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

Dysmenorrhea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00855829
• Other study ID #: galmedics-HMO-CTIL
• 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

• Dysmenorrhea

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