Heavy Menstrual BleedingJAdoRENCT06740929
Hormonal Management of Heavy Menstrual Bleeding in Adolescents
An observational study of Heavy Menstrual Bleeding and Bleeding Disorder, run by University Hospital, Geneva at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 25 years, women only
- Conditions the study is for
- Heavy Menstrual Bleeding, Bleeding Disorder
- How many people
- 163 participants
- Where
- 1 siteSwitzerland
- Study dates
- 17 Dec 2024to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 25 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Adolescents and young adults presenting to the gynecology consultation at HUG.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Geneva University Hospitals
Geneva, 1205
Dehlia Moussaoui, MD, +41 22 372 33 87, dehlia.moussaoui@hug.ch
About this study
Official title: Hormonal Management of Heavy Menstrual Bleeding in Adolescents and Young Adults With and Without a Bleeding Disorder: a Prospective Observational Cohort Study
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.
Read the 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.
- Conditions
- Heavy Menstrual Bleeding, Bleeding Disorder
- Keywords
- heavy menstrual bleeding, bleeding disorder, adolescent, contraception, menstrual management
- Medical subject headings
- Menorrhagia, Hemostatic Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of reduction in menstrual blood loss
Using PBAC (pictorial blood loss assessment chart)
Measured: 6 months after hormonal medication initiation
Secondary outcomes (5)
Percentage of reduction in menstrual blood loss
Using PBAC
Measured: 3 months following hormonal medication initiation
Percentage of reduction in menstrual blood loss
Using PBAC
Measured: 12 months after hormonal medication initiation
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.
Measured: at baseline, 3 months, 6 months and 12 months
Hemoglobin and ferritin levels changes
Blood samples to measure hemoglobin and ferritin
Measured: at baseline, 6 months and 12 months
Changes in thrombin generation markers
Blood sample
Measured: at baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start17 Dec 2024
- Primary completionJul 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heavy Menstrual BleedingStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 163 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dehlia Moussaoui, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06740929
- Sponsor's protocol ID
- 2024-01578
- Acronym
- JAdoRE
- Status last verified
- May 2026
- First submitted
- 14 Dec 2024
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hormonal Management of Heavy Menstrual Bleeding in Adolescents and Young Adults With and Without a Bleeding Disorder: a Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT06740929
- Acronym / sponsor ID
- JAdoRE / 2024-01578
- Conditions
- Heavy Menstrual Bleeding, Bleeding Disorder
- Keywords
- heavy menstrual bleeding, bleeding disorder, adolescent, contraception, menstrual management
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 163 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 17 Dec 2024 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 18 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Adolescents and young adults presenting to the gynecology consultation at HUG.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of reduction in menstrual blood loss
Time frame: 6 months after hormonal medication initiation
Using PBAC (pictorial blood loss assessment chart)
5 secondary outcomes
Percentage of reduction in menstrual blood loss
Time frame: 3 months following hormonal medication initiation
Percentage of reduction in menstrual blood loss
Time frame: 12 months after hormonal medication initiation
Quality of life
Time frame: at baseline, 3 months, 6 months and 12 months
Hemoglobin and ferritin levels changes
Time frame: at baseline, 6 months and 12 months
Changes in thrombin generation markers
Time frame: at baseline and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heavy Menstrual Bleeding and Bleeding Disorder, run by University Hospital, Geneva at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dehlia Moussaoui, MD (+41 22 372 33 87, dehlia.moussaoui@hug.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of reduction in menstrual blood loss (time frame: 6 months after hormonal medication initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.