Academic literature on the topic 'Dydrogesteron'

The study was earned out to investigate effect of Progesterone 's agonist Dydrogesterone in the treatment оf the miscarriage. Thus, it was seen that Dydrogesterone 's treatment (10 mg/daily per os) zvas more effective than Progesterone for prophylactic miscarriage.

ZusammenfassungFrauen mit intaktem Uterus müssen bei der Anwendung eines systemisch wirksamen Östrogens zur Endometriumprotektion ein Gestagen erhalten. Gestagene lassen sich in verschiedene Wirkstoffgruppen einteilen, welche unterschiedliche Partialwirkungen haben. Dies bedeutet, dass es keinen Klasseneffekt der Gestagene gibt, sondern die Effekte auf Metabolismus sowie auf hormonsensible Gewebe wie Brust, Endometrium und Knochen variieren können. Mikronisiertes Progesteron und Dydrogesteron scheinen in Hinblick auf Herz-Kreislauf-System und Brust die sicherste Option zu sein. Ihre Effekte auf die Glukosehomöostase und den Lipidstoffwechsel sind neutral. Eine menopausale Hormontherapie, einschliesslich der Wahl des Gestagens, sollte immer entsprechend dem Risikoprofil und den Behandlungszielen der Patientin individualisiert werden.

Zusammenfassung. Die primäre Indikation für die Verwendung von Gestagenen in der MHT ist die Vermeidung eines estrogen-bedingten Risikos für ein Endometriumkarzinom. Progesteron hat die geringste endometriale Effektivität, wird jedoch zunehmend (zusammen mit transdermalem Estradiol) eingesetzt, wegen vaskulärer und metabolischer Neutralität und möglicherweise einem geringeren Brustkrebsrisiko. Diesbezüglich weitgehend vergleichbar ist Dydrogesteron, Retroisomer des Progesteron, jedoch mit stärkerer endometrialer Wirksamkeit. Es werden jedoch auch andere Gestagene (inklusive Tibolon) eingesetzt, um androgene, anti-androgene und anti-mineralokortikoide «Partialwirkungen» auszunutzen. Auf Basis der «Women’s Health Initiative»-Studie muss durch die Gestagenkomponente mit einem erhöhten Risiko für Brustkrebs und koronare Herzerkrankungen gerechnet werden. In Beobachtungsstudien wird dies für unterschiedliche Gestagene bestätigt, möglicherweise auch ein durch Gestagen erhöhtes Insultrisiko. Gestagen-bedingte kardiovaskuläre Risiken lassen sich durch einen frühen Behandlungsbeginn mit jeder Form der MHT reduzieren, beziehungsweise kann sogar mit einer Prävention gerechnet werden. Bleibt als wichtigstes Risiko das Brustkrebsrisiko. Da sich dieses mit keiner Form einer MHT ausschliessen lässt, wird vorgeschlagen, künftig ein Screening hinsichtlich bekannter Mechanismen der hormonbedingten Brustkrebsentstehung durchzuführen, zumindest für Patientinnen mit erhöhtem Risiko. Dazu werden neue eigene Forschungsergebnisse beschrieben.

Zusammenfassung. Postmenopausale Frauen leiden zusätzlich zu klimakterischen Beschwerden oft an internistischen Krankheiten. In diesen Fällen ist es wichtig zu wissen, wann, in welcher Form und in welcher Dosis eine menopausale Hormontherapie (MHT) verordnet werden darf und in welchen Situationen sie kontraindiziert ist. Zur Verminderung des Risikos einer MHT bei internistischen Grundkrankheiten gelten folgende Grundregeln: Sofern keine Kontraindikationen bestehen, soll die MHT innerhalb des «günstigen Fensters» begonnen werden (in einem Alter < 60 Jahren bzw. innerhalb von 10 Jahren ab Menopause). Zu bevorzugen ist eine kontinuierliche transdermale MHT. Ein First-Pass-Effekt ist bei den meisten internistischen Krankheiten unerwünscht. Zudem sollten zyklische Schwankungen der Serumspiegel vermieden und die niedrigste wirksame Dosis verwendet werden: praktisch alle bekannten Nebenwirkungen der MHT sind dosisabhängig. Metabolisch neutrale Gestagene, wie Progesteron, Dydrogesteron und Dienogest, oder transdermales Norethisteron-Azetat (NETA) sind zu bevorzugen, Medroxyprogesteron-Azetat ist hingegen zu vermeiden. Bei Unklarheiten muss das weitere Vorgehen mit dem zuständigen Internisten abgesprochen werden. Angiopathien, z. B. bei Hypertonie, systemischem Lupus erythematodes oder Diabetes mellitus, sind eine absolute Kontraindikation gegen eine MHT. Liegen keine Angiopathien vor, so ist bei diesen Erkrankungen oft eine transdermale MHT nach genauer Nutzen-Risiko-Evaluation und Rücksprache mit dem behandelnden Arzt vertretbar.

Background: There is limited data about the knowledge, perception, and routine clinical usage pattern of dydrogesterone among medical practitioners in India. Therefore, the present survey was undertaken to assess attitudes and perception/practices of obstetrician and gynaecologists towards use of dydrogesterone in the real-life setting.Methods: Total 1168 gynaecologists across India participated in the KAP survey. Sixteen questions which explored indications, dosages, duration, efficacy, tolerability and comparison were asked and results were expressed as percentages.Results: Dydrogesterone has been marketed since the 1960s and has been extensively used worldwide for the treatment of threatened miscarriage (TM) and recurrent miscarriage (RM). Dydrogesterone is approved for hormone replacement therapy (HRT), as well as pregnancy and non-pregnancy-related conditions where there is a progesterone deficiency. In the present survey, dydrogesterone 10 mg twice daily was found to be the most commonly preferred dosage by 823 (73%) gynaecologists. Poor tolerability, compliance and lower efficacy were reported as major limitations of micronized progesterone by 68% of doctors. The average clinical pregnancy rate noted at 12 weeks after Dydrogesterone usage was around 40% by majority of the doctors. However, 30% of doctors noted more than 40% of clinical pregnancy rate after dydrogesterone usage. Almost 35% of doctors reported that the average live birth rate noticed after dydrogesterone usage is around 40%.Conclusions: The present KAP survey highlights that the effectiveness and the tolerability of dydrogesterone is valued by Indian gynaecologists which accounts for its robust clinical utility.

Objective. To justify the selection of the most effective gestagen with an optimal safety profile in the treatment of patients with pregnancy loss. Patients and methods. A retrospective study of 93 records of patients with recurrent pregnancy loss (RPL) who were prescribed gestagens was made. The first group included 49 patients taking dydrogesterone; the second – 44 patients who received micronized progesterone (19 – orally/subgroup 2a/ and 25 – intravaginally/subgroup 2b/). In order to assess the effectiveness of therapy, prolongation of pregnancy up to 22 weeks was the study’s primary endpoint. The secondary endpoint was prolongation of pregnancy up to 34 weeks of gestation and live birth. Results. A positive subjective evaluation was found in 94% of women taking dydrogesterone and in 79.5% of women taking micronized progesterone (68.4% – orally and 88% – intravaginally). The total number of observations with adverse effects when taking dydrogesterone was significantly lower than in case of micronized progesterone: in 7 (16%) and 31 (72%), respectively (p < 0.05). Dull lower abdominal pain was significantly more frequent in oral administration of micronized progesterone compared with dydrogesterone: in 15 (79%) and 11 (22%), respectively (p < 0.05). In dydrogesterone and intravaginal administration of micronized progesterone, pain syndrome occurred with the same frequency. Bloody vaginal discharge was 2.5 times more frequent in group 2: in 4 (8%) patients of group 1 and in 10 (23%) patients in group 2 (p < 0.05). Moreover, bloody discharge remained significantly more often in case of vaginal administration of micronized progesterone (p < 0.05). In oral micronized progesterone, the difference with dydrogesterone was not significant. According to ultrasound data, hematomas that were not accompanied by bloody discharge were registered in 6 (12%) patients taking micronized progesterone, equally for oral and intravaginal administration. Against the background of receiving dydrogesterone, no hematomas were revealed according to ultrasound data. Against the administration of dydrogesterone, both primary and secondary results were achieved in all women. With the use of micronized progesterone, the primary result was achieved in 39 (88.6%), the secondary – in 38 (86%) patients. Early pregnancy loss was in 6 (14%) women of group 2: 5 (11%) had a spontaneous miscarriage before 14 weeks of gestation (intravaginal drug administration), one had premature birth at 32 weeks (oral drug administration). Conclusion. Dydrogesterone has the highest efficacy and optimal safety profile in the treatment of RPL; therefore, it can be considered as the gestagen of choice in early pregnancy. If it is impossible to prescribe dydrogesterone, preference should be given to micronized progesterone – intravaginal route of administration. Key words: dydrogesterone, micronized progesterone, pregnancy loss, progesterone

The aim of the study was to determine the endometrial safety of oral 17/3- oestradiol combined continuously with dydrogesterone in preventing endometrial proliferation. The low dose group comprised three 52-week (13 cycles of 28 days) studies (two of which were double blind) using a 17ft- о estradiol dose of 1 mg daily combined with dydrogesterone 2,5; 5; 10 or 20 mg daily. The high dose group comprised two 24-week double-blind studies using a 17ft-oestradiol dose of 2 mg daily combined with dydrogesterone 2,5; 5; 10 or 15 mg daily. Endometrial safety was verified by aspiration endometrial biopsies. Inadequate progestational response was defined as proliferative endometrium, endometrial polyp, hyperplasia and carcinoma. Endometrial protection was achieved with dydrogesterone at doses of 5 mg or higher combined with 1 or 2 mg 17^-oestradiol. So, 5 mg daily dydrogesterone appears to be the lowest effective dose to ensure endometrial safety in a continuous combined regimen with 1 or 2 mg 17p-oestradiol.

Justificativa: Há evidências de que o uso de progesterona para suporte de fase lútea melhora os resultados reprodutivos em mulheres submetidas a técnicas de reprodução assistida (TRA). Há várias hipóteses para justificar a deficiência de fase lútea após a estimulação ovariana controlada (EOC) para TRA. Atualmente, acredita-se que os níveis supra-fisiológicos de esteroides alcançados durante a EOC persistem após a aspiração folicular, graças à formação de múltiplos corpos lúteos. Dessa forma, ocorre um feedback negativo prematuro na secreção de hormônio luteinizante (LH), causando um defeito da fase lútea e baixos níveis de progesterona. A progesterona natural por via intramuscular ou vaginal apresenta efeitos comparáveis sobre os parâmetros de gravidez clínica e gravidez em curso, embora as pacientes possam apresentar vários efeitos colaterais, como dor e abscesso local com a progesterona intramuscular, e corrimento vaginal, irritação perineal e interferência com o coito com a progesterona vaginal. Desta forma, a didrogesterona, uma progesterona sintética com boa biodisponibilidade oral, vem sendo estudada como uma alternativa para suporte de fase lútea em mulheres submetidas à TRA. Objetivo: Comparar a didrogesterona oral com a progesterona vaginal como suporte de fase lútea em ciclos de reprodução assistida. Métodos de busca: As buscas por ensaios clínicos randomizados (ECRs) foram realizadas nos principais bancos eletrônicos de dados; além disso, examinamos manualmente as listas de referências dos estudos incluídos em revisões semelhantes. A última busca eletrônica foi feita em 18 de outubro de 2015. Critérios de Seleção: Apenas estudos verdadeiramente randomizados que comparassem o uso da didrogesterona com a progesterona como suporte de fase lútea foram considerados elegíveis. Os estudos que permitiam a inclusão de uma mesma paciente duas vezes foram incluídos apenas se os dados do primeiro ciclo estivessem disponíveis. Coleta e Análise de Dados: Dois revisores avaliaram, independentemente, a elegibilidade dos estudos, extração de dados e os riscos de vieses dos estudos incluídos. Quaisquer discordâncias foram resolvidas por consenso. Quando necessário, os autores dos estudos incluídos foram contatados para maiores informações. Resultados: A busca selecionou 343 registros, 8 dos quais eram elegíveis. Nenhum estudo relatou nascidos vivos. Não há diferença relevante entre didrogesterona oral e progesterona vaginal para gravidez em curso, (RR 1.04, IC 95% 0.92 a 1.18, I² = 0%, p = 0.53, 7 ECRs, 3,134 mulheres), gravidez clínica (RR 1.07, IC 95% 0.93 a 1.23, I² = 34%, p = 0.35, 8 ECRs, 3,809 mulheres), e para abortamento (RR 0.77, IC 95% 0.53 a 1.10, I² = 0%, p = 0.15, 7 ECRs, 906 gestações clínicas). Três estudos reportaram o grau de insatisfação com o tratamento. Dois deles mostraram uma redução importante na insatisfação entre as mulheres que utilizaram didrogesterona em comparação com a progesterona vaginal: didrogesterona oral = 2/79 (2.5%) vs. progesterona vaginal em cápsulas = 90/351 (25.6%), e didrogesterona oral = 19/411 (4.6%) vs. progesterona vaginal em gel = 74/411 (18.0%); o outro estudo não mostrou diferença na taxa de insatisfação: didrogesterona oral = 8/96 (8.3%) vs. progesterona vaginal em cápsulas = 8/114 (7.0%). Conclusão: As evidências atuais sugerem que o uso de didrogesterona oral é tão eficaz quanto a progesterona vaginal como suporte de fase lútea em ciclos de reprodução assistida. Em relação ao grau de satisfação com o tratamento, a didrogesterona oral parece causar menos insatisfação entre as pacientes, em comparação ao uso de progesterona vaginal.
Background: There is evidence that using progesterone for LPS improves the reproductive outcomes in women undergoing ART. There are several hypotheses to justify the lutheal phase deficiency (LPD) after controlled ovarian stimulation (COS) for ART. Currently, it is believed that the supra-physiological levels of steroids achieved during COS and sustained after oocyte aspiration by the multiple corpora lutea causes a prematurely negative feedback in pituitary LH secretion, consequently causing a luteal phase defect and low progesterone levels. Both intramuscular and vaginal routes of natural progesterone exhibit comparable effect on the endpoints of clinical pregnancy and ongoing pregnancy, although patients may exhibit multiple side effects, such as pain and local abscess with intramuscular progesterone, and vaginal discharge, perineal irritation and interference with coitus with vaginal progesterone. In this way, dydrogesterone, a synthetic progesterone with good oral availability, has being studied as an alternative for LPS in women undergoing ART. Objectives: To compare dydrogesterone and progesterone for luteal-phase support in women undergoing assisted reproduction technique. Search methods: The searches for randomized controlled trials (RCT) were performed in the main electronic databases; in addition, we handsearched the reference lists of included studies and similar reviews. We performed the last electronic search on October 18, 2015. Selection criteria: Only truly randomized controlled trials comparing oral dydrogesterone to vaginal progesterone as luteal phase support were considered eligible. We included studies that permitted the inclusion of the same participant more than once (cross-over or \'per cycle\' trials) only if data regarding the first treatment of each participant were available. Data collection and analysis: Two reviewers independently performed study eligibility, data extraction, and assessment of the risk of bias and we solved disagreements by consensus. We corresponded with study investigators in order to resolve any queries, as required. Results: The search retrieved 353 records; eight studies were eligible. No study reported live birth. There is evidence of no relevant difference between oral dydrogesterone and vaginal progesterone on ongoing pregnancy (RR 1.04, 95% CI 0.92 to 1.18, I² = 0%, 7 RCTs, 3,134 women), on clinical pregnancy (RR 1.07, 95% CI 0.93 to 1.23, I² = 34%, 8 RCTs, 3,809 women), and on miscarriage (RR 0.77, 95% CI 0.53 to 1.10, I² = 0%, 7 RCTs, 906 clinical pregnancies). Three studies reported dissatisfaction rate with the treatment. Two of them reported a large reduction in dissatisfaction among women using oral dydrogesterone than among women using vaginal progesterone: oral dydrogesterone = 2/79 (2.5%) vs. vaginal progesterone capsules = 90/351 (25.6%), and oral dydrogesterone = 19/411 (4.6%) vs. vaginal progesterone gel = 74/411 (18.0%). The other included study showed no difference in the dissatisfaction rate: oral dydrogesterone = 8/96 (8.3%) vs. vaginal progesterone capsules = 8/114 (7.0%). Authors\' conclusions: Oral dydrogesterone is as effective as vaginal progesterone for luteal-phase supplementation in ART cycles. Regarding dissatisfaction with treatment, oral dydrogesterone seems to cause less dissatisfaction among patients, in comparison to vaginal progesterone.