Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04685343 · ClinicalTrials.gov registry record · NA
Behavioral and Neural Phenotypes of Primary Dysmenorrhea in Adolescents
A NA study, sponsored by Mclean Hospital.
- Completed
- Registry status
- NA
- Development phase
- 164
- Enrollment target
NCT04685343: Completed NA study, sponsored by Mclean Hospital.
NCT04685343 is a NA study that has completed, run by Mclean Hospital. The registered enrollment target is 164 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04685343, a NA study, has completed, sponsored by Mclean Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 164 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Rating of average pain during the first two days of the most recent menstrual period on a 0 (no pain) to 10 (worst pain possible) numeric rating scale.
Interventions
- OTHER fMRI
- BEHAVIORAL Quantitative Sensory Testing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 164 participants |
| Start Date | 2020-12-14 |
| Est. Completion | 2025-12-24 |
| Phase | NA |
What the finished NCT04685343 record still lists
NCT04685343 is an interventional study that assigns participants to a tested intervention. The registered 164 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which fMRI is the first listed.
NCT04685343 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04685343 about?
NCT04685343 is a clinical study titled "Behavioral and Neural Phenotypes of Primary Dysmenorrhea in Adolescents". 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...
What is the current status of trial NCT04685343?
This trial is currently completed. It is a NA study. The enrollment target is 164 participants. The study started on 2020-12-14. Estimated completion is 2025-12-24.
What interventions are being tested in trial NCT04685343?
The interventions under investigation include: fMRI (OTHER), Quantitative Sensory Testing (BEHAVIORAL).
Who is sponsoring clinical trial NCT04685343?
This trial is sponsored by Mclean Hospital, which has 140 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04685343's enrollment target sits among peer trials
164 626th of 2000 higher than 1,374 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04891289 · 164 participants · Phase 2
Gemcitabine and Oxaliplatin Chemotherapy With or Without a Floxuridine and Dexamethasone Pump in People With Cholangiocarcinoma That Cannot Be Removed With Surgery
- NCT04893226 · 164 participants · NA
Time-Restricted Feeding Intervention in Metabolically-Unhealthy Postmenopausal Women
- NCT05270213 · 164 participants · Phase 1
Evaluation of RBS2418 in Subjects With Advanced, Metastatic Solid Tumors
- NCT05543681 · 164 participants · Phase 2
Clinical Trial on Agitation in Alzheimer's Dementia
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI