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New treatment option for Dysmenorrhea Primary
Official title Pain Relief From Dysmenorrhea Employing taVNS
ClinicalTrials.gov ID: NCT06912386
What this study is testing
- What it's testing
- The goal of this clinical trial is to determine if transauricular vagal nerve stimulation (taVNS) is effective in treating moderate dysmenorrhea. The main question it aims to answer is: Does taVNS reduce the number of times participants suffering from dysmenorrhea need to use rescue medication during menstruation?
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, women only
You may be able to join if
- Regular menstrual cycle (28 days ± 7 days);
- Average moderate menstrual pain (with 4 - 7 NRS scores);
- History of over-the-counter (OTC) analgesic use for the treatment of menstrual pain (at least 1 IBUPROFEN for the first two days);
- 4 consecutive monthly menstrual cycles;
- Non-pregnant status;
You likely can't join if
- Currently under medications (except for analgesic medication for menstrual cycle);
- Use of oral contraceptive;
- Secondary cause for dysmenorrhea (i.e., endometriosis, adenomyosis, uterine fibroids, or infection);
- Unstable or serious illness (e.g., kidney, liver, GIT, heart conditions, diabetes, thyroid gland function, lung conditions, chronic asthma, diagnosed...
- Current malignancy or treatment for malignancy within the previous 2 years;
- Pregnant or lactating women;
See the full eligibility criteria
- Regular menstrual cycle (28 days ± 7 days);
- Average moderate menstrual pain (with 4 - 7 NRS scores);
- History of over-the-counter (OTC) analgesic use for the treatment of menstrual pain (at least 1 IBUPROFEN for the first two days);
- 4 consecutive monthly menstrual cycles;
- Non-pregnant status;
- Agrees to use adequate birth control during the trial;
- Otherwise, healthy;
- Agree not to participate in any other clinical trial while enrolled in this trial ;
- No facial or ear pain, no recent ear trauma, no metal implants including pacemakers;
- Normal ECG, Heart Rate and Blood Pressure (systolic BP 105-130, diastolic BP 60-90, heart rate per min at rest 60-85);
- Currently under medications (except for analgesic medication for menstrual cycle);
- Use of oral contraceptive;
- Secondary cause for dysmenorrhea (i.e., endometriosis, adenomyosis, uterine fibroids, or infection);
- Unstable or serious illness (e.g., kidney, liver, GIT, heart conditions, diabetes, thyroid gland function, lung conditions, chronic asthma, diagnosed psychological or mood disorder, hypertension, any bleeding disorders...
- Current malignancy or treatment for malignancy within the previous 2 years;
- Pregnant or lactating women;
- Active smokers, nicotine use, or drug (prescription or illegal substances) abuse;
- Chronic past and/or current alcohol use (\>14 alcoholic drinks per week);
- Any condition that in the opinion of the investigator, makes the participant unsuitable for inclusion;
- Unwilling or unable to comply with protocol;
- Active genitourinary infection in the last four weeks;
- Unable to read or comprehend the informed consent;
- Unwilling to complete study procedures;
- Participated in any other clinical trial during the past 1 month;
- Personal or family history of seizure, mood, or cardiovascular disorders;
- Allergic reaction to surface electrodes.
The study team makes the final eligibility decision.
Where it's taking place
- Chengdu, Sichuan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chengdu, Sichuan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.