EQUIPT: Evaluating Quality of Life in Period Treatment

Overview

This prospective observational study will characterize quality of life and quantitative blood loss for adolescents with heavy menstrual bleeding (HMB) before and after starting therapy for menstrual suppression. The study is comparing the effectiveness of hormonal therapy, antifibrinolytics, and intrauterine devices (IUDs) at improving HMB in adolescents with an underlying bleeding disorder.

Population: Subjects between 9 and 21 years of age, natal female, with uterus present and menstruating, and referred for self-reported heavy menstrual bleeding.

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Intervention

This is an observational study that involves participants completing questionnaires and research staff abstracting data from participant EMRs. Participants are enrolled into different study arms depending on 1) whether they have been diagnosed with a bleeding disorder or are still being worked up for a bleeding disorder at enrollment and 2) how long they’ve been on menstrual suppression treatment: just starting or 0-2 months, 3-8 months, or 9-12 months. Participants are followed for a period of up to 15 months post-treatment initiation and complete surveys at up to 3 timepoints, with the length of follow-up and number of visits depending on study arm. Participants have the option of completing the surveys via a REDCap link sent to their email or on paper. Research staff enter data collected as part of standard of care during routine clinic visits into a REDCap database.

Outcomes

Improvement in quality of life scores is expected. The primary outcome for this study is change in menstrual impact as indicated by questionnaire score at 9-15 months when compared to baseline.

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Trial Information

Target enrollment: Goal is 20 participants at our site. Across all study sites, the goal is 500-600 patients. Our IRB application has a target enrollment/enrollment limit of 50 patients enrolled out of 100 screened.

Duration: 4 years

Funder: Emory University and Children’s Healthcare of Atlanta (CHOA); supported by Hemophilia of Georgia Von Willebrand Disease Program Grant

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UTHealth Houston Principal Investigator