NCT05156814

Comparative Study to Evaluate the Efficacy and Safety of the Fixed-dose Combination of Estradiol / Dydrogesterone in Perimenopausal Women

A Prospective, Multicenter, Randomized, Open-label, Comparative Study in Three Parallel Groups to Evaluate the Efficacy and Safety of the Fixed-dose Combination of Estradiol / Dydrogesterone (Femoston® 1 or Femoston® 2, Coated Tablets) and the Combination Therapy of Dydrogesterone (Duphaston®, Coated Tablets) Plus Estradiol (Divigel, Gel for Topical Application, 0.1%) and Monotherapy With Cimicifuga Racemosa Rhizomatum Extract (Klimadynon®) in Perimenopausal Women

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Scientific Research Institute of Public Health, Russian Federation · Academic / Other
• Sex: Female
• Age: 40 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

To obtain new data allowing personalizing continuous hormonal therapy in perimenopausal women in Russia, the following clinical study is going to be conducted in the Russian Federation:

Conditions

• Perimenopausal Disorder
• Hot Flashes

Interventions

Type	Name	Description
DRUG	Femoston® 1, Femoston® 2	Femoston® 1 (1 mg estradiol / 10 mg dydrogesterone), Femoston® 2 (2 mg estradiol / 10 mg dydrogesterone)
DRUG	Duphaston	Duphaston®, 10 mg
DRUG	Klimadynon	Cimicifuga racemosa rhizomatum extract
DRUG	Divigel	Divigel, 0.1%

Timeline

• Start date: 2021-11-29
• Primary completion: 2022-09-01
• Completion: 2023-05-01
• First posted: 2021-12-14
• Last updated: 2022-01-06

Locations

1 site across 1 country: Russia