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

Last updated: September 11, 2025
Sponsor: AbbVie
Overall Status: Trial Not Available

Phase

N/A

Condition

Female Hormonal Deficiencies/abnormalities

Uterina Myoma

Sarcoma (Pediatric)

Treatment

N/A

Clinical Study ID

NCT06058728
P20-400
  • Ages 18-50
  • Female

Study Summary

Uterine Fibroids (UF) are benign smooth muscle neoplasms of the uterus that affect women of reproductive age. UFs are one of the leading causes of hospitalizations for gynecological disorders and often lead to hysterectomy. In this study, women with heavy menstrual bleeding (HMB) due to UF who are being treated with Oriahnn will be followed to establish the incidence rate, time to onset, extent, pattern, and resolution of meaningful hair loss, as well as any racial differences.

Oriahnn is an approved drug for the management of HMB associated with UF. All study participants will receive Oriahnn as prescribed by their study doctor in accordance with approved local label. Study Participants will be followed for up 24 months (part 1). Approximately 1600 participants aged 18-50 years will be enrolled at 1 site in the United States.

Participants will receive oral Oriahnn as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for 24 months.

There is expected to be no additional burden for participants in this trial. Participants will complete questionnaires on a quarterly basis.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Part 1:

  • International Classification of Disease-10 (ICD-10) diagnosis codes for both uterinefibroids (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 studyenrollment.

  • 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

Exclusion Criteria:

  • Current or history of hair thinning, hair loss, or alopecia (defined asphysician-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, tineacapitis).

  • Have taken medications or undergone therapies that may cause alopecia, hairloss, or both. This includes but is not limited to chemotherapy, checkpointinhibitors, epidermal growth factor antagonists, or radiation anywhere on thebody.

  • Initiation or changes in medications or doses for the management of thyroid diseases

  • Any other medical condition or surgery requiring hospitalization (other than UF)

Study Design

Study Start date:
December 20, 2023
Estimated Completion Date:
August 31, 2026

Connect with a study center

  • Dorsata /ID# 252675

    Arlington, Virginia 22201-5330
    United States

    Site Not Available

  • Dorsata /ID# 252675

    Arlington 4744709, Virginia 6254928 22201-5330
    United States

    Site Not Available

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