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Clinical Trial Summary

A multicenter, prospective, open-label clinical study will be conducted, to monitor serum concentration and pharmacokinetic profile after subcutaneous implantation of a 25mg absorbable pellet containing estradiol in climacteric women.


Clinical Trial Description

Assessing serum total estradiol concentration and determination of pharmacokinetic parameters will be performed in participants eligible for the study before and after the insertion of estradiol pellet (25 mg) at different collection times [in the first 24 hours, weekly in the first month and monthly until 6 months are complete]. Additionally, the concentration of other hormones influenced by the action of estradiol will be determined (total testosterone, estrone, FSH, LH, SHBG, and prolactin). Medical visits will be carried out for clinical evaluation and follow-up of the participants in the baseline and after 1 month, 3 months, and 6 months. Assessment of the primary outcome will be performed 6 months after estradiol pellet insertion. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06136208
Study type Interventional
Source Science Valley Research Institute
Contact Leandro Agati
Phone +551144688183
Email agati@svriglobal.com
Status Recruiting
Phase N/A
Start date December 13, 2023
Completion date October 30, 2024

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