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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ezra Yosi, Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00855829
First received: March 3, 2009
Last updated: November 10, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Dysmenorrhea
Device: Miniature Actilady device active
Device: Miniature Actilady device not active
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • To evaluate the safety of a novel method and device called ActiLady. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • * 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. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: May 2010
Study Completion Date: October 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  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.
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.


  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00855829

Locations
Israel
Hadassah Medical Organization
Jerusalem, Israel, 91120
Hadassah Medical Center
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
  More Information

No publications provided

Responsible Party: Ezra Yosi, Prof. Yossi Ezra, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00855829     History of Changes
Other Study ID Numbers: galmedics-HMO-CTIL
Study First Received: March 3, 2009
Last Updated: November 10, 2013
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Dysmenorrhea
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on July 28, 2014