Pharmacokinetic Aspects of 25-mg Estradiol Pellet in Climacteric Women
NCT06136208 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2025-09-08
Summary
A single center, prospective, open-label clinical study will be conducted, to monitor serum concentration and pharmacokinetic profile after subcutaneous implantation of a 25mg-estradiol bioabsorbable implant in postmenopausal women.
Conditions
- Climacteric Syndrome
- Menopause
- Hypoestrogenism
Interventions
- DRUG
-
s.c 25 mg estradiol pellet
Subcutaneous insertion of 25 mg estradiol pellet.
Sponsors & Collaborators
-
Biòs Farmacêutica
collaborator UNKNOWN -
Science Valley Research Institute
lead OTHER
Principal Investigators
-
André Luiz Malavasi de Oliveira Longo, MD, PhD · Science Valley Research Institute
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 41 Years
- Max Age
- 59 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-12-13
- Primary Completion
- 2024-10-09
- Completion
- 2025-07-30
Countries
- Brazil
Study Locations
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