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Hormonal Management of Heavy Menstrual Bleeding in Adolescents

NCT ID: NCT06740929

Last Updated: 2024-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

163 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-31

Study Completion Date

2027-12-31

Brief Summary

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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

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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

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Heavy Menstrual Bleeding Bleeding Disorder

Keywords

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heavy menstrual bleeding bleeding disorder adolescent contraception menstrual management

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Maximum Eligible Age

25 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Geneva

OTHER

Sponsor Role lead

Responsible Party

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Dehlia Moussaoui

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Geneva University Hospitals

Geneva, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Dehlia Moussaoui, MD

Role: CONTACT

Phone: +41 22 372 33 87

Email: [email protected]

Facility Contacts

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Dehlia Moussaoui, MD

Role: primary

Other Identifiers

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2024-01578

Identifier Type: -

Identifier Source: org_study_id