A Feasibility Study Designed to Assess the Efficacy of the ActiLady Device in Adult Female Subjects With Dysmenorrhea

Study Overview
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Brief Summary
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ActiLady refers is employing targeted pressure waves, with the goal of reducing the pain associated with menstruation (clinically known as dysmenorrhea).

Official Title
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A Single-Center, Randomized, Controlled, Double-Blind Feasibility Study Designed to Assess the Safety Performance of ActiLady Prototype in Adult Female Subjects With Dysmenorrhea.

Conditions
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Dysmenorrhea

Intervention / Treatment
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* Device: Miniature Actilady device active
* Device: Miniature Actilady device not active


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women aged 18-35 years Regular menstrual cycles (26-35 days); average duration of menstruation ≥5 days for the 4 months preceding the beginning of the trial. Dysmenorrhea pain score >50mm on a 100mm visual analog scale (VAS) for the maximum abdominal pain Analgesic use during every menstrual cycle Non-pregnant, with no intentions to get pregnant during the clinical trial Agrees not to use oral contraceptives or an intrauterine device (IUD) during the trial period Agrees not to use analgesics, except during permitted period (16:00-04:00 the next day, daily) Consents to the use of pads or other vaginal devices throughout the trial period Subject is able to comply with all the requirements of the study and agrees to participate in all the activities of the study Signed written informed consent form (ICF) to participate in the study Exclusion Criteria: Pregnant or lactating women Used hormonal and/or oral contraceptives in the preceding 4 months Use of an IUD in the preceding 4 months Previous diagnosis of secondary dysmenorrhea Urinary incontinence Duration of menstruation is <5 days Subjects with a known sensitivity to mechanical vibrations and/or silicone Participation in current or recent clinical trial within 30 days prior to baseline visit

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Miniature Actilady device active<br>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). | Device: Miniature Actilady device active<br>* 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.<br>|
| Sham Comparator: Miniature Actilady device not active<br>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). | Device: Miniature Actilady device not active<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety of a novel method and device called ActiLady. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| * Evaluate the pain-reducing effect of ActiLady on dysmenorrhea. * Study the relationship between menses flux and dysmenorrhea. [Time Frame: 6 months] [Designated as safety issue: No ] * Optimize treatment procedure and wave form. |  | 6 months |