A Study to Evaluate Changes in Hair in Adult Participants Taking Oral Oriahnn Capsules With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF)

Launched by ABBVIE · Sep 22, 2023

Keywords

ClinConnect Summary

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Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• Part 1:
• • International Classification of Disease-10 (ICD-10) diagnosis codes for both uterine fibroids (UF) (D25.X) and heavy menstrual bleeding (HMB), defined as menorrhagia (N92.0, N92.4) or menometrorrhagia (N92.1) in the electronic health record (EHR) system.
• • Plans to initiate or has initiated Oriahnn treatment within 14 days of study enrollment.
• • Able to provide photographs of their scalp within 14 days of Oriahnn initiation, based on instruction provided.
• Part 2:
• • - Changes in thickness, fullness or pattern of hair that results in less hair than normal, or hair shedding that is increased from normal in the Hair Questionnaire.
• Exclusion Criteria:
• • Current or history of hair thinning, hair loss, or alopecia (defined as physician-diagnosed or patient-reported hair loss).
• • Have a contraindication to receive Oriahnn per Prescribing Information.
• • Any of the following occurrences within 180 days prior to Oriahnn prescription.
• • Prescription for Oriahnn, another gonadotropin releasing hormone (GnRH) antagonist \[including Myfembree (relugolix, estradiol/norethindrone acetate\]) or GnRH agonist.
• • Pregnancy/Childbirth.
• • New diagnosis of thyroid disease.
• • New diagnosis of inflammation or infection of the scalp (e.g., psoriasis, tinea capitis).
• • Have taken medications or undergone therapies that may cause alopecia, hair loss, or both. This includes but is not limited to chemotherapy, checkpoint inhibitors, epidermal growth factor antagonists, or radiation anywhere on the body.
• • Initiation or changes in medications or doses for the management of thyroid diseases
• • Any other medical condition or surgery requiring hospitalization (other than UF)