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)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 1,600
- 试验地点
- 1
- 主要终点
- Changes in Patterns of Hair Loss
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
- •- 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.
排除标准
- •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)
结局指标
主要结局
Changes in Patterns of Hair Loss
时间窗: Up to Month 42
Based on example description and images of alopecia subtypes, changes in patterns of hair loss are classified as primary pattern of hair loss.
Number of Participants with Improvement in Hair Loss
时间窗: Up to Month 42
Defined as a report that since the participant has reported hair loss, her hair loss has improved.
Number of Participants who Discontinued Oriahnn at Reported Hair Loss
时间窗: Up to Month 42
Discontinuations of Oriahnn at or after reported hair loss will be calculated.
Time to Onset of Hair Loss
时间窗: Up to Month 42
Time from initiation of Oriahnn until patient-reported meaningful hair loss will be assessed.
Time to Resolution in Hair Loss
时间窗: Up to Month 42
Time from onset of meaningful hair loss until reported resolution.
Percentage of Participants with Meaningful Hair Loss
时间窗: Up to Month 24
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.
Number of Participants with Resolution in Hair Loss
时间窗: Up to Month 42
Resolution in hair loss is defined as a report that since the patient has reported hair loss, her hair has returned to normal.
次要结局
未报告次要终点