Терапия дидрогестероном для нормализации менструального цикла в рутинной клинической практике многоцентровое наблюдательное исследование

Н. М. Подзолкова; Т. Ф Татарчук; А. М. Дощанова; Г. З. Ешимбетова; К. Пексман-Фейс

doi:10.18370/2309-4117.2016.32.8-13

Authors

Н. М. Подзолкова Russian Medical Academy of Postgraduate Education of the MOH of Russian Federation, Russian Federation
Т. Ф Татарчук SI “Institute of Pediatrics, Obstetrics and Gynecology of the NAMS of Ukraine”, Ukraine https://orcid.org/0000-0002-5498-4143
А. М. Дощанова MOH of Kazakhstan, Astana, Kazakhstan
Г. З. Ешимбетова Tashkent Institute of Postgraduate Medical Education, Uzbekistan
К. Пексман-Фейс Abbott GmbH & Co. KG , Ludwigshafen, Germany https://orcid.org/0000-0002-9181-9913

DOI:

https://doi.org/10.18370/2309-4117.2016.32.8-13

Keywords:

abnormal uterine bleeding, dydrogesterone, menstrual-cycle regularization, quality of life

Abstract

Dydrogesterone is an oral retroprogesterone widely used to treat progesterone deficiencies, including irregular menstrual cycles. This prospective, non-interventional, single-arm, post-marketing, observational study evaluated the effects of dydrogesterone on menstrual cycle regularization. Women aged 18-40 years who had been prescribed dydrogesterone to treat irregular menstrual cycles due to progesterone deficiency were enrolled across 64 centers in Russia, Ukraine, Kazakhstan and Uzbekistan.

Study objectives included: patients reporting ≥ 1 regular menstrual cycle during treatment; the number of regular menstrual cycles after the end of treatment over a 6-month follow-up period. In total, 996 women were enrolled. Of those who completed treatment, 946 (99.1%) of 955 patients achieved ≥ 1 regular menstrual cycle. During follow-up period, 680 (79.1%) of 860 patients maintained ≥ 6 regular menstrual cycles.Patient grading of menstrual pain and anxiety decreased significantly during treatment (p ≤ 0.0001 versus baseline); this persisted during follow-up period.

Dydrogesterone was associated with high or very high patient satisfaction – 856 (89.6%) of 955 women; the clinical response was considered good or excellent in 819 (85.8%) of 955 patients. This is comparable with the results of previous studies and confirms once again that the efficacy of treatment of abnormal uterine bleedings with dydrogesterone is highly appreciated by patients and physicians in routine clinical practice.

In total, 16 (1.6%) of 986 patients reported an adverse event; two had serious adverse events (unrelated to treatment) and three discontinued treatment due to non-serious adverse events.

Dydrogesterone therapy was effective in achieving menstrual cycle regularization and reducing menstrual pain and anxiety, during both treatment and 6-month follow-up period.

Author Biographies

Н. М. Подзолкова, Russian Medical Academy of Postgraduate Education of the MOH of Russian Federation

MD, professor, head of Obstetrics and Gynecology Department

Т. Ф Татарчук, SI “Institute of Pediatrics, Obstetrics and Gynecology of the NAMS of Ukraine”

MD, professor, corresponding member of the NAMS of Ukraine, deputy director for research work, сhief of the Endocrine Gynecology Department

А. М. Дощанова, MOH of Kazakhstan, Astana

MD, professor, chief specialist in Gynecology and Endocrinology

Г. З. Ешимбетова, Tashkent Institute of Postgraduate Medical Education

MD, professor at the Obstetrics, Gynecology and Perinatale Medicine Department

References

Ely, J.W., Kennedy, C.M., Clark, E.C., Bowdler, N.C. “Abnormal uterine bleeding: a management algorithm.” J Am Board Fam Med 19 (2006): 590–602.
Marret, H., Fauconnier, A., Chabbert-Buffet, N., et al. “Clinical practice guidelines on menorrhagia: management of abnormal uterine bleeding before menopause.” Eur J Obstet Gynecol Reprod Biol 152 (2010): 133–7.
Matteson, K.A., Raker, C.A., Clark, M.A., Frick, K.D. “Abnormal uterine bleeding, health status, and usual source of medical care: analyses using the Medical Expenditures Panel Survey.” J Womens Health (Larchmt) 22 (2013): 959–65.
Schindler, A.E., Campagnoli, C., Druckmann, R., et al. “Classification and pharmacology of progestins.” Maturitas 46 (2003): 7–16.
Anklesaria, B., Balamba, P., Banerjee, B., et al. “Cycle regularization with dydrogesterone in Indian women.” Obstet Gynaecol 4 (1999): 559–64.
Panay, N., Pritsch, M., Alt, J.
“Cyclical dydrogesterone in secondary amenorrhea: results of a double-blind, placebo-controlled, randomized study.” Gynecol Endocrinol 23 (2007): 611–8.
Schindler, A.E. “Progestational effects of dydrogesterone in vitro, in vivo and on the human endometrium.” Maturitas 65 (2009): 3–11.
Carp, H. “A systematic review of dydrogesterone for the treatment of threatened miscarriage.” Gynecol Endocrinol 28 (2012): 983–90.
Carp, H. “A systematic review of dydrogesterone for the treatment of recurrent miscarriage.” Gynecol Endocrinol 31 (2015): 422–30.
Patki, A., Pawar, V.C. “Modulating fertility outcome in assisted reproductive technologies by the use of dydrogesterone.” Gynecol Endocrinol 23 (2007): 68–72.
Tabaste, J.L., Servaud, M., Steiner, E., et al. “Action of dydrogesterone in postpubertal menstruation disorders.” Rev Fr Gynecol Obstet 79 (1984): 19–25.
Saldanha, E.F., Tank, D.K., Chainani, M.S. “Dydrogesterone in the management of dysfunctional uterine bleeding.” Int J Gynecol Obstet India 1 (1997): 36–9.
Naib, J.M., Siddiqui, M.I., Ajmal, W. “The role of dydrogesterone in the medical management of 100 cases of dysfunctional uterine bleeding (DUB) above 35 years of age.” J Postgrad Med Inst (Peshawar) 17 (2003): 189–93.
Duphaston in cycle regularization: a postmarketing, prospective, multicenter, observational study. Available from [https://clinicaltrials.gov/ct2/show/study/NCT01525563?sect¼Xb0156], last accessed Nov 26, 2016.
World Medical Association (WMA) Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects (2013). Available from [http://www.wma.net/en/30publications/10policies/b3/index.html], last accessed Nov 26, 2016.