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

NCT00855829 | Completed Phase 1

• 1 other identifier: galmedics-HMO-CTIL
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Dysmenorrhea

Outcome Measures

Primary Outcomes (1)

• To evaluate the safety of a novel method and device called ActiLady.

  6 months

Secondary Outcomes (1)

• * 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

Study Arms (2)

Miniature Actilady device active

ACTIVE 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 active

Miniature Actilady device not active

SHAM COMPARATOR

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

Interventions

Miniature Actilady device active DEVICE

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 active

Miniature Actilady device not active DEVICE

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.

Miniature Actilady device not active

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (2)

Hadassah Medical Center

Jerusalem, 91120, Israel

Location

Hadassah Medical Organization

Jerusalem, 91120, Israel

Location

MeSH Terms

Conditions

Dysmenorrhea

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Yossi Ezra

Study Record Dates

• First Submitted: March 3, 2009
• First Posted: March 4, 2009
• Study Start: May 1, 2010
• Primary Completion: May 1, 2013
• Study Completion: October 1, 2013
• Last Updated: November 13, 2013

Record last verified: 2013-11

Locations

IL (2)