A Study to Evaluate Changes in Hair in Adult Participants Taking Oral Oriahnn Capsules With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF)
Key facts
- Who runs it
- AbbVie
- Where
- Arlington, United StatesSee the site
- Trial code
- Status
- Withdrawn
- Started
- 20 Dec 2023
- Ended
- Aug 2026
- Type of study
- Observational, 2 groups
- Record updated
- 17 September 2025
- Why it stopped
- Company Decision
Who can take part
- Age
- 18 years to 50 years
- Sex
- Women only
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Current or history of hair thinning, hair loss, or alopecia (defined as physician-diagnosed or patient-reported hair loss)
- Initiation or changes in medications or doses for the management of thyroid diseases
- Any other medical condition or surgery requiring hospitalization (other than UF)
- Have a contraindication to receive Oriahnn per Prescribing Information
Where in United States
- Dorsata /ID# 252675Arlington, United States
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- Part 1 - Oriahnn Exposure Cohort
Participants prescribed Oriahnn for management of heavy menstrual bleeding (HMB) due to uterine fibroids (UF).
- Part 2 - Nested Hair Loss Cohort
Participants prescribed Oriahnn for management of HMB due to UF, with meaningful hair loss.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Prospective, Single-Arm, Descriptive Observational Study to Evaluate Changes in Hair in Women Exposed to Oriahnn® (Elagolix 300 mg BID With Estradiol 1 mg/Norethindrone Acetate 0.5 mg QD)
- Record updated
- 17 September 2025