ArticleMenopause (New York, N.Y.)2026
Pharmacokinetic analysis of 25 mg estradiol subcutaneous bioabsorbable implant in postmenopausal women (CLARA STUDY).
Article in Menopause (New York, N.Y.), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
objectiveTo investigate the pharmacokinetic profile of estradiol delivery after the subcutaneous insertion of a 25 mg estradiol bioabsorbable implant in hysterectomized women presenting with menopause-associated symptoms.
methodsThis was a prospective, open-label, single-arm study conducted at a single center between December 2023 and October 2024. Twenty hysterectomized participants received a 25 mg subcutaneous estradiol implant and were followed at weeks 4, 12, and 24 for clinical assessments, symptom evaluation, and safety monitoring. Hormone levels were measured using liquid chromatography-tandem mass spectrometry and electrochemiluminescence immunoassay. Adverse events were recorded, and menopause symptoms were assessed using the Menopause Rating Scale (MRS).
resultsSerum estradiol levels increased after treatment, rising from 31.6±7.0 pg/mL preinsertion to 105.2±10.7 pg/mL (mean±SD) at week 1, remaining stable (~80 pg/mL) through Week 20 and above pre-insertion levels until week 24. Estrone had a similar profile. Follicle-stimulating hormone and luteinizing hormone levels decreased throughout the treatment. Sex hormone-binding globulin, total and free testosterone, and prolactin showed minimal variation throughout the study. Subcutaneous estradiol delivery resulted in a sustained pharmacokinetic profile characterized by a Tmax of 75.6 hours and a 6439 hours notably extended half-life (T1/2). Vasomotor and psychological symptoms decreased significantly after 4 weeks of treatment, and the reduction in Menopause Rating Scale score was observed until Week 24. No serious adverse event was reported.
conclusionThe 25 mg estradiol implant provided sustained serum concentration of estradiol over a 24-week period of treatment, effective symptom relief, and an acceptable safety profile in hysterectomized women, thereby offering a novel therapeutic option for hormone therapy.
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