Hormonal Management of Heavy Menstrual Bleeding in Adolescents

Recruiting

• Conditions: Heavy Menstrual Bleeding; Bleeding Disorder

• Registration Number: NCT06740929
• Lead Sponsor: University Hospital, Geneva

Brief Summary

The goal of this study is to evaluate whether hormonal medications (such as contraceptive pill, patch, injectable progestins and hormonal intra-uterine device) have similar efficacy at managing heavy menstrual bleeding in adolescents with a bleeding disorder compared to those without. We also aim to assess the quality of life and hemoglobin and iron levels in this population.

Detailed Description

Adolescents with heavy menstrual bleeding and willing to start a hormonal medication to reduce menstrual flow are included. At baseline and during the study period, questionnaires and blood tests are performed. Adolescents with a bleeding disorder are compared to those without. Follow-up is 1 year.

Study Timeline

• Status Verified: 2024-12
• Study Start: 2024-12
• Study First Submitted: 2024-12-14
• Study First Submitted QC: 2024-12-14
• Study First Posted: 2024-12-18
• Last Update Submitted: 2024-12-18
• Last Update Posted: 2024-12-24
• Primary Completion: 2027-07
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 163

Inclusion Criteria

• Adolescents and young adults aged < 26yo
• Presenting to the gynecology consultation at HUG
• Diagnosed with heavy menstrual bleeding (PBAC > 100)
• Willing to initiate a hormonal medication to manage heavy menstrual bleeding

Exclusion Criteria

• Pregnancy or planning to become pregnant during the study period
• Already using hormonal medication for menstrual management and/or contraception
• Known anatomical uterine pathology
• Using anticoagulant or antiaggregant agents

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of reduction in menstrual blood loss	6 months after hormonal medication initiation	Using PBAC (pictorial blood loss assessment chart)

Secondary Outcome Measures

Name	Time	Method
Percentage of reduction in menstrual blood loss	12 months after hormonal medication initiation	Using PBAC
Quality of life	at baseline, 3 months, 6 months and 12 months	QoL (measured by the Pediatric Quality of Life Inventory (PedsQL) for adolescents (13-18 years old) or young adults (19-25 years old)) ; range 0-100 with higher scores representing better quality of life.
Hemoglobin and ferritin levels changes	at baseline, 6 months and 12 months	Blood samples to measure hemoglobin and ferritin
Changes in thrombin generation markers	at baseline and 6 months	Blood sample

Trial Locations

Locations (1)

Geneva University Hospitals; 🇨🇭 Geneva, Switzerland