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

This study has been withdrawn prior to recruitment.

( We have decided to cancel this study. )

First Received: March 3, 2009 Last Updated: July 20, 2009 History of Changes

Sponsored by:	Hadassah Medical Organization
Information provided by:	Hadassah Medical Organization
ClinicalTrials.gov Identifier:	NCT00855829

Purpose

ActiLady refers to a novel method of employing targeted waves or vibrations, with the goal of reducing the pain associated with menstruation (clinically known as dysmenorrhea).

Condition	Intervention	Phase
Dysmenorrhea	Device: Targeted waves or vibrations (ActiLady).	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	A Single-Center, Randomized, Controlled, Single-Blind Feasibility Study Designed to Assess the Efficacy of the ActiLady Method 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 pain-reducing effect of ActiLady method on dysmenorrhea. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Study the relationship between menses flux and dysmenorrhea. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	April 2009
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Vaginal system: Experimental Targeted waves or vibrations.	Device: Targeted waves or vibrations (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.

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

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:	Hadassah Medical Organization ( Yossef Ezra MD )
Study ID Numbers:	galmedics-HMO-CTIL
Study First Received:	March 3, 2009
Last Updated:	July 20, 2009
ClinicalTrials.gov Identifier:	NCT00855829 History of Changes
Health Authority:	Israel: Ministry of Health

Study placed in the following topic categories:

Signs and Symptoms
Silicon
Pelvic Pain

Menstruation Disturbances
Dysmenorrhea
Pain

Additional relevant MeSH terms:

Signs and Symptoms
Pelvic Pain
Pathologic Processes

Menstruation Disturbances
Dysmenorrhea
Pain

ClinicalTrials.gov processed this record on September 11, 2009