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

This study is currently recruiting participants.

Verified October 2012 by Hadassah Medical Organization

Sponsor:

Information provided by (Responsible Party):

Ezra Yosi, Hadassah Medical Organization

ClinicalTrials.gov Identifier:

NCT00855829

First received: March 3, 2009

Last updated: October 1, 2012

Last verified: October 2012

History of Changes

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:

MedlinePlus related topics: Menstruation

U.S. FDA Resources

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
Estimated 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). 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.
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.

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).

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.

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:

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

Contacts and Locations

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

Contacts

Contact: Yossef Ezra, MD.	972507874243	ezray@cc.huji.ac.il
Contact: Hadas Lemberg, PhD	00 972 2 6777572	lhadas@hadassah.org.il

Locations

Israel
Hadassah Medical Organization	Not yet recruiting
Jerusalem, Israel, 91120
Contact: Arik Tzukert, DMD 00 972 2 6776095 arik@hadassah.org.il
Principal Investigator: Yossef Ezra, MD
Hadassah Medical Center	Not yet recruiting
Jerusalem, Israel, 91120
Contact: Yossef Ezra, MD 972507874243 ezray@cc.huji.ac.il
Principal Investigator: Yossef Ezra, MD
Hadassah Medical Center	Recruiting
Jerusalem, Israel, 91120
Contact: Yossef Ezra, MD +972-50-7874243 ezray@cc.huji.ac.il
Principal Investigator: Yossef Ezra, MD

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:	October 1, 2012
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 June 17, 2013

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