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EnBrace HR for PMS With Prominent Mood Symptoms or Menstrual Related Mood Disorders

NCT04123483 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2020-01-02

No results posted yet for this study

Summary

The purpose of this study is to assess a novel nutritional supplement developed for prenatal health and mood benefits, and to determine whether there is preliminary evidence for efficacy in Menstrual Related Mood Disorders (MRMD), including PMS with Prominent Mood Symptoms and PMDD.

Conditions

  • Premenstrual Syndrome
  • Premenstrual Dysphoric Disorder
  • Premenstrual Tension
  • Menstrual Related Mood Disorder

Interventions

DRUG

EnBrace HR Softgel

Prescription folate prenatal supplement with other dietary ingredients; one multiphasic soft gelatin capsule 1x/day for 8 week study

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Marlene P Freeman, MD · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
52 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-30
Primary Completion
2021-11-30
Completion
2022-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04123483 on ClinicalTrials.gov