Bayer AG ((BAYRY)), Bayer Ag (UK) ((GB:0P6S)) announced an update on their ongoing clinical study.
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Study Overview: Bayer AG is conducting a study titled A Multi-center, Open Label, Randomized Parallel Group Study Evaluating the Proportion of Post-menarchal Women With Complete Resolution of Nonatypical Endometrial Hyperplasia Treated With Mirena or Oral Progestin for 6 Months. The study aims to compare the effectiveness of Mirena, an intrauterine device, against oral progestin in resolving nonatypical endometrial hyperplasia (NAEH), a non-cancerous thickening of the uterine lining, in women who have started menstruating. This research is significant as it seeks to address unmet treatment needs for NAEH, which can lead to cancer if untreated.
Intervention/Treatment: The study tests two interventions: Mirena (BAY 865028), an intrauterine device that releases progesterone, and oral progestin (Medroxyprogesterone acetate), a daily oral tablet. Both aim to balance hormone levels and treat NAEH.
Study Design: This Phase 3 interventional study is randomized with a parallel assignment. Participants will be divided into two groups: one receiving Mirena and the other oral progestin. The study is open-label, meaning no masking is involved, and its primary purpose is treatment.
Study Timeline: The study is set to begin on September 5, 2025, with an estimated primary completion date six months later. The study was first submitted on March 21, 2025, and last updated on August 5, 2025. These dates are crucial for tracking the study’s progress and anticipated results.
Market Implications: Bayer’s study could impact its stock performance positively if Mirena proves more effective than oral progestin, potentially increasing its market share in women’s health treatments. Competitors in the hormonal treatment market may face increased pressure to innovate or adjust strategies based on the study’s outcomes.
The study is ongoing, with further details available on the ClinicalTrials portal.