Hormonal Management of Heavy Menstrual Bleeding in Adolescents

NCT06740929 | Recruiting

• 1 other identifier: 2024-01578
• Study Type: observational
• Target: 163
• Locations: 1 country
• Sites: 1

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.

Conditions

Heavy Menstrual Bleeding; Bleeding Disorder

Keywords

heavy menstrual bleeding; bleeding disorder; adolescent; contraception; menstrual management

Outcome Measures

Primary Outcomes (1)

• Percentage of reduction in menstrual blood loss

  Using PBAC (pictorial blood loss assessment chart)

  6 months after hormonal medication initiation

Secondary Outcomes (5)

• Percentage of reduction in menstrual blood loss

  3 months following hormonal medication initiation

• Percentage of reduction in menstrual blood loss

  12 months after hormonal medication initiation

• Quality of life

  at baseline, 3 months, 6 months and 12 months

• Hemoglobin and ferritin levels changes

  at baseline, 6 months and 12 months

• Changes in thrombin generation markers

  at baseline and 6 months

Eligibility Criteria

• Age: Up to 25 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adolescents and young adults presenting to the gynecology consultation at HUG.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Geneva University Hospitals

Geneva, 1205, Switzerland

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Thrombin generation markers

MeSH Terms

Conditions

Menorrhagia; Hemostatic Disorders

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Dehlia Moussaoui, MD

CONTACT

+41 22 372 33 87; dehlia.moussaoui@hug.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 14, 2024
• First Posted: December 18, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 24, 2024

Record last verified: 2024-12

Locations

CH (1)