trelstar and Pelvic-Pain

The recurrence of deep infiltrating endometriosis (DIE) after its surgical excision is a big problem: postoperative treatment is crucial.. To compare two postoperative treatments: Dienogest and GnRH agonists.. Prospective Randomized Controlled Trial (RCT).. 146 women submitted to laparoscopic eradication of DIE with bowel and parametrial surgery.. The primary outcome was to demonstrate the non-inferiority of Dienogest about the reduction in pain recurrence. Secondary outcomes were differences in terms of treatment tolerability, side effects, imaging relapse rate, and pregnancy rate.. Both Dienogest and GnRH agonists were associated with a highly significant reduction of pain at 6 and 30 months, without any significant difference (. Dienogest has proven to be as effective as GnRH agonists in preventing recurrence of DIE and associated pelvic pain after surgery. Also, it is better tolerated by patients.

Topics: Endometriosis; Female; Gonadotropin-Releasing Hormone; Humans; Intestines; Laparoscopy; Leuprolide; Nandrolone; Pelvic Pain; Peritoneum; Postoperative Care; Pregnancy; Recurrence; Reoperation; Secondary Prevention; Treatment Outcome; Triptorelin Pamoate

Chronic cyclic pelvic pain (CCPP) affects women's quality of life and pituitary downregulation is often used for symptomatic relief. However, prolonged suppression of ovarian function is associated with menopausal side effects and can lead to osteoporosis. Currently, the use of gonadotropin releasing hormone agonists (GnRHa) for treatment of CCPP is usually restricted to 6-9 months, limiting their efficacy. There is limited information regarding safety and efficacy with longer-term use. The aim of this study is to examine the safety and efficacy of long-term (24 months) pituitary down-regulation with the GnRHa (Triptorelin SR) with add-back therapy (ABT) using Tibolone for symptom relief in women with CCPP.. A single-arm, prospective clinical trial at a Tertiary University Teaching Hospital of 27 patients receiving Triptorelin SR (11.25 mg) and Tibolone (2.5 mg). Outcomes measures were the safety of treatment assessed by clinical examination, haematological markers, liver and renal function tests and bone mineral density (BMD) at 12, 18 and 24 months as well as at 6 months post-treatment. Pain and health-related quality of life (HR-QoL) assessed using the endometriosis health profile (EHP-30) and chronic pain grade (CPG) questionnaires.. There was no evidence for any significant harmful effects on any of the measured haematological, renal or liver function tests. Although results regarding the effect on BMD are not conclusive there is an increased risk of development of osteopaenia after 12 months of treatment. Pain and HRQoL assessments showed significant improvement during medication, but with deterioration after treatment cessation.. Long- term Triptorelin plus Tibolone add-back therapy in women suffering from CCPP does not appear to be associated with significant serious adverse events apart from the possibility of deterioration in the BMD that needs to be monitored. This mode of therapy appears to be effective in pain relief and in improving quality of life over a 24-month period.. Clinical trials database NCT00735852.

Topics: Adult; Bone Density; Chronic Pain; Drug Therapy, Combination; Female; Follow-Up Studies; Humans; Norpregnenes; Pain Measurement; Pelvic Pain; Prospective Studies; Quality of Life; Time Factors; Treatment Outcome; Triptorelin Pamoate

To evaluate the effectiveness of triptorelin for the treatment of adenomyosis, the benign invasion of endometrial tissue into the myometrium, as a fertility-preserving alternative to the gold standard hysterectomy.. In this multicenter, open-label, observational study in Russia, performed from November 3, 2011, to August 24, 2015, we assessed the efficacy and safety of triptorelin 3.75 mg administered intramuscularly every 28 days in Russian women who were gonadotropin-releasing hormone agonist treatment-naïve, aged 25-40 years, and had a diagnosis of endometriosis or adenomyosis with heavy menstrual bleeding. We performed a medical record review, interviews to assess symptom severity, and pelvic assessments including transvaginal ultrasound. Data were obtained at first injection of triptorelin (visit 1), on the day of last injection (visit 2), 6 months after last injection (visit 3), and 9 months after last injection (visit 4). Significance was assessed by Wilcoxon signed rank test.. A total of 465 women were included. There was a significant improvement from baseline in severity of heavy menstrual bleeding in 390/463 (84.2%) of women 6 months after last injection (P<0.0001). Severity of dysmenorrhea, abnormal uterine bleeding, and pelvic pain was decreased at visit 3 compared with baseline (P<0.0001). Endometriosis symptoms stopped in 253/262 (96.6%) of women at visit 2 and in 243/263 (92.4%) of women at visit 3. Pregnancy was reported in 116/465 (24.9%) women within 9 months following the end of treatment.. Triptorelin has a favorable safety profile, is highly efficacious in treating clinical symptoms of adenomyosis, and improves reproductive function. ClinicalTrials.gov registration number: A-38-52014-191, registered October 2011.

Topics: Adenomyosis; Adult; Dysmenorrhea; Endometriosis; Female; Humans; Menorrhagia; Pelvic Pain; Reproductive Health; Russia; Triptorelin Pamoate; Uterine Diseases

When aromatase inhibitors are used to treat premenopausal women with endometriosis, additional drugs should be used to effectively down-regulate gonadal estrogen biosynthesis. This randomized prospective open-label study compared the efficacy in treating pain symptoms and the tolerability of letrozole combined with either norethisterone acetate or triptorelin.. Women with pain symptoms caused by rectovaginal endometriosis were treated with letrozole (2.5 mg/day) and were randomized to also receive either oral norethisterone acetate (2.5 mg/day; group N) or intramuscular injection of triptorelin (11.25 mg every 3 months; group T). The scheduled length of treatment was 6 months. A visual analogue scale and a multidimensional categorical rating scale were used to assess the severity of pain symptoms. The volume of the endometriotic nodules was estimated by ultrasonography using virtual organ computer-aided analysis. Adverse effects of treatment were recorded.. A total of 35 women were randomized between the two treatment protocols. Significantly more patients in group N rated their treatment as satisfactory or very satisfactory (64.7%) as compared to group T (22.2%; p=0.028). The intensity of both non-menstrual pelvic pain and deep dyspareunia significantly decreased during treatment in both study groups, though no statistically meaningful difference between the two groups was apparent. Reduction in the volume of endometriotic nodules was significantly greater in group T than in group N. Interruption of treatment due to adverse effects significantly differed between the groups, with 8 women in group T (44.4%) and 1 woman in group N (5.9%) interrupting treatment (p=0.018). Similarly, 14 women included in group T (77.8%) and 6 women included in group N (35.3%) experienced adverse effects of treatment (p=0.018). During treatment, mineral bone density significantly decreased in group T but not in group N.. Aromatase inhibitors reduce the intensity of endometriosis-related pain symptoms. Combining letrozole with oral norethisterone acetate was associated with a lower incidence of adverse effects and a lower discontinuation rate than combining letrozole with triptorelin.

Topics: Adult; Aromatase Inhibitors; Drug Therapy, Combination; Dyspareunia; Endometriosis; Female; Humans; Letrozole; Nitriles; Norethindrone; Norethindrone Acetate; Patient Satisfaction; Pelvic Pain; Triazoles; Triptorelin Pamoate; Ultrasonography

To investigate the role of adjuvant treatment with gonadotropin-releasing-hormone agonist (GnRHa) following conservative surgical treatment of endometriosis.. Sixty patients in the reproductive age (mean age 28.6 years), with symptomatic stages III and IV endometriosis following laparoscopic surgery and without previous hormonal treatment were enrolled in a prospective, randomized, controlled trial to compare the effects of 3-month treatment with triptorelin depot-3.75 i.m. (30 patients) versus expectant management using placebo injection (30 patients).. Six patients (one in triptorelin group and five in placebo group) were lost at follow-up, the remaining 54 were suitable for analysis. Pelvic pain persistence or recurrence, endometrioma relapses and pregnancy rate were evaluated during a 5-year follow-up. The results of 29 cases treated with triptorelin and 25 that received placebo did not show significant differences in pain recurrence (P=1, RR=0.94, 95% CI=0.57-1.55), endometrioma relapse (P=0.67, RR=1.29, 95% CI=0.66-2.50), and pregnancy rate in infertile women (P=0.80, RR=0.81, 95% CI=0.37-1.80). Curves of time of pain recurrence and pregnancy during 5-year follow-up did not show significant differences between the two groups (P=0.79 and P=0.51, respectively, using Mantel-Haenzsel logrank test).. Triptorelin treatment after operative laparoscopy for stage III/IV endometriosis does not appear to be superior to expectant management in terms of prevention of symptoms recurrence and endometrioma relapse, and has no influence on pregnancy rate in endometriosis-associated infertility.

Topics: Adult; Chemotherapy, Adjuvant; Endometriosis; Female; Fertility; Humans; Laparoscopy; Luteolytic Agents; Pelvic Pain; Pregnancy; Pregnancy Rate; Secondary Prevention; Triptorelin Pamoate

The most effective therapy for endometriosis is a matter for debate. The aim of the present randomized study was to evaluate the efficacy of low doses of danazol on recurrence of pelvic pain in patients with moderate or severe endometriosis, who had undergone laparoscopic surgery and 6 months of gonadotrophin-releasing hormone analogue (GnRHa) therapy. After surgery, 28 patients with moderate or severe endometriosis underwent therapy for 6 months with GnRHa i. m. every 4 weeks. They were then randomized into two groups: group A (14 subjects) was treated with 100 mg/day danazol for 6 months; group B (14 subjects, control) did not receive any type of therapy. After 12 months of treatment, group A had a significantly (P < 0.01) lower pain score than group B. There was no significant difference between the groups in oestrogen concentrations, bone mineral density or side-effects. The results suggest that low-dose danazol therapy reduces recurrence of pelvic pain in patients with moderate or severe endometriosis, treated surgically, and has few or no metabolic side-effects.

Topics: Danazol; Endometriosis; Estradiol; Estrogen Antagonists; Female; Humans; Laparoscopy; Pelvic Pain; Recurrence; Triptorelin Pamoate

To compare the effect of a GnRH-agonist, triptorelin, versus placebo on the symptoms of endometriosis.. A prospective, randomized, double-blind study of 6 months of treatment followed by 12 months of follow-up.. Departments of Obstetrics and Gynecology at two universities and one general hospital.. Forty-nine women with symptoms of laparoscopically verified endometriosis.. Triptorelin depot or placebo was given every 4 weeks. Clinical evaluation, including the Duration Intensity Behavior Scale and Visual Analogue Scale for pain, was performed before the injections and up to 12 months after treatment. A control laparoscopy was performed 4-6 weeks after the last injection.. Quantitation of pain.. Twenty-four patients had active treatment and 25 received placebo. Pain symptoms according to both scales were significantly more reduced after 2 months of triptorelin treatment compared to placebo. The extent of endometriotic lesions was reduced 50% during triptorelin treatment and increased 17% during placebo. The average area of endometriotic lesions was reduced 45% during triptorelin treatment but was unchanged during placebo. Side effects, mainly hot flushes, were experienced by 80% of the actively treated group but also by 33% of patients in the placebo group. Because of recurrent symptoms, only five patients could be observed for 12 months after completion of treatment.. Triptorelin reduces endometriotic lesions and pain to a significantly higher degree than placebo.

Topics: Adult; Delayed-Action Preparations; Double-Blind Method; Endometriosis; Female; Follow-Up Studies; Humans; Luteolytic Agents; Pain Measurement; Patient Dropouts; Pelvic Pain; Prospective Studies; Time Factors; Triptorelin Pamoate

To compare treatment efficacy and safety parameters a total of 55 premenopausal women with histologically proven endometriosis (stage II-IV) were randomized to receive the LHRH-analogue depot triptorelin (n = 30) or the steroid danazol (n = 25) for a total of 24 weeks. Immediately after cessation of the endocrine therapy a second-look operation was performed. Four as well as 24 weeks after the end of treatment patients were seen for re-evaluation of clinical symptoms and safety parameters. Estradiol suppression was significantly more pronounced with triptorelin, while the free androgenic index rose with danazol. Both substances were equally effective in reducing endometriotic implants (58% and 51%, respectively). Dysmenorrhea was absent at the end of medical therapy in both treatment groups. Dyspareunia and pelvic pain decreased at least by 50%. Red blood count, thrombocytes, liver enzymes and the atherogenic index rose with danazol, while the urinary calcium/creatinine ratio showed a marked elevation with triptorelin. Adverse effects were mainly due to the hypoestrogenism of the LHRH analogue and the androgenic/anabolic properties of the steroid. Triptorelin and danazol are equally effective in treating endometriosis. Therefore, choice of treatment should be based on the patient's medical history and the pharmacological profile of each substance.

Topics: Adult; Danazol; Dehydroepiandrosterone; Dehydroepiandrosterone Sulfate; Delayed-Action Preparations; Dysmenorrhea; Dyspareunia; Endometriosis; Estradiol; Female; Follicle Stimulating Hormone; Humans; Luteal Phase; Luteinizing Hormone; Pelvic Pain; Progesterone; Triptorelin Pamoate; Uterine Hemorrhage

Triptorelin is one of the most commonly used gonadotropin-releasing hormone agonists and has been used in the treatment of deep infiltrating endometriosis (DIE). This study aimed to evaluate the efficacy and safety of up to 24 weeks of triptorelin treatment after conservative surgery for DIE.This prospective, non-interventional study was performed in 18 tertiary hospitals in China. Premenopausal women aged ≥18 years treated with triptorelin 3.75 mg once every 28 days for up to 24 weeks after conservative surgery for DIE were included. Endometriosis symptoms were assessed, using a visual analogue scale (0-10 cm) or numerical range (0-10), at baseline (pre-surgery) and routine visits 3, 6, 9, 12, 18, and 24 months after surgery. Changes in symptom intensity over time were primary outcome measures.A total of 384 women (mean [standard deviation] age, 33.4 [6.2] years) were analyzed. Scores for all symptoms (pelvic pain, dysmenorrhea, ovulation pain, dyspareunia, menorrhagia, metrorrhagia, and gastrointestinal and urinary symptoms) assessed decreased from baseline over 24 months. Cumulative improvement rates in pelvic pain, dysmenorrhoa, ovulation pain, and dyspareunia were 74.4%, 83.6%, 55.1%, and 66.9%, respectively. The 24-month cumulative recurrence rate (≥1 symptom) was 22.2%. The risk of symptom recurrence was higher in patients with ≥2 versus 1 lesion (odds ratio [OR] 2.539; 95% CI: 1.458-4.423; P = .001) and patients with moderate (OR 5.733; 95% CI: 1.623-20.248; P = .007) or severe (OR 8.259; 95% CI: 2.449-27.851; P = .001) pain versus none/mild pain. Triptorelin was well tolerated without serious adverse events.Triptorelin after conservative surgery for DIE improved symptoms over 24 months of follow up. The recurrence rate of symptoms was low and triptorelin was generally well tolerated.Trial registration number: ClinicalTrials.gov, NCT01942369.

Topics: Adult; China; Dyspareunia; Endometriosis; Female; Humans; Pelvic Pain; Prospective Studies; Triptorelin Pamoate

To compare the efficacy of the oral dienogest versus triptorelin acetate injection for treatment of premenopausal menorrhagia and pelvic pains in women with uterine adenomyosis.. A total of 41 patients with adenomyosis suffering from pelvic pains and menorrhagia were recruited. First group was managed with oral dienogest (2 mg/day, orally) while the second group received triptorelin acetate (3.75 mg/4 weeks, subcutaneous injection) for 16 weeks. Outpatient follow-up was undertaken after 8 weeks but mean values were calculated at baseline and after 16 weeks (end of treatment).. A total of 41 women were allocated to treatment with dienogest (n = 22) or triptorelin acetate (n = 19); 19 (86.4 %) and 18 (94.7 %) % of the respective groups completed the trial. Significant reductions in pelvic pains after 16 weeks treatment were obtained in both groups demonstrating the equivalence of dienogest relative to triptorelin acetate. Triptorelin acetate was more effective in controlling of menorrhagia and reduction of uterine volume.. Dienogest may be a valuable alternative to depot triptorelin acetate for treatment of premenopausal pelvic pains in women with uterine adenomyosis.

Topics: Adenomyosis; Administration, Oral; Adult; Endometriosis; Female; Humans; Injections, Subcutaneous; Menorrhagia; Middle Aged; Nandrolone; Pelvic Pain; Premenopause; Prospective Studies; Treatment Outcome; Triptorelin Pamoate