Pharmakologisches Update gynäkologische Endokrinologie, Reproduktionsmedizin und Kontrazeption

In: Der Gynäkologe · 2014 · vol. 47(7) , pp. 466–471 · doi:10.1007/s00129-013-3283-y · W88623605
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This review covers new drug therapies for menopausal symptoms, endometriosis, fibroids, assisted reproduction, and contraception, evaluating updated treatment standards.

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Material

und Methoden Die Übersicht basiert auf einer Recherche in einschlägigen Suchmaschinen, z. B. Pubmed, Auswertung von EMA(European Medicines Agency)-Daten und Fachinformationen. Ergebnisse Zur Behandlung des Klimakteriums sind insbesondere in den USA östrogenfreie Pharmaka wie SERM (selektive Östrogenrezeptormodulatoren) bereits zugelassen, ebenso SSRI (selektive Serotoninwiederaufnahmeinhibitoren) bei klimakterischen Beschwerden. Ulipristal für die Myomtherapie hat die Indikation für eine operative Intervention verschoben, Dienogest zur hormonellen Behandlung der Endometriose ist bezüglich Schmerzreduktion äquivalent zu GnRH-Analoga. Zur hormonellen Stimulation in der assistierten Reproduktion werden in Kürze mehrere Biosimilars zur Verfügung stehen. Neuartige FSH-Moleküle befinden sich in der Entwicklung. Jaydess® ist ein für 3 Jahre eingesetztes kleines Gestagen-Intrauterinsystem zur Kontrazeption, das grundsätzlich auch für Nulliparae geeignet ist, wenn auch nicht in primärer Indikation. Diskussion Alternativen in der Behandlung des klimakterischen Syndroms sind verfügbar, mit einer neuen Risiko-Nutzen-Bewertung im Vergleich zur herkömmlichen Hormontherapie. Operative Eingriffe bei Endometriose und Myomen sind möglicherweise reduzierbar. Hormonelle Stimulation in der Reproduktionsmedizin kann individuell auf eine größere Vielfalt von Gonadotropinpräparaten abgestimmt werden. Intrauterine Kontrazeption wird auch für Frauen möglich, für die die Einlage von intrauterinen Gestagenspiralen bisher vergleichsweise schwierig war.

Abstract

Background Many new pharmaceuticals have recently been developed for gynecological endocrinology, assisted reproduction techniques (ART) and hormonal contraception, leading to a reevaluation of current treatment concepts.

Objectives

This update provides new data on hormonal treatment of climacteric syndrome, endometriosis, fibroids, hormonal stimulation prior to ART and intrauterine hormonal contraception.

Material and methods

A standard PubMed research has been performed. Furthermore, data from the European Medicines Agency (EMA) and information from pharmaceutical companies were included.

Results

In the USA estrogen-free drugs, such as selective estrogen receptor modulators (SERM) and selective serotonin reuptake inhibitors (SSRI) are registered for treatment of diverse climacteric symptoms. Ulipristal can be used for fibroid treatment, leading to a postponement of surgical interventions with certain indications and dienogest is a potent gestagen for the treatment of endometriosis equivalent to gonadotropin-releasing hormone (GnRH) analogues for pain relief. Biosimilars for controlled ovarian stimulation in ART have been developed and will shortly be introduced into the market. Novel follicle stimulating hormone (FSH) molecules are being developed. Jaydess® is a small device with progestins for intrauterine contraception, allowing contraception for 3 years which is principally suitable even for nulliparae but not in primary indications.

Conclusion

New alternatives in the treatment of climacteric syndrome avoid estrogen administration and might therefore lead to a reevaluation of the risks and benefits of hormonal therapy. Surgical interventions for endometriosis and fibroids will be further reduced. Controlled ovarian hyperstimulation for ART can be planned with a larger variety of gonadotrophin preparations. Small intrauterine devices might open access to this type of hormonal contraception for women with previously difficult insertion of intrauterine devices. Similar content being viewed by others Literatur Arce JC, Rasmussen BB (2013) Vortrag auf dem European Bioanalysis Forum, Barcelona. http://bcn2013.europeanbioanalysisforum.eu/slides/PDF/P1-Med-3%20Joan-Carles%20Arce%20and%20Birgitte%20Buur%20Rasmussen%20.pdf Donnez J, Tatarchuk TT, Bouchard P et al, PEARL I study group (2012) Ulipristal acetate versus placebo for fibroid treatment before surgery. N Engl J Med 366:409–420 Donnez J, Tomaszewski J, Vazquez F et al (2012) Ulipristal acetate versus leuprolide acetate for for uterine fibroids. N Engl J Med 366:421–432 Fachinformation Jaydess®. Stand April 2013 Gemzell-Danielsson K, Schellschmidt I, Apter D (2012) A randomized, phase II study describing the efficacy, bleeding profile, and safety of two low-dose levonorgestrel-releasing intrauterine contraceptive systems and Mirena. Fertil Steril 97:616–622 Glycotope. Presseaussendung der Glycotope GmbH, Berlin, vom 18. November 2013 Goldstein SR, Bachmann GA, Koninckx PR et al (2013) Ospemifene 12-month safety and efficacy in postmenopausal women with vulvar and vaginal atrophy. Climacteric Imthurn B, Rettenbacher M, die Bemfola Studien Gruppe (2013) A phase III assessor-blinded randomised multi-centre study to compare efficacy and safety of two r-hFSH formulations (AFOLIA [Bemfola®] vs Gonal-f®) in women for assisted reproductive treatment. Hum Reprod 28(Suppl 1):i44–i46 Jaydess Phase-III-Studie. Bayer HealthCare Pharmaceuticals Inc. 2011. Data on file Jee BC, Lee JY, Suh CS et al (2009) Impact of GnRH agonist treatment on recurrence of ovarian endometriomas after conservative laparoscopic surgery. Fertil Steril 91:40–45 Kagan R (2012) The tissue selective estrogen complex: a novel approach to the treatment of menopausal symptoms. J Womens Health (Larchmt) 21:975–981 Köhler G, Faustmann TA, Gerlinger C et al (2010) A dose-ranging study to determine the efficacy and safety of 1, 2, and 4 mg of dienogest daily for endometriosis. Int J Gynaecol Obstet 108:21–25 Komi J, Lankinen KS, DeGregorio M et al (2006) Effects of ospemifene and raloxifene on biochemical markers of bone turnover in postmenopausal women. J Bone Miner Metab 24:314–318 Mirkin S, Komm BS (2013) Tissue-selective estrogen complexes for postmenopausal women. Maturitas 76:213–220 Nelson AL, Gemzell-Danielsson K, Borgatta L et al (2012) User satisfaction, ease of placement, and discomfort during placement of two low-dose levonorgestrel contraceptive intrauterine systems (LNG-IUSs) in a multicenter, randomized, phase III study. Poster presentation Am Soc Reprod Med Olsson H, Sandström R, Grundemar L (2013) A randomised, double-blind, active-controlled, multiple-dose trial investigating the pharmacokinetics and pharmacodynamics of a novel recombinant FSH (FE 999049) derived from a human cell line. Hum Reprod 28(suppl 1):i311–i356 Petraglia F, Hornung D, Seitz C et al (2012) Reduced pelvic pain in women with endometriosis: efficacy of long-term dienogest treatment. Arch Gynecol Obstet 285:167–173 Pinkerton JV, Abraham L, Bushmakin AG et al (2014) Evaluation of the efficacy and safety of bazedoxifene/conjugated estrogens for secondary outcomes including vasomotor symptoms in postmenopausal women by years since menopause in the Selective Estrogens, Menopause and Response to Therapy (SMART) Trials. J Womens Health (Larchmt) 23:18–28 Portman DJ, Bachmann GA, Simon JA, Ospemifene Study Group (2013) Ospemifene, a novel selective estrogen receptor modulator for treating dyspareunia associated with postmenopausal vulvar and vaginal atrophy. Menopause 20:623–630 Sandström R, Olsson H, Grundemar L (2013) Different pharmacokinetic properties between a novel recombinant FSH (FE 999049) derived from a human cell line and follitropin alfa. Hum Reprod 28(suppl 1):i311–i356 Simon JA, Lin VH, Radovich C et al (2013) One-year long-term safety extension study of ospemifene for the treatment of vulvar and vaginal atrophy in postmenopausal women with a uterus. Menopause 20:418–427 Simon J, Portman D, Mabey RG Jr, the Ospemifene Study Group (2013) Long-term safety of ospemifene (52-week extension) in the treatment of vulvar and vaginal atrophy in hysterectomized postmenopausal women. Maturitas 17 pii:S0378–5122(13)00377-0 Simon JA, Portman DJ, Kaunitz AM et al (2013) Low-dose paroxetine 7.5 mg for menopausal vasomotor symptoms: two randomized controlled trials. Menopause 20:1027–1035 Soe LH, Wurz GT, Kao CJ et al (2013) Ospemifene for the treatment of dyspareunia associated with vulvar and vaginal atrophy: potential benefits in bone and breast. Int J Womens Health 25:605–611 Strowitzki T, Faustmann A, Christoph G et al (2010) Dienogest in the treatment of endometriosis-associated pelvic pain: a 12-week, randomized, double-blind, placebo-controlled study. Eur J Obstet Gynecol Reprod Biol 151:193–198 Strowitzki T, Marr J, Gerlinger C et al (2010) Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial. Hum Reprod 25:633–641 Vercellini P, Somigliana E, Viganò P et al (2009) Endometriosis: current therapies and new pharmacological developments. Drugs 69:649–675 Einhaltung ethischer Richtlinien Interessenkonflikt. T. Strowitzki gibt für sich und seine Koautoren an, dass kein Interessenkonflikt besteht. T. Strowitzki: Lecturer für Barr Health Care für Dienogest, LKP für deutsche Dienogeststudien. Dieser Beitrag beinhaltet keine Studien an Menschen oder Tieren. Author information Authors and Affiliations Corresponding author Rights and permissions About this article Cite this article Strowitzki, T., Griesinger, G. & Rabe, T. Pharmakologisches Update gynäkologische Endokrinologie, Reproduktionsmedizin und Kontrazeption. Gynäkologe 47, 466–471 (2014). https://doi.org/10.1007/s00129-013-3283-y Published: Issue date: DOI: https://doi.org/10.1007/s00129-013-3283-y

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