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

Primary Purpose

Dysmenorrhea

Status
Completed
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Miniature Actilady device active
Miniature Actilady device not active
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysmenorrhea

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hadassah Medical Center
  • Hadassah Medical Organization

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Miniature Actilady device active

Miniature Actilady device not active

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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

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.

Full Information

First Posted
March 3, 2009
Last Updated
November 10, 2013
Sponsor
Hadassah Medical Organization
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1. Study Identification

Unique Protocol Identification Number
NCT00855829
Brief Title
A Feasibility Study Designed to Assess the Efficacy of the ActiLady Device in Adult Female Subjects With Dysmenorrhea
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.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hadassah Medical Organization

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysmenorrhea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Miniature Actilady device active
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Miniature Actilady device not active
Arm Type
Sham Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Miniature Actilady device active
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Miniature Actilady device not active
Intervention Description
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.
Primary Outcome Measure Information:
Title
To evaluate the safety of a novel method and device called ActiLady.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
* 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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Hadassah Medical Center
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Hadassah Medical Organization
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

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

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