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

Hadassah Medical Center

Status and phase: Completed; Phase 1

Conditions: Dysmenorrhea

Treatments: Device: Miniature Actilady device not active; Device: Miniature Actilady device active

Study type: Interventional

Funder types: Other

Identifiers

NCT00855829

galmedics-HMO-CTIL

Details and patient eligibility

About

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

Enrollment: 24 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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24 participants in 2 patient groups

Miniature Actilady device active

Active Comparator group

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).

Treatment:

Device: Miniature Actilady device active

Miniature Actilady device not active

Sham Comparator group

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).

Treatment:

Device: Miniature Actilady device not active