Primary DysmenorrheaNCT07176780
Effect of Semiconductor Embedded Wearable Sleeve on Treatment of Primary Dysmenorrhea Symptoms
A study testing Semiconductor embedded body sleeve in people with Primary Dysmenorrhea and Primary Dysmenorrhea (PD), run by University of California, Davis.
Trial summary
This study is looking to test a non-compressive semiconductor embedded body sleeve for treatment of primary dysmenorrhea symptoms. Dysmenorrhea is the lower abdominal pain (sometimes referred to as "cramping") experienced during menstruation (monthly "period"), affecting up to 94% of people aged from 10-20 years old. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Dysmenorrhea, Primary Dysmenorrhea (PD), Menstrual Cramps
- What is being tested?
- Semiconductor embedded body sleeve
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Self-reported primary dysmenorrhea during past three menstrual cycles
- Age 18-45 inclusive at the time of consent
- Self-reported typical primary dysmenorrhea symptom pain greater than 4 on a 1-10 visual analog scale (VAS)
- History of regular menstrual cycles with a usual length of 21 to 35 days
- Willing and able to provide informed consent and adhere to study requirements
Who cannot join
- History of neurological conditions, including multiple sclerosis or Parkinson's disease
- Secondary dysmenorrhea including confirmed or suspected endometriosis or fibroids or intrauterine device
- Self-reported size not available in study device
- Pregnant or planning to become pregnant during the study
- Have within the past six months of enrollment, or are planning to in the next six months, start or discontinue any of the following contraceptive methods:
- intrauterine device
Show all 18Show fewer
- oral contraceptives,
- contraceptive patch,
- implant (Nexplanon),
- shot (Depo-Provera),
- vaginal ring
- Chronic pain conditions unrelated to primary dysmenorrhea
- Auto-immune or auto-inflammatory diseases
- Has used within the last 90 days or is planning to use nicotine-containing products
- History of metabolic disorders
- Active infection (local or systemic) that, in the opinion of the investigator, would prevent usage of the device
- In the opinion of the investigator, any other criteria or condition that could increase the risk associated with study participation or study treatment or could interfere with the interpretation of study results
- Have taken any investigational drug or used any investigational device within the 30 days prior to consent.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Semiconductor Embedded Wearable Sleeve on the Treatment and Mitigation of Primary Dysmenorrhea Symptoms: A Randomized, Double-Blinded, Placebo-Controlled Clinical Trial
This study is looking to test a non-compressive semiconductor embedded body sleeve for treatment of primary dysmenorrhea symptoms. Dysmenorrhea is the lower abdominal pain (sometimes referred to as "cramping") experienced during menstruation (monthly "period"), affecting up to 94% of people aged from 10-20 years old. The semiconductor embedded fabric increases blood circulation through activation of the embedded elements with body heat while worn and releases energy waves as well as negative ions. This energy has an effect inside the body that increases oxygen and nutrient flow to tissues, and can help to decrease pain and inflammation. This study is testing this technology to see if it can be used as a non-pharmacological treatment for menstrual cramping.
- Being tested
- Semiconductor embedded body sleeve, Placebo Non-Compressive Body Sleeve
- Keywords
- Menstrual Cramps, Dysmenorrhea, Primary Dysmenorrhea, Women's Health
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semiconductor embedded body sleeveDevice
The active device contains semiconductors embedded into the body sleeve fabric
Placebo Non-Compressive Body SleeveDevice
Identical body sleeve absent of semiconductors
| Study group | Role | What they receive |
|---|---|---|
| Active Device | Active comparator | Device embedded with semiconductors Receives: Device: Semiconductor embedded body sleeve |
| Placebo Device | Placebo comparator | Identical device absent of semiconductors Receives: Device: Placebo Non-Compressive Body Sleeve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant-Reported Changes in Pain
Reduction in menstrual symptom severity as determined by the Visual Analog Scale (VAS) compared to placebo group:
Visual Analog Scale for Pain (VAS) Minimum value: 0 (no pain) Maximum value: 10 (worst possible pain)
Measured: 6 months
Secondary outcomes (5)
Participant-Reported Changes in Quality of Life
Improvement in health-related quality of life as determined by the Short Form quality of life enjoyment and satisfaction questionnaire (Q-LES-Q-SF) compared to placebo group.
Q-LES-Q-SF:
Lowest score: 14 (indicating very poor quality of life) Highest score: 70 (indicating very good quality of life)
Measured: 6 months
Changes in oral medication intake compared to placebo group
As measured by collecting concomitant medication information at baseline and changes throughout participation in the study.
Measured: 6 months
Changes in Participant Pain Score (SF-MPQ-2)
Changes in participant menstrual pain as determined by menstrual pain questionnaire, Short Form McGill Pain Questionnaire (SF-MPQ-2), compared to placebo group.
SF-MPQ-2:
Lowest score: 0 (no pain) Highest score: 10 (worst possible pain)
Measured: 6 months
Changes in participant function in daily life
Changes in participant function/distress as determined by Menstrual Distress Questionnaire (MEDI-Q), compared to placebo group.
MEDI-Q:
Lowest score: 0 (no distress) Highest score: 5 (very much distress)
Measured: 6 months
Changes in menstrual symptom duration
Changes in menstrual symptom duration compared to placebo group as reported by participants at each menstrual cycle.
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 posted16 Sep 2025
- Study startDec 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- INCREDIWEAR HOLDINGS, INC.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07176780
- Sponsor's protocol ID
- 2264207
- Status last verified
- Jun 2026
- First submitted
- 9 Sep 2025
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Semiconductor Embedded Wearable Sleeve on the Treatment and Mitigation of Primary Dysmenorrhea Symptoms: A Randomized, Double-Blinded, Placebo-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07176780
- Acronym / sponsor ID
- 2264207
- Keywords
- Menstrual Cramps, Dysmenorrhea, Primary Dysmenorrhea, Women's Health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- INCREDIWEAR HOLDINGS, INC.
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 16 Sep 2025 (actual)
- 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.
This study is looking to test a non-compressive semiconductor embedded body sleeve for treatment of primary dysmenorrhea symptoms. Dysmenorrhea is the lower abdominal pain (sometimes referred to as "cramping") experienced during menstruation (monthly "period"), affecting up to 94% of people aged from 10-20 years old. The semiconductor embedded fabric increases blood circulation through activation of the embedded elements with body heat while worn and releases energy waves as well as negative ions. This energy has an effect inside the body that increases oxygen and nutrient flow to tissues, and can help to decrease pain and inflammation. This study is testing this technology to see if it can be used as a non-pharmacological treatment for menstrual cramping.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Device | Active comparator | Device: Semiconductor embedded body sleeveDevice embedded with semiconductors |
| Placebo Device | Placebo comparator | Device: Placebo Non-Compressive Body SleeveIdentical device absent of semiconductors |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Self-reported primary dysmenorrhea during past three menstrual cycles
- Age 18-45 inclusive at the time of consent
- Self-reported typical primary dysmenorrhea symptom pain greater than 4 on a 1-10 visual analog scale (VAS)
- History of regular menstrual cycles with a usual length of 21 to 35 days
- Willing and able to provide informed consent and adhere to study requirements
Key exclusion criteria (18 listed)
- History of neurological conditions, including multiple sclerosis or Parkinson's disease
- Secondary dysmenorrhea including confirmed or suspected endometriosis or fibroids or intrauterine device
- Self-reported size not available in study device
- Pregnant or planning to become pregnant during the study
- Have within the past six months of enrollment, or are planning to in the next six months, start or discontinue any of the following contraceptive methods:
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 |
|---|---|---|
| Semiconductor embedded body sleeveThe active device contains semiconductors embedded into the body sleeve fabric | Device | Active Device |
| Placebo Non-Compressive Body SleeveIdentical body sleeve absent of semiconductors | Device | Placebo Device |
Primary outcome
Participant-Reported Changes in Pain
Time frame: 6 months
Reduction in menstrual symptom severity as determined by the Visual Analog Scale (VAS) compared to placebo group: Visual Analog Scale for Pain (VAS) Minimum value: 0 (no pain) Maximum value: 10 (worst possible pain)
5 secondary outcomes
Participant-Reported Changes in Quality of Life
Time frame: 6 months
Changes in oral medication intake compared to placebo group
Time frame: 6 months
Changes in Participant Pain Score (SF-MPQ-2)
Time frame: 6 months
Changes in participant function in daily life
Time frame: 6 months
Changes in menstrual symptom duration
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Semiconductor embedded body sleeve in people with Primary Dysmenorrhea and Primary Dysmenorrhea (PD), run by University of California, Davis.
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 5 inclusion and 18 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: opening soon, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact UC Davis Health Ob/Gyn Research (916-734-6846, obgynresearch@health.ucdavis.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant-Reported Changes in Pain (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 16 Jun 2026.