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 Type
OBSERVATIONAL
Dorsata /ID# 252675
Arlington, Virginia, United States
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.
Time frame: Up to Month 24
Time to Onset of Hair Loss
Time from initiation of Oriahnn until patient-reported meaningful hair loss will be assessed.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to Month 42
Time to Resolution in Hair Loss
Time from onset of meaningful hair loss until reported resolution.
Time frame: 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.
Time frame: Up to Month 42
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