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NCT Number: NCT06740929

Hormonal Management of Heavy Menstrual Bleeding in Adolescents

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.

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Key information

Conditions

Heavy Menstrual Bleeding Bleeding Disorder Cardiovascular Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Hemostatic Disorders Menorrhagia Menstruation Disturbances Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Hemorrhage Vascular Diseases

Age range

Up to 25 year

Sex eligibility

Female

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Percentage of reduction in menstrual blood loss

    Time frame: 6 months after hormonal medication initiation

    Using PBAC (pictorial blood loss assessment chart)

Secondary outcomes

  1. Percentage of reduction in menstrual blood loss

    Time frame: 3 months following hormonal medication initiation

    Using PBAC

  2. Percentage of reduction in menstrual blood loss

    Time frame: 12 months after hormonal medication initiation

    Using PBAC

  3. Quality of life

    Time frame: 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.

  4. Hemoglobin and ferritin levels changes

    Time frame: at baseline, 6 months and 12 months

    Blood samples to measure hemoglobin and ferritin

  5. Changes in thrombin generation markers

    Time frame: at baseline and 6 months

    Blood sample

Study contacts

Contact information is provided by the study sponsor or research team.

Dehlia Moussaoui, MD

CONTACT

[email protected]

+41 22 372 33 87

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Registry information

Official study title

Hormonal Management of Heavy Menstrual Bleeding in Adolescents and Young Adults With and Without a Bleeding Disorder: a Prospective Observational Cohort Study

Acronym: JAdoRE

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Dec 18, 2024
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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