
No Serious Adverse Events were deemed to be related to the VIPON.
|
|
General disorders
Dental pain
|
2.0%
2/102 • Number of events 2
No Serious Adverse Events were deemed to be related to the VIPON.
|
|
Psychiatric disorders
Depression
|
0.98%
1/102 • Number of events 1
No Serious Adverse Events were deemed to be related to the VIPON.
|
|
Gastrointestinal disorders
Diarrhea
|
0.98%
1/102 • Number of events 1
No Serious Adverse Events were deemed to be related to the VIPON.
|
|
Cardiac disorders
Elevated blood pressure
|
2.0%
2/102 • Number of events 2
No Serious Adverse Events were deemed to be related to the VIPON.
|
|
General disorders
Fatigue
|
0.98%
1/102 • Number of events 1
No Serious Adverse Events were deemed to be related to the VIPON.
|
|
General disorders
Generalized body aches
|
0.98%
1/102 • Number of events 1
No Serious Adverse Events were deemed to be related to the VIPON.
|
|
Infections and infestations
Giardia
|
0.98%
1/102 • Number of events 1
No Serious Adverse Events were deemed to be related to the VIPON.
|
|
General disorders
Headache
|
9.8%
10/102 • Number of events 15
No Serious Adverse Events were deemed to be related to the VIPON.
|
|
General disorders
Hypercholesterolemia
|
0.98%
1/102 • Number of events 1
No Serious Adverse Events were deemed to be related to the VIPON.
|
|
Cardiac disorders
Hypertension
|
0.98%
1/102 • Number of events 1
No Serious Adverse Events were deemed to be related to the VIPON.
|
|
General disorders
Insect bite
|
0.98%
1/102 • Number of events 2
No Serious Adverse Events were deemed to be related to the VIPON.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.98%
1/102 • Number of events 1
No Serious Adverse Events were deemed to be related to the VIPON.
|
|
Immune system disorders
Lymphedema
|
0.98%
1/102 • Number of events 1
No Serious Adverse Events were deemed to be related to the VIPON.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.98%
1/102 • Number of events 1
No Serious Adverse Events were deemed to be related to the VIPON.
|
|
General disorders
Mountain sickness
|
0.98%
1/102 • Number of events 1
No Serious Adverse Events were deemed to be related to the VIPON.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.98%
1/102 • Number of events 2
No Serious Adverse Events were deemed to be related to the VIPON.
|
|
Cardiac disorders
Pericarditis
|
0.98%
1/102 • Number of events 1
No Serious Adverse Events were deemed to be related to the VIPON.
|
|
Surgical and medical procedures
Peridontal surgery
|
0.98%
1/102 • Number of events 1
No Serious Adverse Events were deemed to be related to the VIPON.
|
|
Infections and infestations
Poison ivy reaction
|
0.98%
1/102 • Number of events 1
No Serious Adverse Events were deemed to be related to the VIPON.
|
|
Infections and infestations
Rash
|
0.98%
1/102 • Number of events 1
No Serious Adverse Events were deemed to be related to the VIPON.
|
|
Gastrointestinal disorders
Rectal bleeding
|
0.98%
1/102 • Number of events 1
No Serious Adverse Events were deemed to be related to the VIPON.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory infection
|
0.98%
1/102 • Number of events 1
No Serious Adverse Events were deemed to be related to the VIPON.
|
|
Musculoskeletal and connective tissue disorders
Achilles tendon pain
|
0.98%
1/102 • Number of events 1
No Serious Adverse Events were deemed to be related to the VIPON.
|
|
Musculoskeletal and connective tissue disorders
Ankle pain
|
0.98%
1/102 • Number of events 1
No Serious Adverse Events were deemed to be related to the VIPON.
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
2.0%
2/102 • Number of events 4
No Serious Adverse Events were deemed to be related to the VIPON.
|
|
Surgical and medical procedures
Labial biopsy
|
0.98%
1/102 • Number of events 1
No Serious Adverse Events were deemed to be related to the VIPON.
|
|
General disorders
Root canal
|
0.98%
1/102 • Number of events 1
No Serious Adverse Events were deemed to be related to the VIPON.
|
|
Infections and infestations
Cyst
|
0.98%
1/102 • Number of events 1
No Serious Adverse Events were deemed to be related to the VIPON.
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
0.98%
1/102 • Number of events 1
No Serious Adverse Events were deemed to be related to the VIPON.
|
|
Infections and infestations
Sinus infection
|
5.9%
6/102 • Number of events 8
No Serious Adverse Events were deemed to be related to the VIPON.
|
|
General disorders
Stomach flu
|
0.98%
1/102 • Number of events 1
No Serious Adverse Events were deemed to be related to the VIPON.
|
|
Gastrointestinal disorders
Stomach pain
|
0.98%
1/102 • Number of events 1
No Serious Adverse Events were deemed to be related to the VIPON.
|
|
Infections and infestations
Strep throat
|
2.9%
3/102 • Number of events 3
No Serious Adverse Events were deemed to be related to the VIPON.
|
|
Skin and subcutaneous tissue disorders
Sunburn
|
0.98%
1/102 • Number of events 1
No Serious Adverse Events were deemed to be related to the VIPON.
|
|
General disorders
Swollen bruised right eye
|
0.98%
1/102 • Number of events 1
No Serious Adverse Events were deemed to be related to the VIPON.
|
|
General disorders
Tick bite
|
0.98%
1/102 • Number of events 2
No Serious Adverse Events were deemed to be related to the VIPON.
|
|
Musculoskeletal and connective tissue disorders
Twisted back
|
0.98%
1/102 • Number of events 1
No Serious Adverse Events were deemed to be related to the VIPON.
|
|
Infections and infestations
Upper respiratory infection
|
6.9%
7/102 • Number of events 7
No Serious Adverse Events were deemed to be related to the VIPON.
|
|
Infections and infestations
Urinary tract infection
|
0.98%
1/102 • Number of events 1
No Serious Adverse Events were deemed to be related to the VIPON.
|
|
Infections and infestations
Vaginal yeast infection
|
2.9%
3/102 • Number of events 4
No Serious Adverse Events were deemed to be related to the VIPON.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PI agrees not to originate or use the name of Another Way Products, LLC and/or VIPON, or any of its employees, in any publicity, news release or other public announcement, written or oral, whether to the public, press or otherwise, relating to this protocol, to any amendment herto, or to the performance here under, without the prior written consent of Another Way Products, LLC
- Publication restrictions are in place
Restriction type: OTHER