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Completed

NCT Number: NCT00855829

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

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

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Key information

Conditions

Dysmenorrhea Menstruation Disturbances Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Hadassah Medical Center, Jerusalem, Israel

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Miniature Actilady device active

Device

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.

Miniature Actilady device not active

Device

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 outcomes

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

    Time frame: 6 months

Secondary outcomes

  1. * 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

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Registry information

Official study 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.

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Mar 4, 2009
Registry last updated
Nov 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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