A Feasibility Study Designed to Assess the Efficacy of the ActiLady Device in Adult Female Subjects With Dysmenorrhea
NCT ID: NCT00855829
Last Updated: 2013-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2010-05-31
2013-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Miniature Actilady device active
one miniature Actilady device tested for all patients during a 4 months period. The device is active in 3 months out of the 4, and the patients are blinded to the action of the device (sham comparator).
Miniature Actilady device active
Devices: Targeted pressure waves are created by two kind of methods ActiLady).
1. The effect of the waves used will be examined by the use of a silicon tube or polyvinyl chloride (PVC) tube which is inserted into the vaginal cavity. The other end of the tube will be connected to an "off the shelf" pressure waves generator and controller.
2. Self manufactured device inserted into the vaginal cavity and creating subsound pressure waves.
Miniature Actilady device not active
Sham Comparator: one miniature Actilady device tested for all patients during a 4 months period. The device is active in 3 months out of the 4, and the patients are blinded to the action of the device (sham comparator).
Miniature Actilady device not active
Devices: Targeted pressure waves are created by two kind of methods ActiLady).
The effect of the waves used will be examined by the use of a silicon tube or polyvinyl chloride (PVC) tube which is inserted into the vaginal cavity. The other end of the tube will be connected to an "off the shelf" pressure waves generator and controller.
Self manufactured device inserted into the vaginal cavity and creating subsound pressure waves.
Interventions
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Miniature Actilady device active
Devices: Targeted pressure waves are created by two kind of methods ActiLady).
1. The effect of the waves used will be examined by the use of a silicon tube or polyvinyl chloride (PVC) tube which is inserted into the vaginal cavity. The other end of the tube will be connected to an "off the shelf" pressure waves generator and controller.
2. Self manufactured device inserted into the vaginal cavity and creating subsound pressure waves.
Miniature Actilady device not active
Devices: Targeted pressure waves are created by two kind of methods ActiLady).
The effect of the waves used will be examined by the use of a silicon tube or polyvinyl chloride (PVC) tube which is inserted into the vaginal cavity. The other end of the tube will be connected to an "off the shelf" pressure waves generator and controller.
Self manufactured device inserted into the vaginal cavity and creating subsound pressure waves.
Eligibility Criteria
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Inclusion Criteria
2. Regular menstrual cycles (26-35 days); average duration of menstruation ≥5 days for the 4 months preceding the beginning of the trial.
3. Dysmenorrhea pain score \>50mm on a 100mm visual analog scale (VAS) for the maximum abdominal pain
4. Analgesic use during every menstrual cycle
5. Non-pregnant, with no intentions to get pregnant during the clinical trial
6. Agrees not to use oral contraceptives or an intrauterine device (IUD) during the trial period
7. Agrees not to use analgesics, except during permitted period (16:00-04:00 the next day, daily)
8. Consents to the use of pads or other vaginal devices throughout the trial period
9. Subject is able to comply with all the requirements of the study and agrees to participate in all the activities of the study
10. Signed written informed consent form (ICF) to participate in the study
Exclusion Criteria
2. Used hormonal and/or oral contraceptives in the preceding 4 months
3. Use of an IUD in the preceding 4 months
4. Previous diagnosis of secondary dysmenorrhea
5. Urinary incontinence
6. Duration of menstruation is \<5 days
7. Subjects with a known sensitivity to mechanical vibrations and/or silicone
8. Participation in current or recent clinical trial within 30 days prior to baseline visit
18 Years
35 Years
FEMALE
No
Sponsors
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Hadassah Medical Organization
OTHER
Responsible Party
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Ezra Yosi
Prof. Yossi Ezra
Locations
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Hadassah Medical Center
Jerusalem, , Israel
Hadassah Medical Organization
Jerusalem, , Israel
Countries
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Other Identifiers
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galmedics-HMO-CTIL
Identifier Type: -
Identifier Source: org_study_id