Abbvie ((ABBV)), Abbvie (($CC:ABBV.CUR)) announced an update on their ongoing clinical study.
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AbbVie is conducting a study titled ‘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).’ The study aims to assess the incidence, timing, and pattern of hair loss in women with heavy menstrual bleeding (HMB) due to uterine fibroids (UF) who are treated with Oriahnn. This research is significant as it addresses a common side effect that could impact patient adherence and satisfaction.
The intervention being tested is Oriahnn, an oral medication approved for managing HMB associated with UF. The study will monitor participants for meaningful hair loss, examining any racial differences in this side effect.
This observational study follows a cohort model with a prospective time perspective. It involves two groups: one receiving Oriahnn for HMB management and another focusing on those experiencing hair loss. The study does not involve random allocation or masking.
The study began on December 20, 2023, and is currently enrolling by invitation. The primary completion and estimated study completion dates are not specified, but the last update was submitted on July 15, 2025. These dates are crucial for tracking the study’s progress and potential impact.
The study’s results could influence AbbVie’s stock performance by affecting Oriahnn’s market perception, especially if hair loss is a significant concern for patients. Competitors in the women’s health sector may also be impacted if the study results lead to changes in prescribing practices or patient preferences.
The study is ongoing, with further details available on the ClinicalTrials portal.