A Comparison Study of Pain Relief From Dysmenorrhea Between the Vipon Tampon and Ibuprofen

• Sponsor: Another Way Products (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00951561
• Collaborator: (none)
• Enrollment: 115
• Locations: 2
• Arms: 2
• Duration (Months): 34
• Patients Per Site: 57.5
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dysmenorrhea	Device: Vipon; Drug: Ibuprofen	N/A

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

• Study Type: Interventional
• Actual Enrollment: 115 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized Four-Way Crossover Comparison Study of Pain Relief From Dysmenorrhea Between the Vipon Tampon and Ibuprofen
• Study Start Date: Nov 1, 2006
• Actual Primary Completion Date: Sep 1, 2009
• Actual Study Completion Date: Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vipon	Device: Vipon; 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.; Other Names: Vipon, vibrating tampon
Active Comparator: Ibuprofen	Drug: Ibuprofen; 400 mg daily; Other Names: Ibuprofen, NSAIDs

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Truman Medical Center	Kansas City	Missouri	United States	64108
2	University of Kansas Medical Center, Department of Obstetrics and Gynecology	Kansas City	Missouri	United States	66160

Sponsors and Collaborators

• Another Way Products

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00951561
• Other Study ID Numbers: AWP01-01; NCT00456079; NCT00587782
• First Posted: Aug 4, 2009
• Last Update Posted: Jun 16, 2011
• Last Verified: Jun 1, 2011

• Keywords provided by , ,: Dysmenorrhea
• Additional relevant MeSH terms: Dysmenorrhea; Ibuprofen

Study Results

Participant Flow

Arm/Group Title	Vipon/Ibuprofen/Vipon/Ibuprofen	Ibuprofen/Vipon/Ibuprofen/Vipon	Vipon/Ibuprofen/Ibuprofen/Vipon	Ibuprofen/Vipon/Vipon/Ibuprofen
Arm/Group Description	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.
Period Title: Overall Study
STARTED	25	29	21	27
COMPLETED	25	29	18	26
NOT COMPLETED	0	0	3	1

Baseline Characteristics

Arm/Group Title	Study Participants
Arm/Group Description	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.
Overall Participants	102
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	102 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	32.1 (8.1)
Sex: Female, Male (Count of Participants)
Female	102 100%
Male	0 0%
Region of Enrollment (participants) [Number]
United States	102 100%

Outcome Measures

1. Primary Outcome

Title	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
Description	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

Outcome Measure Data

Analysis Population Description

Statistical analysis was carried out per plan.

Arm/Group Title	VIPON	Ibuprofen
Arm/Group Description	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.	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.
Measure Participants	98	98
Measure uses of intervention	191	192
Number [percentage of uses]	73.8	75.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	VIPON, Ibuprofen
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	The sample size calculation is performed in nQuery version 5.0 with the following stipulations: alpha is 0.05; response for both ibuprofen and Vipon is 85%; delta is 10%; no difference in response rates is expected between the two treatment arms, and power is 80%. This calculation is performed for an equivalence/non-inferiority primary analysis.
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in % of Uses from Mixed Model
	Estimated Value	-1.6
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Adverse Event Reporting Description	No Serious Adverse Events were deemed to be related to the VIPON.
Arm/Group Title	Study Participants
Arm/Group Description	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.
All Cause Mortality
	Study Participants
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Study Participants
	Affected / at Risk (%)	# Events
Total	2/102 (2%)
Gastrointestinal disorders
Appendicitis	1/102 (1%)	1
Reproductive system and breast disorders
Pregnancy	1/102 (1%)	1
Other (Not Including Serious) Adverse Events
	Study Participants
	Affected / at Risk (%)	# Events
Total	48/102 (47.1%)
Blood and lymphatic system disorders
Anemia	1/102 (1%)	1
Cardiac disorders
Elevated blood pressure	2/102 (2%)	2
Hypertension	1/102 (1%)	1
Pericarditis	1/102 (1%)	1
Gastrointestinal disorders
Diarrhea	1/102 (1%)	1
Rectal bleeding	1/102 (1%)	1
Stomach pain	1/102 (1%)	1
General disorders
Chest pain	1/102 (1%)	1
Chills	1/102 (1%)	1
Cold	1/102 (1%)	1
Cough	1/102 (1%)	1
Daytime hypersomnia	1/102 (1%)	1
Decreased appetite	1/102 (1%)	1
Dental abscess	1/102 (1%)	1
Dental pain	2/102 (2%)	2
Fatigue	1/102 (1%)	1
Generalized body aches	1/102 (1%)	1
Headache	10/102 (9.8%)	15
Hypercholesterolemia	1/102 (1%)	1
Insect bite	1/102 (1%)	2
Mountain sickness	1/102 (1%)	1
Root canal	1/102 (1%)	1
Stomach flu	1/102 (1%)	1
Swollen bruised right eye	1/102 (1%)	1
Tick bite	1/102 (1%)	2
Immune system disorders
Lymphedema	1/102 (1%)	1
Infections and infestations
Cellulitis	1/102 (1%)	2
Cryptosporidiosis	1/102 (1%)	1
Dental infection	1/102 (1%)	1
Giardia	1/102 (1%)	1
Poison ivy reaction	1/102 (1%)	1
Rash	1/102 (1%)	1
Cyst	1/102 (1%)	1
Sinus infection	6/102 (5.9%)	8
Strep throat	3/102 (2.9%)	3
Upper respiratory infection	7/102 (6.9%)	7
Urinary tract infection	1/102 (1%)	1
Vaginal yeast infection	3/102 (2.9%)	4
Musculoskeletal and connective tissue disorders
Back ache	2/102 (2%)	2
Joint swelling	1/102 (1%)	1
Neck pain	1/102 (1%)	2
Achilles tendon pain	1/102 (1%)	1
Ankle pain	1/102 (1%)	1
Knee pain	2/102 (2%)	4
Shoulder pain	1/102 (1%)	1
Twisted back	1/102 (1%)	1
Psychiatric disorders
Anxiety	1/102 (1%)	2
Depression	1/102 (1%)	1
Reproductive system and breast disorders
Colposcopy	1/102 (1%)	1
Cramps	2/102 (2%)	2
Menorrhagia	1/102 (1%)	1
Respiratory, thoracic and mediastinal disorders
Bronchitis	3/102 (2.9%)	3
Chest congestion	1/102 (1%)	1
Respiratory infection	1/102 (1%)	1
Skin and subcutaneous tissue disorders
Acne	1/102 (1%)	1
Sunburn	1/102 (1%)	1
Surgical and medical procedures
Peridontal surgery	1/102 (1%)	1
Labial biopsy	1/102 (1%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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