Changes in the clinical symptoms of fibrocystic mastopathy during monotherapy with transdermal micronized progesterone: results of the BREAST-2 multicenter open prospective cohort study

Protasova A.E.

Saint Petersburg State University, Saint Petersburg, Russia; I.I. Mechnikov North-Western State Medical University, Saint-Petersburg, Russia; V.A. Almazov National Medical Research Center, Saint Petersburg, Russia
Objective. To investigate the efficiency and safety of monotherapy with the transdermal micronized progesterone Progestogel for diffuse fibrocystic mastopathy. Materials and methods. The observational study enrolled 722 patients aged 37.1±0.3 years with preserved menstrual function and diagnosed diffuse fibrocystic mastopathy. The observation period consisted of a continuous medication usage period about 3 months (3 cycles), or, if necessary, a second course of as many as 6 months (6 cycles). The main criterion for the efficiency of the therapy was to estimate the number of masses, as evidenced by ultrasonography. During the study, the investigators made breast ultrasound and radiographic examinations, Breast Imaging-Reporting and Data System (BI-RADS) assessment, recorded pain intensity with a visual analogue scale (VAS), and assessed a patient’s health status according to the Clinical Global Impression Scale (CGI). Results. The clinical breast assessment throughout the investigation, by using the main efficiency criterion showed a decrease in the average number of masses in one patient during the treatment: 5.09±0.15 (before treatment), 2.97±0.13 (after 3-month therapy), and 2.29±0.16 (after 6-month therapy), (p < 0.001). There was a significant reduction in the signs of the disease, as assessed by ultrasonography of mass sizes (p <0.001). The changes in the breast detected by its clinical examination and mammography showed statistically significantly better BI-RADS scores (p < 0.001). Pain syndrome intensity assessment using the VAS demonstrated a significant decrease: 47.5±0.8 (before treatment), 13.5±0.6 (following 3 months), and 7.7 ± 0.8 (following 6 months) (p <0.001). Conclusion. The investigation provided evidence for the sufficient efficacy and safety profile of Progestogel monotherapy for fibrocystic mastopathy.


fibrocystic mastopathy
micronized progesterone


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Received 31.07.2020

Accepted 18.08.2020

About the Authors

Anna E. Protasova, MD, Professor of the Department of oncology, Faculty of medicine, Saint Petersburg State University; Professor of the Department of obstetrics and gynecology, V. A. Almazov National Medical Research Center Ministry of Health of Russia; Professor of the Department of oncology, I.I. Mechnikov North-Western State Medical University Ministry of Health of Russia; Head of the Department of oncology, AVA-PETER LLC. Tel.: +7(921)919-84-24. E-mail:
7-9 Universitetskaya nab., Saint Petersburg, 199034, Russia; 2 Akkuratova str., Saint Petersburg, 197341, Russia; 41 Kirochnaya str., Saint Petersburg,
191015, Russia; 22-24 lit. A pom. 50-N, Nevsky Ave., Saint Petersburg, 191186, Russia.

For citation: Protasova A.E. Changes in the clinical symptoms of fibrocystic mastopathy during monotherapy with transdermal micronized progesterone: results of the BREAST-2 multicenter open prospective cohort study.
Akusherstvo i Ginekologiya/ Obstetrics and Gynecology. 2020; 8: 159-168 (in Russian).

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