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

This study is designed to learn about hair changes in adults taking Oriahnn (a pill that combines elagolix with estradiol and norethindrone acetate) to treat heavy menstrual bleeding caused by uterine fibroids. It’s an observational, prospective cohort study, so researchers will follow real-world users over time to see how often meaningful hair loss happens, how soon it starts, the way it shows (thinning, shedding, and patterns), whether it improves or goes away, and whether there are differences by race. About 1,600 women in the United States, aged 18–50, will be enrolled and followed for up to 2 years, with hair-related outcomes tracked up to about 3.5 years. All participants will receive Oriahnn as prescribed by their doctor.

To join, you must be female, 18–50 years old, have uterine fibroids with heavy bleeding, and plan to start Oriahnn within about 2 weeks of joining. You’ll need to be able to provide scalp photographs. Part 2 of the study will focus on a smaller group of participants who develop meaningful hair loss. Key exclusions include a history of hair loss or conditions causing hair loss, contraindications to Oriahnn, recent hormone treatments for fibroids, pregnancy, thyroid problems, scalp infections, or medicines known to cause hair loss. Participants complete quarterly questionnaires about their hair and symptoms, with no extra procedures beyond routine care. The study is sponsored by AbbVie and conducted at least at one site in Virginia. This is an observational study, not a test of a new drug.

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)