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NCT04685343
Behavioral and Neural Phenotypes of Primary Dysmenorrhea in Adolescents
NA trial testing Quantitative Sensory Testing in Primary Dysmenorrhea in 164 participants. Completed in 24 December 2025.
24 December 2025
Quick facts
| Lead sponsor | Mclean Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 164 |
| Start date | 14 December 2020 |
| Primary completion | 24 December 2025 |
| Estimated completion | 24 December 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Quantitative Sensory Testing
- fMRI — full drug profile →
Conditions studied
- Primary Dysmenorrhea — all drugs for Primary Dysmenorrhea →
Sponsor
Mclean Hospital
Who can join
Adults 13 to 19, female only, with Primary Dysmenorrhea. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The study will use primary dysmenorrhea (PD; menstrual pain without an identified organic cause) as a model to examine biomarkers associated with menstrual and non-menstrual bodily pain in adolescent girls, ages 13-19. Participants will undergo extensive phenotyping including pain inhibition testing and multimodal neuroimaging to obtain indices brain structure and function at baseline and 12 months later. Menstrual pain severity and non-menstrual bodily pain will be assessed monthly for 24 months. Aims of the study are: 1) to identify the central mechanisms of PD using measures of pain inhibition and brain structure and connectivity of sensorimotor, default, emotional arousal, and salience networks, 2) to determine deficits in pain inhibition and alterations in brain structure and network connectivity that predict the one-year developmental trajectories of menstrual pain and non-menstrual bodily pain, and 3) to identify the dynamic relationship between alterations in pain inhibition and brain structure and connectivity with symptom change in menstrual pain and non-menstrual bodily pain. We hypothesize that deficits in endogenous pain inhibition and alterations in brain structure, connectivity, and function of regional networks will be positively associated with menstrual pain severity ratings at baseline and predict the trajectory of menstrual and non-menstrual bodily pain over 2 years. The results are expected to identify specific mechanisms and characteristics that predict the transition from acute/cyclical pain to persistent or chronic pain, which will support the development of therapies to prevent the transition from recurrent to chronic pain in adulthood.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Validation of the menstrual sensitivity index in adolescents.
Seidman LC, Handy AB, Payne LA. · · 2025 · PMID 40787629 · DOI 10.1097/pr9.0000000000001315
Verify or expand the search:
- PubMed search for NCT04685343
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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Other recruiting trials for Primary Dysmenorrhea
Currently open trials in the same condition.
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- NCT06995287 — Evaluation of the Analgesic Effect of Intramyometrial Botulinum Toxin Injection Via Hysteroscopy in Severe Primary Dysme · Phase 3 · recruiting
- NCT07352982 — Transcutaneous Tibial Nerve Stimulation on Women With Primary Dysmenorrhea · NA · recruiting
- NCT07239232 — "Knee Joint Position Sense and Dynamic Balance in Females With Primary Dysmenorrhea · recruiting
- NCT07314021 — Primary Dysmenorrhea and Mobilization. · NA · active not recruiting
Other Mclean Hospital trials
Trials by the same sponsor.
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- NCT07503093 — Pilot Study of Sensor-Informed Smartphone-based Mental Health Interventions for Mood in Early Psychosis · NA · not yet recruiting
- NCT07503067 — Identifying Substance Use Consequences · recruiting
- NCT06816329 — Stress Dynamics and Familial Risk for Depression in Female Adolescents · NA · recruiting
- NCT06876129 — Pharmacologic Augmentation of TMS for Depression With D-serine · Phase 1 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04685343 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Mclean Hospital
- Last refreshed: 22 January 2026
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