NCT06136208

Pharmacokinetic Aspects of 25-mg Estradiol Pellet in Climacteric Women

Pharmacokinetic Aspects of 25-mg Estradiol Pellet in Climacteric Women Comprehensive Longitudinal Assessment of Release With Estradiol Pellet Analysis (CLARA Study)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Science Valley Research Institute · Academic / Other
• Sex: Female
• Age: 41 Years – 59 Years
• Healthy volunteers: Accepted

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.

Detailed 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. N=20 participants.

Conditions

• Climacteric Syndrome
• Menopause
• Hypoestrogenism

Interventions

Type	Name	Description
DRUG	s.c 25 mg estradiol pellet	Subcutaneous insertion of 25 mg estradiol pellet.

Timeline

• Start date: 2023-12-13
• Primary completion: 2024-10-09
• Completion: 2025-07-30
• First posted: 2023-11-18
• Last updated: 2025-09-08

Locations

1 site across 1 country: Brazil