Comparative Study to Evaluate the Efficacy and Safety of the Fixed-dose Combination of Estradiol / Dydrogesterone in Perimenopausal Women
NCT05156814 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2022-01-06
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
- 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%
Sponsors & Collaborators
-
Scientific Research Institute of Public Health, Russian Federation
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Max Age
- 55 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-11-29
- Primary Completion
- 2022-09-30
- Completion
- 2023-05-31
Countries
- Russia
Study Locations
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