ClinicalTrials.gg
Not yet recruitingNCT07176780Updated Jun 16, 2026

Effect of Semiconductor Embedded Wearable Sleeve on Treatment of Primary Dysmenorrhea Symptoms

An interventional study of Semiconductor embedded body sleeve and Placebo Non-Compressive Body Sleeve in Primary Dysmenorrhea, Primary Dysmenorrhea (PD) and Menstrual Cramps, sponsored by University of California, Davis. Not yet recruiting. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-16.

Sponsored by University of California, Davis · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study 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. 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.

02

Conditions studied

  • Primary Dysmenorrhea
  • Primary Dysmenorrhea (PD)
  • Menstrual Cramps
  • Women's Health

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Keywords

  • Menstrual Cramps
  • Dysmenorrhea
  • Primary Dysmenorrhea
  • Women's Health
03

In context

Dysmenorrhea

430 studies on the registry are indexed under Dysmenorrhea; 107 are open to participants now.

This study's planned enrollment of 100 is above the median of 62 across 363 interventional studies indexed under Dysmenorrhea.

Browse Dysmenorrhea studies →

Lead sponsor

University of California, Davis is the lead sponsor of 809 studies on the registry; 142 are open to participants now.

Of its 67 completed or terminated interventional studies of FDA-regulated products, 43 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 and adhere to study requirements

Exclusion criteria

Exclusion Criteria:

  • 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 methods:

    1. intrauterine device
    2. oral contraceptives,
    3. contraceptive patch,
    4. implant (Nexplanon),
    5. shot (Depo-Provera),
    6. 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 drug or used any investigational device within the 30 days prior to consent.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    Active Device

    Device embedded with semiconductors

    Device: Semiconductor embedded body sleeve

  • Placebo comparator
    Placebo Device

    Identical device absent of semiconductors

    Device: Placebo Non-Compressive Body Sleeve

Interventions

  • DeviceSemiconductor embedded body sleeve

    The active device contains semiconductors embedded into the body sleeve fabric

  • DevicePlacebo Non-Compressive Body Sleeve

    Identical body sleeve absent of semiconductors

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 6 months

Secondary outcomes

  1. 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)

    Time frame: 6 months

  2. 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.

    Time frame: 6 months

  3. 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)

    Time frame: 6 months

  4. 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)

    Time frame: 6 months

  5. Changes in menstrual symptom duration

    Changes in menstrual symptom duration compared to placebo group as reported by participants at each menstrual cycle.

    Time frame: 6 months

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2026; primary completion for Dec 2026, 0 months later.

Of 178 non-industry interventional studies with no phase under Dysmenorrhea, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 16. This study's planned 0 months is below that.

Counting every sponsor, half of 188 studies reached it within 8 months; a quarter within 3 and three quarters within 16.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 9, 2025
First posted
Sep 16, 2025
StartEst.
Dec 2026
Primary completionEst.
Dec 2026
CompletionEst.
Mar 2027
Last update
Jun 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07176780
Collaborators
INCREDIWEAR HOLDINGS, INC.
Responsible party
Sponsor
First posted
Sep 16, 2025
Start date
Dec 2026 (estimated)
Primary completion
Dec 2026 (estimated)
Completion
Mar 2027 (estimated)
Last update
Jun 16, 2026

Study contacts

UC Davis Health Ob/Gyn Research
Contact
obgynresearch@health.ucdavis.edu
916-734-6846

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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