Status:
COMPLETED
A Feasibility Study Designed to Assess the Efficacy of the ActiLady Device in Adult Female Subjects With Dysmenorrhea
Lead Sponsor:
Hadassah Medical Organization
Conditions:
Dysmenorrhea
Eligibility:
FEMALE
18-35 years
Phase:
PHASE1
Brief Summary
ActiLady refers is employing targeted pressure waves, with the goal of reducing the pain associated with menstruation (clinically known as dysmenorrhea).
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2013
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00855829
Start Date
May 1 2010
End Date
October 1 2013
Last Update
November 13 2013
Active Locations (2)
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1
Hadassah Medical Center
Jerusalem, Israel, 91120
2
Hadassah Medical Organization
Jerusalem, Israel, 91120