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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00855829
Other study ID # galmedics-HMO-CTIL
Secondary ID
Status Completed
Phase Phase 1
First received March 3, 2009
Last updated November 10, 2013
Start date May 2010
Est. completion date October 2013

Study information

Verified date November 2013
Source Hadassah Medical Organization
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date October 2013
Est. primary completion date May 2013
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 35 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Israel Hadassah Medical Center Jerusalem
Israel Hadassah Medical Organization Jerusalem

Sponsors (1)

Lead Sponsor Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary To evaluate the safety of a novel method and device called ActiLady. 6 months No
Secondary * 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 No
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