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Intensive care patients can experience significant long-term impairment in mobility and function caused by their critical illness. A potential contributory factor apart from critical illness polymyoneuropathy is the low levels of anabolic hormones in these patients. Testosterone levels in critically ill patients are extremely low, even in the latter recovery phase. A potential solution to critical illness myopathy may be to provide anabolic support in addition to standard care (early physiotherapy) to further improve gains in strength. This project aims to test whether a synthetic testosterone (nandrolone) improves muscle strength in ICU survivors compared to placebo. GAINS 2.0 is a multicentre, randomised, double blinded placebo-controlled trial which will allocate ICU patients in a 1:1 ratio to nandrolone compared to placebo which commenced recruitment in July 2023. Adult patients admitted to the ICU, receiving nutrition for a minimum of 24 hours with an ICU stay of at least 5 days, or patients with significant weakness as result of their ICU stay (such that they are unable to mobilise independently) will be eligible to participate. Sample size will be 54 patients. Patients will be randomised to receive nandrolone 100mg (males) / 50mg(females) weekly for 3 weeks in addition to standard care. The co-primary outcomes are the time to walking with one person assisting (Intensive Care Mobility scale = 8 or more, in days from randomisation), change in muscle strength measured by the Medical Research Council (MRC) muscle strength sum score from enrolment to hospital discharge and number of days out of hospital up to day 90 post-discharge. Secondary outcomes are grip strength measured by hand-held dynamometry. SF-36 scores (quality of life and functional domains), and days to return to work, for those working pre-ICU, will be collected via a 3-month phone follow-up. A previous pilot feasibility trial showed that nandrolone is safe and feasible. We hypothesize nandrolone will improve muscle strength and physical functioning at hospital discharge and at follow-up. The results of this trial may have significant interest to clinicians and patients considering the large and increasing number of patients surviving intensive care but with physical impairment. This trial may have significant implications on lowering hospital costs and daily adjusted life years. anzctr.org.au; No.: ACTRN12623000729628 URL: anzctr.org.au.

Background Ovarian endometrioma is a common gynecological disease that is often treated with surgery or hormonal treatment. Ovarian cystectomy, a surgical procedure for ovarian endometrioma, can result in impaired ovarian reserve. Methods We conducted a randomized controlled trial to evaluate the efficacy of hormonal treatment [gonadotropin-releasing hormone agonist (GnRHa) or dienogest (DNG)] for preserving ovarian reserve after cystectomy for ovarian endometrioma. The primary endpoint was the level of serum Anti-Müllerian hormone (AMH) as a marker of ovarian reserve. Results Before and after laparoscopic surgery, 22 patients in the GnRHa group and 27 patients in the DNG group were administered hormonal treatment for a total of 4 months. After 1-year follow-up, >60% of the patients in the DNG group retained over 70% of their pretreatment AMH levels, whereas no patient in the GnRHa group retained their AMH levels after cystectomy ( P < 0.01). Interleukin-6 (IL-6) is a key cytokine involved in inflammation. Compared with the GnRHa group, patients in the DNG group had lower IL-6 levels at the end of treatment. Conclusions Our data revealed that DNG is more effective than GnRHa in preserving ovarian reserve after cystectomy of ovarian endometrioma. This is achieved through the reduction of the inflammatory response during the perioperative period and other endometriosis-related inflammatory reactions. Trial registration The registration number of this trial is UMIN-CTR, UMIN000018569, registered 6 August 2015, https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021492 , and Japan Registry of Clinical Trials, jRCTs041180140, registered 29 March 2019, https://jrct.niph.go.jp/en-latest-detail/jRCTs041180140 . This randomized controlled trial was conducted in accordance with the CONSORT guidelines.

Objective To explore the clinical efficacy of commonly used conservative treatments for adenomyosis using both TCM and Western medicine. Methods 210 patients with adenomyosis were selected and divided into 3 groups: Group A (Dan’e Fukang), Group B (Dienogest), and Group C (Goserelin + Mirena), with 70 cases in each group. Afterward, indicators were collected for comparison. Results Different treatment approaches exhibited varying effects on uterine VAS, and PBAC among the 3 groups ( P  < 0.001). The effects of different treatment approaches on serum levels of estradiol (E2), FSH, and CA125 also differed among the 3 groups ( P  < 0.001). After 3 months of treatment, the incidence of adverse reactions among the 3 groups was significantly different ( P  < 0.001), with further comparison indicating a lower incidence of adverse reactions in Groups A and B than in Group C ( P  < 0.017). Meanwhile, statistically significant differences in the incidence of adverse reactions among the 3 groups were observed again after 6 months of treatment ( P  = 0.004), with further comparison revealing a lower incidence of adverse reactions in Group B than in Group C. Additionally, the comparison of uterine volume ( P  < 0.001) and VAS ( P  < 0.001) among the 3 groups was different after 12 months of treatment, and further comparison revealed that the uterine volume was ranked as Group B > Group C > Group A, while the pelvic pain VAS scores were ranked as Group C > Group B = Group A. Conclusion Dan’e Fukang Decoction is markedly effective in alleviating pain; Goserelin + Mirena exhibits significant efficacy in reducing bleeding.

Background To evaluate the effects of a combined oral contraceptive containing 1.5 mg 17b-estradiol (E2) and 2.5 mg nomegestrol acetate (NOMAC) or 2 mg/daily dienogest (DNG) oral progestin on endometriosis-associated chronic pelvic pain (CPP) and on the quality of life (QoL) and sexual function, by a randomized study design. Methods The E2/NOMAC group and DNG group included 99 and 98 women, respectively. The levels of CPP were measured by the visual analogic scale (VAS). The QoL scores were investigated by the Short Form-36 questionnaire (SF-36). Finally, sexual function was studied using the Female Sexual Function Index (FSFI), while sexual distress was studied by the Female Sexual Distress Scale (FSDS). The study had 3, 6 and 12-month follow-ups. Results The intra-group analysis showed an improvement of the VAS score from baseline to the 12-month follow-up in the women of both groups ( p  < 0.001). The inter-group comparison showed a similar improvement of CPP ( p  = 0.06). Women on DNG had better SF-36 somatic ( p  < 0.01) and FSFI scores ( p  < 0.006) than women on E2/NOMAC at the 6- and 12-month follow-ups. Conclusions The results support the efficacy of both hormonal treatments, even if DNG was more effective than E2/NOMAC in a limited intergroup comparison.

The treatment of endometriosis includes analgesics, hormone therapy, and surgery. Even after surgical removal of endometriotic lesions, the risk of recurrence remains high once the normal menstrual cycle resumes. Therefore, long-term hormone therapy is essential to prevent recurrence. Among hormonal treatments, low-dose estrogen progestin preparations are not recommended for patients older than 40 years due to the increased risk of thrombotic side effects. In contrast, dienogest does not carry a thrombotic risk, making it a suitable option for older patients. Although dienogest requires long-term administration until menopause in patients with endometriosis, data on its long-term efficacy and potential adverse effects remain limited. In particular, comparative studies assessing the safety and effectiveness of long-term use of dienogest at different doses (1 mg/day vs 2 mg/day) have not been conducted, highlighting the need for further investigation. The purpose of this study is to investigate the efficacy and the incidence of adverse events of dienogest 1 mg/day after 48 weeks in patients with dysmenorrhea due to endometriosis, compared with dienogest 2 mg/day. This randomized, open-label, parallel-group, dose-comparison, multicenter trial follows the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 guidelines and is conducted at 6 centers in Japan. Participants are randomly assigned in a 1:1 ratio to receive either dienogest 1 mg/day or 2 mg/day. The drug is administered for 48 weeks, and its therapeutic effects and side effects are evaluated. Hospital visits include the use of questionnaires, vital sign measurements, imaging studies (magnetic resonance imaging and ultrasound), blood tests, and bone density assessments. The primary endpoint is the change in the pain visual analog scale (VAS) score from baseline to 48 weeks. The VAS is a 10 cm horizontal scale where 0 cm represents no pain and 10 cm represents the maximum imaginable pain; participants indicate their pain level on the scale, and the change is analyzed over time. The target sample size is 88, determined with a noninferiority margin based on existing literature. The protocol was approved by the Nagoya City University Hospital Clinical Research Review Board. Findings will be presented at academic conferences and published in peer-reviewed journals. Currently, data collection is ongoing. The first participant was enrolled in August 2021. As of March 22, 2025, a total of 88 participants had been enrolled in this clinical trial. This is the first trial to compare efficacy and safety between 1 mg/day and 2 mg/day of long-term dienogest use in patients with dysmenorrhea caused by endometriosis. Combining diagnostic imaging with patient questionnaires and blood tests allows the determination of efficacy against endometriosis itself. Japan Registry of Clinical Trials jRCTs041210016; https://jrct.mhlw.go.jp/en-latest-detail/jRCTs041210016. DERR1-10.2196/66246.

PurposeTo compare the effects of preoperative dienogest (DNG) and gonadotropin-releasing hormone (GnRH) agonist administration on the improvement of preoperative symptoms and surgical outcomes in patients who underwent laparoscopic cystectomy for ovarian endometriomas.MethodsSeventy patients who were scheduled for laparoscopic surgery were enrolled in the study. They were divided into two groups: 35 patients who received DNG for 4 months preoperatively (group D) and 35 patients who received low-dose sustained-release goserelin acetate for 4 months preoperatively (group G). Preoperative outcomes, including pain score associated with endometriosis, using the numerical rating scale (NRS), adverse events of hormonal therapy and Kupperman index (KI) before and after treatment, surgical outcomes including total surgical duration and blood loss, and postoperative recurrence of endometrioma were compared between the two groups.ResultsRegarding preoperative symptoms, NRS and KI at 4 months after preoperative hormonal therapy were significantly lower in group D than in group G (NRS, 5.3 ± 5.5 vs. 2.7 ± 3.9; P = 0.01; KI, 16.0 ± 11.0 vs. 9.2 ± 7.6; P = 0.006). Regarding adverse events, the incidence of hot flashes was significantly lower in group D than in group G (P < 0.001). Meanwhile, the incidence of breast pain and metrorrhagia was significantly higher in group D than in group G (P = 0.04 and P < 0.001, respectively). The total surgical duration and blood loss were not significantly different between the groups. At 12 months after surgery, ovarian endometrioma did not recur in either group.ConclusionPreoperative administration of DNG is more valuable for patients with endometriosis and scheduled for laparoscopic surgery to improve symptoms with good efficacy and tolerability than the administration of GnRH agonist.

Background Endometriosis is considered to be the most intractable cause of female infertility. Administering any type of treatment for endometriosis before in vitro fertilization and embryo transfer (IVF-ET) is an important strategy for improving the IVF-ET outcomes for infertile women with endometriosis. In fact, treatment with a gonadotropin-releasing hormone (GnRH) agonist just before IVF-ET has been reported to improve the clinical outcome in endometriosis patients. However, the benefit of Dienogest (DNG), a synthetic progestin, treatment just before IVF-ET remains unclear. Methods Sixty-eight infertile women with Stage III or IV endometriosis (ovarian endometrial cyst < 4 cm) were recruited for this study. The subjects were divided into 2 groups: a DNG group ( n  = 33) and a control group ( n  = 35). DNG was administered orally every day for 12 weeks prior to the conventional IVF-ET cycle in the DNG group. Standard controlled ovarian hyperstimulation with the GnRH agonist long protocol was performed in the control group. The numbers of mature follicles and retrieved oocytes, fertilization rates, implantation rates, and clinical pregnancy rate were compared between the two groups. In addition, the concentrations of inflammatory cytokines, oxidative stress markers, and antioxidants in follicular fluids were also measured. Results The numbers of growing follicles, retrieved oocytes, fertilized oocytes, and blastocysts were significantly lower in the DNG group than in the control group. The fertilization and blastocyst rates were also lower in the DNG group than in the control group. Although there was no significant difference in the implantation rate between the groups, the cumulative pregnancy rate and live birth rate were lower in the DNG group than in the control group. There was no significant difference in the abortion rate. Our results failed to show that DNG reduces the inflammatory cytokine levels and oxidative stress in follicular fluids. Conclusions Administering DNG treatment just before IVF-ET did not provide any benefits to improve the clinical outcomes for infertile women with endometriosis.

Objective To compare the efficacy of dienogest and GnRH-a after endometriosis surgery. Methods Patients with endometriosis who were admitted to our hospital from December 2020 to March 2022 were randomly collected. A total of 81 patients were collected and divided into 40 cases in the control group and 41 cases in the observation group. Among them, the control group was treated with GnRH-a drug, and the observation group was treated with dienogest (DNG). Results The study found that the therapeutic effects of the two drugs were basically the same in patients with endometriosis. The VAS and Kupperman scores of the control group were 0.78 ± 0.8, 3.9 ± 1.84, P  < 0.05, respectively; the VAS and Kupperman scores of the observation group were 0.73 ± 0.78, 1.55, respectively ± 1.24, P  < 0.05, the difference was statistically significant.In the case of postoperative recurrence, the observation group was better than the control group, with 8 cases of recurrence in the control group and 2 cases of recurrence in the observation group,  P  < 0.05. Conclusion In the comparison of postoperative efficacy of the two drugs on patients with endometriosis, dienogest is better than GnRH-a adjuvant drug in postoperative recurrence, and has a good improvement and application, which is worthy of further promotion in clinical practice.

ObjectivesTo compare the effectiveness of dienogest (DIE) and norethisterone acetate (NETA) regimens in the treatment of endometrial hyperplasia (EH) without atypia.MethodsParticipants were premenopausal women with irregular uterine bleeding, and endometrial hyperplasia without atypia on endometrial biopsy. Enrolled patients were randomly allocated into two groups: group I got DIE 2 mg/day (orally Visanne) for 14 days (10th to the 25th day of cycle) while group II received between the 16th and 25th day of the cycle, norethisterone acetate (NETA) 15 mg/d (orally Primolut Nor) was administered for 10 days. Both groups continued the therapy for six months.ResultsThe DIE group showed a higher resolution (32.7%) and regression (57.7%) than NETA group (31% & 37.9%, respectively) with significant regression (p = 0.039). No progression in DIE group while four (6.9%) women in NETA group were recorded a progression to complex type without a significance. Also, NETA group showed a significant persistence rate (22.5%) than DIE group (3.8%) (p = 0.005). Also number in NETA group managed by hysterectomy with significant difference (p = 0.042).ConclusionIf used as first-line treatment, Dienogest produces a better rate of regression and a lower incidence of hysterectomy than Norethisterone Acetate does when used in EH without atypia.

Objective The primary aim of the study was to analyze the endometrioma recurrence rate in patients who underwent laparoscopic excision followed by postoperative long-term regimen of oral contraceptives (OCs). Materials and methods 168 patients who underwent a conservative laparoscopic surgery for endometrioma, during the period between September 2009 and August 2010 in three university hospitals were studied. A long-term OCs therapy was offered to all women following surgery. Patients were randomly divided into three groups according to different progestins used (desogestrel, gestodene, dienogest). Women who refused a postoperative hormonal therapy served as control. Follow-up visits and transvaginal scan were planned at 1, 3, 6, 12, and 24 months after surgery. All patients who showed an ultrasound persistence of the endometrioma at 1 month follow-up were excluded from clinical analysis. Results Of the 168 patients, 131 completed the 24 months follow-up. Endometrioma recurrence was found in 21 (12.5 %) of all patients, it was unilateral in 17 cases while bilateral in 4 cases. The rate of recurrent endometrioma was statistically significant in non-users compared to the long-term OCs treated patients. Conclusion The current data suggest the usefulness of long-term OCs regimen after conservative surgery for the prevention of ovarian endometrioma recurrence. As a statistical significant difference could not be observed between OCs groups, further study on the individual molecules is required in order to really understand the effect of each of them.