Abbvie ((ABBV)), Abbvie (($CC:ABBV.CUR)) announced an update on their ongoing clinical study.
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AbbVie recently completed a Phase 3b study titled ‘A Phase 3b Study to Evaluate the Long-Term Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women.’ The study aimed to assess the long-term safety of elagolix combined with estradiol/norethindrone acetate in managing heavy menstrual bleeding due to uterine fibroids, a condition affecting many premenopausal women.
The study tested the combination of elagolix, a drug, with estradiol/norethindrone acetate, designed to manage heavy menstrual bleeding. The intervention involved administering elagolix 300 mg twice daily with estradiol/norethindrone acetate once daily.
This randomized, multicenter study followed a parallel intervention model with quadruple masking, ensuring that participants, care providers, investigators, and outcomes assessors were blinded. The primary purpose was treatment-focused, with a double-blind phase for the first 12 months followed by an open-label phase for the next 36 months.
The study began on September 13, 2017, and reached primary completion in June 2025, with the last update submitted in July 2025. These dates are crucial as they mark the progression and finalization of the study, providing a timeline for data availability and analysis.
The completion of this study could influence AbbVie’s stock performance positively, as successful results may enhance investor confidence and market position. It also places AbbVie in a competitive stance within the pharmaceutical industry, particularly in women’s health treatments.
The study has been completed, with further details available on the ClinicalTrials portal.