An interventional study of Visceral Pain Stimulus in Dysmenorrhea, Dysmenorrhea Primary and Visceral Pain, sponsored by Azusa Pacific University. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-07.
Sponsored by Azusa Pacific University · Not applicable, Interventional, and Prevention
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Among 68 studies in Dysmenorrhea with a site in United States — 9 open to participants now, 11 under way, 1 of them phase 3. Dysmenorrhea · United States.
Among the 68 studies in Dysmenorrhea with a site in United States, this one is the 34th largest by planned enrollment of the 62 interventional ones that give a count, is one of 7 that started in 2025, is one of 23 with no phase, reaches primary completion later than 3 of the 10 other live ones, and was the 63rd registered.
430 studies on the registry are indexed under Dysmenorrhea; 107 are open to participants now.
Browse Dysmenorrhea studies →9 of the 68 studies in Dysmenorrhea with a site in United States are open now. Recruiting first, the newest first:
Samphire Group, Inc. · Sites in United States
Ages 18–65 · Women only · Healthy volunteers
Western University of Health Sciences · Sites in United States
Ages 20–51 · Women only
Helaina Inc. · Sites in United States
Ages 18–40 · Women only · Healthy volunteers
Samphire Group, Inc. · Sites in United States
Ages 22–45 · Women only
Zenchi, Inc. · Sites in United States
Ages 20–45 · Women only
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 57 Dysmenorrhea studies recruiting now, 7 (12%) set no upper age limit and 49 (86%) stop at 75 or younger; 11 take children under 18; 20 take healthy volunteers.
This study: 18 Years to 35 Years · female · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
68 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 13 · Phase 3 16 · Phase 4 8
First in 2004; this study’s year is marked. 7 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 60 is close to the median of 62 across 363 interventional studies indexed under Dysmenorrhea.
Median enrollment 73 across the 62 interventional studies, 291 across the 5 observational. Of the 51 that completed or were terminated, 21 (41%) have results posted.
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41 of 68 have an industry lead sponsor. The 10 most frequent:
Azusa Pacific University is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Azusa Pacific University has 1 study filed under Dysmenorrhea — fewer than ten, so there is no comparison to draw.
4 of the studies in Dysmenorrhea with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04333576Phase 3AbbVieStudy Of Oral Elagolix Tablets In Combination With Combined Oral Contraceptive Capsules/Tablets To Assess Dysmenorrhea Response In Adult Female Participants With Endometriosis And Associated Moderate To Severe Pain | 2027-07 |
| NCT07524270Helaina Inc.Effera Dose Response: Women's Health | 2026-11 |
| NCT07679074Samphire Group, Inc.CREST: Samphire Guided Care Program on Wellbeing, Work Productivity, and Quality of Life | 2027-01-01 |
| NCT07508358Kevin HellmanVaginal Sildenafil for Primary Dysmenorrhea | 2027-06 |
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Among the 68 studies in Dysmenorrhea with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this clinical trial is to determine if women with dysmenorrhea demonstrate an increased musculoskeletal and autonomic nervous system response to a painful visceral stimulus compared to controls. A secondary aim is to determine if interoceptive awareness moderates this relationship. The designed methodology aims to elucidate the intricate connections between the interoceptive and musculoskeletal systems in pain perception among female participants, providing valuable insights into the underlying mechanisms of interoceptive pain and functional musculoskeletal changes.
A case-control trial will be conducted. The experimental group will consist of at least 30 subjects with a pain rating during menstruation greater than or equal to 4. The control group will be age-matched participants with pain rating less than or equal to 3 during menstruation. The study will consist of one information and instrumentation session followed by one lab session. During the initial session, participants will fill out demographic information and the VAS to allow for stratification into experimental or control groups. They will be given an LH test kit and educated on how to perform LH tests. They will be asked to track their menstrual cycle on an app or online journal that can be shared with investigators. They will be asked to download an HRV app and be taught how to measure their HRV using their phone's camera. They will be instructed to take a one-minute measure of HRV once daily for 30 days beginning on the first day of their period.
On lab day, participants will be asked to remove clothing and put on a gown, booties, and disposable underwear to wear during testing. They will be led into a temperature-controlled environment where they will complete the testing. Testing includes HRV baseline measurement for 5 minutes, heartbeat counting for 3 short sessions (25, 35, and 45 seconds), and confidence about scoring. Next, an investigator with a certification to complete internal pelvic exams will ask the participant to lie on the table, and a student investigator will take the baseline measurement of their hip extension. The side being measured will be randomized, and only one side will be tested on each participant.
Next, the barostat probe will be inserted into the vaginal canal. The barostat will be inflated once to allow the participant to experience the sensation of the balloon. The probe will then be inflated until the participant reports the sensation of pain. The amount of distension in the balloon will be recorded, and hip mobility will again be measured. The purpose of this clinical trial is to determine if women with dysmenorrhea demonstrate an increased musculoskeletal and autonomic nervous system response to a painful visceral stimulus compared to controls.
Inclusion Criteria: Non-pregnant women, not taking hormonal , between the ages of 18 and 36 who report regular menstrual cycles are eligible for the study Exclusion Criteria: Participants will be excluded if they are currently pregnant or, have given birth within the preceding six months, are breastfeeding, or are undergoing in-vitro fertilization treatments. Exclusions also include those who have had abdominal, lumbar, or pelvic surgery within the preceding 12 months, suffer from a chronic pain condition, have an active genitourinary infection, are incontinent of bowel or bladder, or have been diagnosed with prolapse of a pelvic organ, severe labral pathology, femoral acetabular impingement (FAI), interstitial cystitis, endometriosis, pelvic inflammatory disease, irritable bowel syndrome, or other pelvic pathology. Participants reporting a cycle length of less than 28 days or longer than 35 days, those with a history of sexual assault, and those who are anovulatory without hormonal BC or amenorrheic will also be excluded.
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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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All participants will receive a visceral pain stimulus and have their hip range of motion and strength tested before and after the stimulus. Their heart rate variability will be measured throughout.
Diagnostic Test: Visceral Pain Stimulus
Participants will receive a visceral pain stimulus while being monitored for heart rate variability (HRV), and will have hip mobility and dorsiflexor strength assessed before and after.
Change in hip range of motion
The change in hip range of motion from baseline to after a visceral pain stimulus is a primary outcome measure of this study. This measurement will be compared between groups to determine if those with dysmenorrhea react to a painful stimulus differently compared to those without dysmenorrhea.
Time frame: Change from baseline to immediately after the pain stimulus is given.
Change in dorsiflexor strength
The change in strength of ankle dorsiflexors on the contralateral side of the hip being measured will also be assessed. This will be measured before and after the visceral pain stimulus to determine if there is a change. This measurement will be compared between groups to determine if those with dysmenorrhea react to a painful stimulus differently compared to those without dysmenorrhea.
Time frame: From baseline to immediately after the pain stimulus.
Heart Rate Variability
Heart rate variability will be measured throughout, and several time frames will be marked, including a 5-minute baseline within a 15-minute session, at the time of insertion of the probe, and at the pain stimulus, to determine if those with dysmenorrhea react to a painful stimulus differently compared to those without dysmenorrhea.
Time frame: From baseline to the end of the lab testing session, approximately 60 minutes.
Interoceptive awareness
Participants will also be given the multidimensional analysis of interoceptive awareness, 2nd edition (MAIA-2), to assess their interoceptive awareness.
Time frame: During the testing day, following physical pain stimulus.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — No IPD will be shared to protect confidentiality.
Started Aug 2025 (actual). Primary completion is estimated for Sep 2026, 13 months after the start.
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 13 months is above 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.
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Azusa Pacific University