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

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

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

Study Overview

• Status: Completed
• Conditions: Dysmenorrhea
• Intervention / Treatment: Device: Miniature Actilady device active; Device: Miniature Actilady device not active

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel, 91120
    • Hadassah Medical Organization
  • Jerusalem, Israel, 91120
    • Hadassah Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Women aged 18-35 years
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:

1. Pregnant or lactating women
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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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).	Device: Miniature Actilady device 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.
SHAM_COMPARATOR: 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).	Device: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Hadassah Medical Organization

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (ACTUAL): May 1, 2013
• Study Completion (ACTUAL): October 1, 2013

Study Registration Dates

• First Submitted: March 3, 2009
• First Submitted That Met QC Criteria: March 3, 2009
• First Posted (ESTIMATE): March 4, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): November 13, 2013
• Last Update Submitted That Met QC Criteria: November 10, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Menstruation Disturbances; Pelvic Pain; Dysmenorrhea
• Other Study ID Numbers: galmedics-HMO-CTIL