NCT06058728

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

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)

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: AbbVie · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Uterine Fibroids (UF)

Timeline

• Start date: 2023-12-20
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2023-09-28
• Last updated: 2025-09-17

Locations

1 site across 1 country: United States