Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06771583 · ClinicalTrials.gov registry record
Identification and Validation of Epigenetic Biomarkers of PMDD
A clinical trial of Premenstrual Syndrome and Menstrual Cycle, sponsored by Johns Hopkins University.
- Recruiting
- Registry status
- 500
- Enrollment target
- 1
- Study location
NCT06771583: Recruiting study of Premenstrual Syndrome and Menstrual Cycle, sponsored by Johns Hopkins University.
NCT06771583 is a study of Premenstrual Syndrome and Menstrual Cycle that is actively recruiting participants, run by Johns Hopkins University. The registered enrollment target is 500 participants, above the 52-participant average among 6 other Premenstrual Syndrome trials with a reported enrollment target (862% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06771583, a study of Premenstrual Syndrome and Menstrual Cycle, is actively recruiting participants, sponsored by Johns Hopkins University.
- RECRUITING
- Registry status
- 500 participants
- Enrollment target
- 1
- Study location
Study Summary
This research is being done to examine epigenetic markers and mood changes across the menstrual cycle, particularly in premenstrual dysphoric disorder (PMDD). The investigators previously identified epigenetic biomarkers of postpartum depression, another reproductive affective disorder, and in this study aim to determine if these biomarkers also distinguish PMDD cases from healthy controls at different points in the menstrual cycle. By collecting biological samples (such as blood) and monitoring mood changes across the menstrual cycle, the investigators will be able to determine whether these epigenetic markers are associated with PMDD. The investigators plan to study these epigenetic markers during the follicular phase (roughly the first half of the menstrual cycle, from menses until ovulation) and the luteal phase (roughly the second half of the menstrual cycle, from ovulation to menses). The investigators will study this in two groups: 1) individuals who do NOT have premenstrual mood symptoms, and 2) individuals with premenstrual syndrome/premenstrual dysphoric disorder (PMS/PMDD). The results will provide a comprehensive view of the changes in these systems across the menstrual cycle. This will add to the investigators understanding of the mechanisms that may cause PMS/PMDD.
Primary Outcome
In the luteal phase, DNA methylation variations at HP1BP3, TTC9B will distinguish controls from individuals with PMDD. In the follicular phase, DNA methylation variations at HP1BP3 and TTC9B will not distinguish controls from PMDD. The investigators will be collecting dried blood spots and assaying these epigenetic markers using various DNA methylation techniques.
Conditions Studied
Study Locations (1)
Maryland
- Johns Hopkins Reproductive Mental Health Center - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2025-09-12 |
| Est. Completion | 2031-02-15 |
What NCT06771583 shows while recruiting
NCT06771583 is an observational study that tracks outcomes without assigning an intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, above the 52-participant average among 6 other Premenstrual Syndrome trials with a reported enrollment target (862% higher).
The record links to 5 conditions, with Premenstrual Syndrome appearing as the primary indexed condition, and to 0 interventions.
NCT06771583 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT06771583 about?
NCT06771583 is a clinical study titled "Identification and Validation of Epigenetic Biomarkers of PMDD". This research is being done to examine epigenetic markers and mood changes across the menstrual cycle, particularly in premenstrual dysphoric disorder (PMDD). The investigators previously identified epigenetic biomarkers of postpartum depression, another reproductive affective disorder, and in this ...
What is the current status of trial NCT06771583?
This trial is currently recruiting. The enrollment target is 500 participants. The study started on 2025-09-12. Estimated completion is 2031-02-15.
What conditions does trial NCT06771583 study?
This clinical trial studies the following conditions: Premenstrual Syndrome, Menstrual Cycle, Premenstrual Dysphoric Disorder (PMDD), PMDD, Premenstrual Syndrome-PMS.
Who is sponsoring clinical trial NCT06771583?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06771583 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Premenstrual Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Moderate Aerobic Exercise for Managing Menstrual Cycle Symptoms
RECRUITING · NA
-
Antidepressant Treatment for Premenstrual Syndrome and Premenstrual Dysphoric Disorder
COMPLETED · Phase 1
-
Effects of a Female Hormone Balance Supplement on Symptoms of Polycystic Ovary Syndrome and Severe Premenstrual Syndrome
COMPLETED · NA
-
Effects of a Female Hormone Balance Supplement on Premenstrual Syndrome Symptoms
COMPLETED · NA
-
An Investigation Into the Efficacy of a Botanical Supplement to Provide Period Relief
COMPLETED · Phase 1
-
A Study to Evaluate the Effect of Funk It Cycle Bites on PMS
COMPLETED · NA
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
- NCT00001230 · 500 participants
Host Response to Infection and Treatment in Filarial Diseases
- NCT00001529 · 500 participants
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
- NCT00697411 · 500 participants
Study of Selected X-Linked Disorders: Aicardi Syndrome
- NCT00903110 · 500 participants
Global Patient Registry to Monitor Long-term Safety and Effectiveness of Increlex® in Children and Adolescents With Severe Primary Insulin-like Growth Factor-1 Deficiency (SPIGFD).
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