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

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)

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.

Study Overview

• Status: Withdrawn
• Conditions: Uterine Fibroids (UF)

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Arlington, Virginia, United States, 22201-5330
      • Dorsata /ID# 252675

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Women 18 to 50 years old with heavy menstrual bleeding (HMB) due to uterine fibroids (UF).

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants with Meaningful Hair Loss	Meaningful hair loss is defined as patient-reported 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.	Up to Month 24
Time to Onset of Hair Loss	Time from initiation of Oriahnn until patient-reported meaningful hair loss will be assessed.	Up to Month 42
Changes in Patterns of Hair Loss	Based on example description and images of alopecia subtypes, changes in patterns of hair loss are classified as primary pattern of hair loss.	Up to Month 42
Number of Participants with Improvement in Hair Loss	Defined as a report that since the participant has reported hair loss, her hair loss has improved.	Up to Month 42
Number of Participants with Resolution in Hair Loss	Resolution in hair loss is defined as a report that since the patient has reported hair loss, her hair has returned to normal.	Up to Month 42
Time to Resolution in Hair Loss	Time from onset of meaningful hair loss until reported resolution.	Up to Month 42
Number of Participants who Discontinued Oriahnn at Reported Hair Loss	Discontinuations of Oriahnn at or after reported hair loss will be calculated.	Up to Month 42

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: September 22, 2023
• First Submitted That Met QC Criteria: September 22, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Estimated): September 17, 2025
• Last Update Submitted That Met QC Criteria: September 11, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Elagolix; Estradiol; Heavy Menstrual Bleeding (HMB); Oriahnn; Uterine Fibroids (UF); Norethindrone Acetate
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Uterine Diseases; Genital Diseases, Female; Hemorrhage; Neoplasms, Connective and Soft Tissue; Neoplasms, Muscle Tissue; Uterine Hemorrhage; Menstruation Disturbances; Pathological Conditions, Signs and Symptoms; Leiomyoma; Menorrhagia
• Other Study ID Numbers: P20-400

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No