Hormonal Management of Heavy Menstrual Bleeding in Adolescents
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeUp to 25
SponsorUniversity Hospital, Geneva
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Adolescents and young adults presenting to the gynecology consultation at HUG.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Percentage of reduction in menstrual blood loss
Using PBAC (pictorial blood loss assessment chart)
Time frame
6 months after hormonal medication initiationSecondary outcomes
1
Percentage of reduction in menstrual blood loss
Using PBAC
Time frame
3 months following hormonal medication initiation2
Percentage of reduction in menstrual blood loss
Using PBAC
Time frame
12 months after hormonal medication initiation3
Quality of life
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.
Time frame
at baseline, 3 months, 6 months and 12 months4
Hemoglobin and ferritin levels changes
Blood samples to measure hemoglobin and ferritin
Time frame
at baseline, 6 months and 12 monthsSponsors and contacts
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Source ClinicalTrials.gov