DysmenorrheaPhase 1NCT00855829
A Feasibility Study Designed to Assess the Efficacy of the ActiLady Device in Adult Female Subjects With Dysmenorrhea
A Phase 1 study testing Miniature Actilady device active and Miniature Actilady device not active in people with Dysmenorrhea, run by Hadassah Medical Organization at 2 sites in Israel.
Trial summary
ActiLady refers is employing targeted pressure waves, with the goal of reducing the pain associated with menstruation (clinically known as dysmenorrhea). Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Dysmenorrhea
- What is being tested?
- Miniature Actilady device active and Miniature Actilady device not active
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 2 sitesIsrael
- Study dates
- May 2010to Oct 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Hadassah Medical Center
Jerusalem, 91120
Hadassah Medical Organization
Jerusalem, 91120
About this study
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.
ActiLady refers is employing targeted pressure waves, with the goal of reducing the pain associated with menstruation (clinically known as dysmenorrhea).
- Conditions
- Dysmenorrhea
- Being tested
- Miniature Actilady device active, Miniature Actilady device not active
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Miniature Actilady device activeDevice
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 activeDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Miniature Actilady device active | Active 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). Receives: Device: Miniature Actilady device active |
| Miniature Actilady device not active | Sham comparator | 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). Receives: Device: Miniature Actilady device not active |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety of a novel method and device called ActiLady.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2009 (estimated)
- Study startMay 2010
- Primary completionMay 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysmenorrheaStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ezra Yosi, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00855829
- Sponsor's protocol ID
- galmedics-HMO-CTIL
- Status last verified
- Nov 2013
- First submitted
- 3 Mar 2009
- Last updated
- 13 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00855829
- Acronym / sponsor ID
- galmedics-HMO-CTIL
- Conditions
- Dysmenorrhea
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- May 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 4 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
ActiLady refers is employing targeted pressure waves, with the goal of reducing the pain associated with menstruation (clinically known as dysmenorrhea).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Miniature Actilady device active | Active comparator | Device: Miniature Actilady device activeone 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). |
| Miniature Actilady device not active | Sham comparator | Device: Miniature Actilady device not activeSham 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). |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Miniature Actilady device activeDevices: Targeted pressure waves are created by two kind of methods ActiLady). 1. 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. 2. Self manufactured device inserted into the vaginal cavity and creating subsound pressure waves. | Device | Miniature Actilady device active |
| Miniature Actilady device not activeDevices: 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. | Device | Miniature Actilady device not active |
Primary outcome
To evaluate the safety of a novel method and device called ActiLady.
Time frame: 6 months
1 secondary outcome
* 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Miniature Actilady device active and Miniature Actilady device not active in people with Dysmenorrhea, run by Hadassah Medical Organization at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety of a novel method and device called ActiLady. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2013; AzTrials last refreshed its copy on 6 Nov 2026.