NCT05737329

Efficacy, Safety, and Tolerability of Higher Doses Estrogen Therapy in Women With Premature Ovarian Insufficiency

Optimization of Management Tactics for Women With Premature Ovarian Insufficiency, Taking Into Account Their Clinical and Hormonal Profile

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare · Other Government
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to assess the effects of higher doses versus standard hormone therapy on quality of life (QoL), symptoms due to estrogen deficiency, and bone health in women with premature ovarian insufficiency (POI). The efficacy of the hormonal treatment will be assessed clinically and also by measuring serum concentrations of Estradiol (E2), Follicle-Stimulating Hormone (FSH), Luteinizing hormone (LH), total Testosterone (T), Estrone (E1), E1 sulfate (E1S), and Sex Hormone Binding Globulin (SHBG). Bone mineral density (BMD) will be measured using dual-energy X-ray absorptiometry. Safety will be assessed by measuring endometrial thickness with Gynecological transvaginal ultrasound (TVS), treatment-related adverse events (AEs) and treatment-emergent AEs monitoring.

Conditions

• Primary Ovarian Insufficiency

Interventions

Type	Name	Description
DRUG	Transdermal estradiol gel 0.1% 1.5mg/ day	Estradiol gel 0.1% 1.5mg/ daily + Micronized Progesterone 200mg
DRUG	Transdermal estradiol gel 0.1% 2.0mg/ day	Estradiol gel 0.1% 2.0mg/ daily + Micronized Progesterone 200mg

Timeline

• Start date: 2019-03-01
• Primary completion: 2023-04-01
• Completion: 2023-04-01
• First posted: 2023-02-21
• Last updated: 2023-02-28

Locations

1 site across 1 country: Russia