leuprolide and Pain

We aimed to examine how leuprorelin has been studied for the treatment of women with endometriosis in Asia. We conducted a literature search of PubMed, the Cochrane Library and ClinicalTrials.gov. This review includes randomised trials of women with endometriosis treated with leuprorelin in Asia. Phase I-IV clinical trials published between January 1 2000 and December 31 2016 and written in English were included. Four studies were identified, showing that leuprorelin significantly improves pain and quality of life. The oestrone and oestradiol levels are decreased by leuprorelin but can be increased using an 'add-back' therapy with conjugated equine oestrogen and methoxyprogesterone. Menopause is more common in women treated with leuprorelin. The bone mineral density is reduced in women treated with leuprorelin. There are limited studies investigating the use of leuprorelin for the treatment of endometriosis in Asian populations. However, the research that has been conducted supports the use of leuprorelin in an Asian population.

Topics: Asian People; Endometriosis; Female; Gonadotropins; Humans; Leuprolide; Pain

Androgen deprivation therapy is a mainstay for the treatment of advanced prostate cancer. Hormonal therapy commonly consists of injection of gonadotropin hormone-releasing hormone agonists. Based on the need for improved convenience of administration, a novel formulation of leuprolide acetate (Eligard; Atrix Laboratories Inc. & Sanofi Aventis) which incorporates a mixture of selected polymers and solvents to achieve sustained drug delivery after subcutaneous injection, was developed. The US Food and Drug Administration has approved 1-, 3-, 4- and 6-month formulations of leuprolide acetate. In clinical trials, leuprolide acetate achieves sustained suppression of serum testosterone to castration levels (< or =50 ng/dl). The adverse-event profile is consistent with the effects of testosterone suppression. This novel delivery system in addition to the availability of a 6-month formulation of leuprolide acetate, offers patients the option of a convenient twice-yearly injection schedule.

Topics: Antineoplastic Agents, Hormonal; Clinical Trials as Topic; Delayed-Action Preparations; Drug Administration Schedule; Humans; Injections, Subcutaneous; Leuprolide; Male; Pain; Prostatic Neoplasms

Endometriosis is a common condition for which a number of treatments have been proposed. Medical treatments are based on the hormonal responsiveness of endometriosis implants. These therapies include progestins (with or without estrogens), androgens, and gonadotropin-releasing hormone (GnRH) analogs. Surgical treatments may include hysterectomy with oophorectomy or organ-sparing surgery involving ablation or resection of visible lesions of endometriosis and restoration of pelvic anatomy. There are no studies that directly compare the effectiveness or adverse effects of medical therapy and surgical therapy. Studies on medical therapy compare different treatments with placebo or with other active treatments. Hormone-based therapies for endometriosis show 80%-100% effectiveness in relief of pelvic pain over a 6-month course of therapy. Serious adverse outcomes after medical therapy are unusual. Studies on surgical therapy are largely anecdotal, with noncomparative reports on a variety of surgical methods. A few comparative surgical studies have been reported. Because of the noncomparative nature of many of the surgical studies, the use of combinations of surgical procedures and techniques in the reported studies, and the reporting of results from surgeons with an unusually high level of technical skill, the gynecological practitioner has little basis in the literature for assessing the optimum surgical approach. Surgical complications are believed to be underreported and may be related to how aggressive a surgical procedure is undertaken.

Topics: Androgens; Contraceptives, Oral; Danazol; Endometriosis; Estrogen Antagonists; Female; Gonadotropin-Releasing Hormone; Hormones; Humans; Hysterectomy; Laparoscopy; Leuprolide; Nafarelin; Ovariectomy; Pain; Pain Measurement; Progestins; Recurrence; Research Design; Treatment Outcome

Most cases of advanced carcinoma of the prostate are hormonosensitive. The use of combined androgen blockade (CAB) seems to improve survival and quality of life, but only when combined with chemical castration by luteinizing-hormone-releasing hormone analog and without the use of steroidal antiandrogens. After CAB, further hormonal treatments remain efficacious, such as antiandrogen withdrawal followed by estrogens, aromatase inhibitors, and hormone-refractory prostate cancer multiple cytotoxic agents. For painful bone lesions, external beam radiotherapy, biphosphonates, and strontium 89 or samarium 153 provide pain relief. The use of new methods for the evaluation of response and quality of life will allow the rapid identification of effective treatments and permit powered phase III trials.

Topics: Androgen Antagonists; Bone Neoplasms; Brachytherapy; Combined Modality Therapy; Estrogens; Humans; Leuprolide; Male; Pain; Patient Care Planning; Prostatic Neoplasms; Quality of Life; Radiotherapy; Strontium Radioisotopes

To assess the cost-effectiveness of elagolix versus leuprolide acetate in women with moderate to severe endometriosis pain.. A Markov model was developed. The efficacy of leuprolide acetate was derived from statistical prediction models using elagolix trial data. Model inputs were extracted from Phase III clinical trials and published literature.. Compared with leuprolide acetate, elagolix generated positive net monetary benefit (NMB) assuming a payer's willingness-to-pay threshold of US$100,000 per quality-adjusted life year over a 1-year time horizon: US$5660 for elagolix 150 mg and US$6443 for elagolix 200 mg. The 2-year NMBs were also positive.. Elagolix was cost effective versus leuprolide acetate in the management of moderate to severe endometriosis pain over 1- and 2-year time horizons. Results were robust in sensitivity analyses.

Topics: Adolescent; Adult; Cost-Benefit Analysis; Endometriosis; Female; Fertility Agents, Female; Humans; Hydrocarbons, Fluorinated; Leuprolide; Markov Chains; Middle Aged; Models, Economic; Pain; Pyrimidines; Severity of Illness Index; United States; Young Adult

Use of gonadotropin-releasing hormone agonists (GnRHa) to treat endometriosis can cause mood and vasomotor side effects. "Add-back therapy," the combination of low-dose hormones, limits side effects but research is limited to adults. We sought to characterize quality of life (QOL) before treatment and to compare an add-back regimen of norethindrone acetate (NA) with conjugated estrogens (CEE) to NA alone for preventing side effects of GnRHa therapy in female adolescents with endometriosis.. Twelve-month double-blind, placebo-controlled trial.. Pediatric Gynecology clinic in Boston, Massachusetts.. Fifty female adolescents (aged 15-22 years) with surgically confirmed endometriosis initiating treatment with GnRHa.. Subjects were randomized to: NA (5 mg/d) with CEE (0.625 mg/d) or NA (5 mg/d) with placebo. All subjects received leuprolide acetate depot every 3 months.. The Short Form-36 v2 Health Survey, Beck Depression Inventory II, and Menopause Rating Scale were completed at repeated intervals.. At baseline, subjects reported impaired physical health-related QOL compared with national norms (all P < .0001). Over 12 months, these Short Form-36 v2 scores improved (all P < .05). Subjects receiving NA with CEE showed greater improvements in the pain, vitality, and physical health subscales (P. Female adolescents with endometriosis initiating GnRHa therapy have impaired QOL. Treatment with GnRHa combined with add-back therapy led to improved QOL, with no worsening of mood or menopausal side effects. NA with CEE was superior to NA alone for improving physical health-related QOL.

Topics: Adolescent; Boston; Contraceptives, Oral, Synthetic; Double-Blind Method; Drug Therapy, Combination; Endometriosis; Estrogens; Estrogens, Conjugated (USP); Female; Gonadotropin-Releasing Hormone; Humans; Leuprolide; Norethindrone; Norethindrone Acetate; Pain; Quality of Life; Treatment Outcome; Young Adult

Post-treatment prostate biopsy side-effects were evaluated in patients with locally advanced prostate cancer on endocrine therapy alone or combined with radiotherapy in the Scandinavian Prostate Cancer Group-7 randomized trial.. One-hundred and twenty patients underwent transrectalultrasound-guided biopsy, and were requested to complete a questionnaire on side-effects occurring within 7 days' follow-up.. The questionnaire was returned by 109 patients (91%) (endocrine therapy only 52%, combined endocrine therapy and radiotherapy 48%). Previous therapy had no significant influence on pain, urinary flow, haematuria or haematospermia. Pain at biopsy was reported in 63% (mild, 57%; moderate, 5.6%; severe, one patient) and pain at follow-up in 31% (mild, 27%; moderate, four patients). Haematuria (mean duration 2.2 days) was reported in 41%, and reduced urinary flow in 20% (mild, 18%; severe: four patients; no patient had urinary retention). Haematospermia was scarce. No patient reported urinary tract infection. Rectal bleeding occurred in 18% in the endocrine and 35% in the combined therapy group (p = 0.047), with a mean duration of 1.6 and 2.2 days, respectively (p = 0.031). In logistic regression analysis, a trend towards increased rectal bleeding was found in patients on combined endocrine therapy and radiotherapy (odds ratio 2.4, p = 0.050).. Patient-reported post-treatment prostate biopsy side-effects were mild and self-limiting.

Topics: Aged; Aged, 80 and over; Androgen Antagonists; Antineoplastic Agents, Hormonal; Biopsy; Combined Modality Therapy; Drug Therapy; Drug Therapy, Combination; Flutamide; Follow-Up Studies; Hematuria; Hemospermia; Humans; Incidence; Leuprolide; Logistic Models; Male; Middle Aged; Pain; Prostatic Neoplasms; Radiotherapy; Retrospective Studies; Surveys and Questionnaires

The study was conducted to evaluate the cardiovascular risk markers associated with endometriosis and the influence of the levonorgestrel intrauterine system (LNG-IUS) compared with the GnRH analogue (GnRHa) leuprolide acetate on these risk markers after 6 months of treatment.. This was a randomized, prospective, open clinical study, with 44 patients with laparoscopically and histologically confirmed endometriosis. Patients were randomized into two groups: the LNG-IUS group, composed of 22 patients who underwent LNG-IUS insertion, and the GnRHa group, composed of 22 patients who received a monthly GnRHa injection for 6 months. Body mass index; systolic and diastolic arterial blood pressure; heart rate; and laboratory cardiovascular risk markers such as interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-alpha), C-reactive protein (CRP), homocysteine (HMC), lipid profile, total leukocytes and vascular cell adhesion molecule (VCAM) were measured before and 6 months after treatment.. After 6 months of treatment, a significant reduction in pain score occurred in both groups with no significant difference in improvement between the two medications evaluated. In the LNG-IUS group, from pretreatment to posttreatment period, there was a significant reduction in the levels (mean+/-SD) of VCAM (92.8+/-4.2 to 91.2+/-2.7 ng/mL, p=.04), CRP (0.38+/-0.30 to 0.28+/-0.21 mg/dL, p=.03), total cholesterol (247.0+/-85.0 to 180.0+/-31.0 mg/dL, p=.0002), triglycerides (118.0+/- 76.0 to 86.5+/-41.5 mg/dL, p=.003), low-density lipoprotein cholesterol (160.5+/-66.0 to 114.5+/-25.5 mg/dL, p=.0005) and high-density lipoprotein cholesterol (63.0+/-20.5 to 48.5+/-10.5 mg/dL, p=.002). The GnRHa group showed an increase in HMC levels (11.5+/-2.9 to 13.0+/-2.7 mumol/L, p=.04) and a reduction in IL-6 levels (4.3+/-3.9 to 2.3+/-0.8 pg/mL, p=.005), VCAM (94.0+/-3.8 to 92.0+/-1.6 ng/mL, p=.03) and total leukocytes (7330+/-2554 to 6350+/-1778, p=.01). In the GnRH group, the remaining variables, including lipid profile, did not show any statistical difference.. This study shows that some cardiovascular risk markers are influenced by both GnRHa and the LNG-IUS, but the latter had a greater positive impact on the lipid profile, which could lead to a favorable effect during long-term treatment.

Topics: Adult; Biomarkers; Cardiovascular System; Contraceptive Agents, Female; Endometriosis; Female; Homocysteine; Humans; Interleukin-6; Intrauterine Devices, Medicated; Leuprolide; Levonorgestrel; Pain; Pain Measurement; Prospective Studies; Treatment Outcome; Tumor Necrosis Factor-alpha

To compare the efficacy and safety of SC depot medroxyprogesterone acetate (DMPA-SC 104) with that of leuprolide acetate in treatment of endometriosis.. Phase 3, multicenter, randomized, evaluator-blinded, comparator-controlled trial.. Clinical trial sites in Canada and United States.. Two hundred seventy-four women with surgically diagnosed endometriosis.. Intramuscular injections of DMPA-SC (104 mg) or leuprolide acetate (11.25 mg), given every 3 months for 6 months, with 12 months of posttreatment follow-up.. Reduction in five endometriosis symptoms or signs (dysmenorrhea, dyspareunia, pelvic pain, pelvic tenderness, pelvic induration); change in bone mineral density (BMD), hypoestrogenic symptoms, bleeding, and weight.. The depot medroxyprogesterone acetate given SC was statistically equivalent to leuprolide in reducing four of five endometriosis symptoms or signs at the end of treatment (month 6) and in reducing all five symptoms after 12 months' follow-up (month 18). Patients in the DMPA-SC 104 group showed significantly less BMD loss than did leuprolide patients at month 6, with scores returning to baseline at 12 months' follow-up. No statistically significant differences in median weight changes were observed between groups. Compared with leuprolide, DMPA-SC 104 was associated with fewer hypoestrogenic symptoms but more irregular bleeding.. Efficacy of DMPA-SC 104 was equivalent to that of leuprolide for reducing endometriosis-associated pain, with less impact on BMD and fewer hypoestrogenic side effects but more bleeding.

Topics: Adult; Bone Density; Delayed-Action Preparations; Endometriosis; Estrogens; Female; Flushing; Humans; Injections, Subcutaneous; Leuprolide; Medroxyprogesterone Acetate; Pain; Palliative Care; Quality of Life; Single-Blind Method; Treatment Outcome; Uterine Hemorrhage

To determine whether needle size influences a patient's perception of pain, 50 patients requiring hormonal manipulation for prostate cancer were blindfolded and randomised to receive two goserelin ('Zoladex') or two leuprorelin ('Prostap') injections, using 16- or 23-gauge needles, respectively. Median visual analogue scale pain scores for the first injections of goserelin and leuprorelin were below the level of clinical significance and were not statistically different. Mean administration time for goserelin was significantly shorter than for leuprorelin. In conclusion, there was no statistically significant difference in pain experienced on injection of goserelin and leuprorelin when patients were unaware of needle size.

Topics: Aged; Aged, 80 and over; Antineoplastic Agents, Hormonal; Goserelin; Humans; Leuprolide; Male; Middle Aged; Needles; Pain; Pain Measurement; Patient Satisfaction; Prostatic Neoplasms; Single-Blind Method

Luteinising hormone releasing hormone (LHRH) analogues are routinely used in the treatment of patients with advanced prostate cancer. This randomised crossover trial was conducted to compare patient comfort and tolerability between two commonly used LHRH analogues: goserelin acetate and leuprorelin acetate. A total of 50 patients were randomised into two groups, each receiving 6-monthly injections of leuprorelin acetate (a liquid presentation) and goserelin acetate (a depot pellet) and crossing over between treatments. Patients completed a simple visual analogue score for the discomfort felt from the injections. An analysis of variance model was used, and the results found that patients do tolerate leuprorelin acetate (0.589) better than goserelin acetate (1.343) (P < 0.001, CI = 95%).

Topics: Aged; Aged, 80 and over; Antineoplastic Agents, Hormonal; Cross-Over Studies; Delayed-Action Preparations; Goserelin; Humans; Injections, Subcutaneous; Leuprolide; Male; Middle Aged; Pain; Prostatic Neoplasms

These data compare the efficacy and safety of highly purified human-derived follicle-stimulating hormone (Bravelle) and recombinant follitropin-beta (Follistim) in women undergoing in vitro fertilization.. This report describes the pooled data from two, nearly identical, randomized, controlled, parallel-group, multicenter studies conducted in a total of 19 academic and private IVF-ET centers in the United States. Infertile premenopausal women underwent pituitary down-regulation using leuprolide acetate followed by a maximum of 12 days of subcutaneous Bravelle (n = 120) or Follistim (n = 118), followed by administration of human chorionic gonadotropin, oocyte retrieval and embryo transfer. The primary efficacy measure was the mean number of oocytes retrieved; secondary efficacy measures included the total dose and duration of gonadotropin treatment; peak serum estradion levels; embryo transfer and implantation rates; chemical, clinical and continuing pregnancies; and live birth rates. All adverse events were recorded and injection site pain was recorded daily using a patient, self-assessment diary.. Similar efficacy responses were observed for all outcome parameters in the two treatment groups. Although patients receiving Bravelle consistently reported a greater number of chemical, clinical and continuing pregnancies, as well as an increased rate of live birth, the data did not attain statistical significance (P > 0.05). The overall incidence of adverse events was similar in both groups, but compared to Follistim, injections of Bravelle were reported by patients to be significantly less painful (P < 0.001).. Bravelle and Follistim had comparable efficacy in controlled ovarian hyperstimulation in women undergoing IVF-ET. There were no differences in the nature or number of adverse events between the treatment groups although Bravelle injections were reported to be significantly less painful.

Topics: Adolescent; Adult; Chorionic Gonadotropin; Embryo Transfer; Female; Fertilization in Vitro; Follicle Stimulating Hormone; Follicle Stimulating Hormone, Human; Humans; Infertility, Female; Leuprolide; Oocytes; Ovulation Induction; Pain; Pregnancy; Pregnancy Outcome; Treatment Outcome

Raloxifene hydrochloride is a synthetic non-steroidal drug used for the prevention and treatment of post-menopausal osteoporosis. Pre-clinical and clinical data have shown that raloxifene may have a beneficial effect on leiomyomas. The aim of this prospective single-blind, randomized, placebo-controlled clinical trial was to evaluate the effectiveness of the addition of raloxifene to GnRH analogues on uterine, leiomyoma, and non-leiomyoma sizes, and on the occurrence of leiomyoma-related symptoms.. After randomization using a computer-generated list, 100 pre-menopausal women with symptomatic uterine leiomyomas received either leuprolide acetate depot plus raloxifene 60 mg daily (group A) or leuprolide plus placebo tablet (group B) for six cycles of 28 days. At baseline and after treatment, uterine, leiomyoma and non-leiomyoma sizes, and leiomyoma-related symptoms were evaluated for each woman. Analysis was by intention-to-treat method.. After six cycles of treatment, a significant decrease in uterine, leiomyoma, and non-leiomyoma sizes was detected in both groups in comparison with baseline. At the same time, no significant difference in uterine and non-leiomyoma sizes was observed between the groups. Leiomyoma sizes were significantly (P < 0.05) lower in group A than in group B. No difference was observed in leiomyoma-related symptoms between groups throughout the study period.. In women treated with GnRH analogue, the raloxifene administration induces a higher reduction of leiomyoma sizes.

Topics: Delayed-Action Preparations; Female; Hot Flashes; Humans; Leiomyoma; Leuprolide; Menorrhagia; Pain; Patient Dropouts; Placebos; Premenopause; Prospective Studies; Raloxifene Hydrochloride; Selective Estrogen Receptor Modulators; Ultrasonography; Uterine Neoplasms

To compare the efficacy and safety of Bravelle s.c., Bravelle i.m., and Follistim s.c. in patients undergoing controlled ovarian hyperstimulation for IVF-ET.. Open-label, randomized, parallel group, multicenter study.. Eleven academic and private fertility clinics with experience in IVF-ET.. Infertile premenopausal women with regular ovulatory menstrual cycles undergoing IVF-ET.. Down-regulation with leuprolide acetate followed by up to 12 days of Bravelle s.c. (n = 60), Bravelle i.m. (n = 59), or Follistim s.c. (n = 58); hCG administration, oocyte retrieval, and ET.. Mean number of oocytes retrieved; patients with ET, chemical, clinical and continuing pregnancies; mean peak serum E2 levels; adverse events and injection site pain scores.. There were no significant differences among treatment groups in mean number of oocytes retrieved, peak serum E2 levels, patients with ET, continuing pregnancies, or live births. There were no significant differences among the treatment groups in the number, nature, or intensity of adverse events. Patients treated with Bravelle s.c. or Bravelle i.m. experienced significantly less injection site pain than patients treated with Follistim s.c.. Bravelle s.c. and Bravelle i.m. are comparable in efficacy and safety to Follistim s.c. in patients undergoing controlled ovarian hyperstimulation for IVF-ET.

Topics: Adult; Embryo Transfer; Female; Fertilization in Vitro; Follicle Stimulating Hormone; Hormones; Humans; Injections, Intramuscular; Injections, Subcutaneous; Leuprolide; Ovulation Induction; Pain; Protein Isoforms; Recombinant Proteins; Safety

The purpose of this study was a quantification of changes in endometriosis-associated pain and quality of life during the stimulatory phase of gonadotropin-releasing hormone agonist therapy.. One hundred twenty women with significant endometriosis-associated pain participated in a 1-month double-blind, randomized, placebo-controlled trial. Pain was measured at baseline and at 2 and 4 weeks with visual analog scales and the Endometriosis Symptom Severity score. Quality of life was measured with the SF-36 instrument. Group means and SEMs were calculated. Paired t tests were used after determination of data normality.. Compared with placebo-treated control subjects women treated with gonadotropin-releasing hormone agonist had a statistically (P <. 0001) and clinically significant temporary increase in pain and a concomitant decrease in quality of life.. The stimulatory phase of gonadotropin-releasing hormone agonist therapy is associated with an increase in endometriosis-associated pain and a decrease in quality of life.

Topics: Adolescent; Adult; Double-Blind Method; Endometriosis; Female; Gonadotropin-Releasing Hormone; Humans; Leuprolide; Pain; Prospective Studies; Quality of Life

To examine the impact of treating endometriosis with nafarelin or leuprolide acetate depot on patient quality of life (QOL) and subjective clinical measures.. A randomized, multicenter study was conducted on 192 women with endometriosis. Patients received nafarelin or leuprolide for six months and were followed for up to six months after treatment. QOL was defined by seven items, including symptom severity, daily activities, pain medication use and need for bed rest.. No significant differences were found at baseline between treatments for patients with mild, moderate or no endometriosis symptoms. Those with severe symptoms of endometriosis at baseline and taking nafarelin had a significantly greater improvement in QOL at the last posttreatment visit than those receiving leuprolide (P < .01). Nafarelin was associated with significantly fewer days with moderate or severe hot flashes than leuprolide during treatment (P < .05) and with significantly fewer moderate or severe hypoestrogenic symptoms overall at three months of treatment (P < .05). Additionally, poorer QOL was significantly associated with hypoestrogenic and endometriosis symptoms.. Treatment of endometriosis with nafarelin was associated with fewer days of moderate or severe hot flashes as compared to leuprolide and with greater improvement in QOL after treatment in patients with severe symptoms at baseline.

Topics: Adult; Analgesics; Bed Rest; Endometriosis; Female; Fertility Agents, Female; Hormones; Hot Flashes; Humans; Leuprolide; Middle Aged; Nafarelin; Pain; Quality of Life; Severity of Illness Index; Treatment Outcome

An open-label randomized pilot study was conducted to evaluate the efficacy and acceptability of 6 months treatment with leuprolide in a 3-monthly versus a monthly i.m. depot injection for the relief of chronic pelvic pain in women with endometriosis. A total of 30 women aged 18-38 years were allocated to the 3-monthly depot arm (n = 15) or to the monthly depot arm (n = 15) after laparoscopic diagnosis of pelvic endometriosis. Mean (SD) deep dyspareunia scores according to a 0-3 point verbal rating scale decreased from 1.8 (0.9) at baseline to 1.3 (0.7) at the end of treatment in the 3-monthly depot group and from 2.1 (1.2) to 1.3 (0.7) in the monthly depot group. Corresponding values in non-menstrual pain scores fell from 2.1 (0.6) to 1.1 (0.3), and from 2.1 (0.8) to 1.2 (0.4) respectively, without statistically significant differences between the groups. Serum luteinizing hormone (LH) and 17 beta-oestradiol concentrations were significantly suppressed at 12 and 24 weeks compared with baseline values, without differences between the groups. The monthly depot caused a slightly more marked inhibition of serum follicle stimulating hormone (FSH) levels with respect to the 3-monthly preparation. Mean (SD) endometriosis scores at baseline and at 6-month follow-up laparoscopy were respectively 32.8 (25.1) and 12.2 (9.3) in the 3-monthly depot group and 29.0 (22.7) and 13.1 (15.3) in the monthly depot group (paired t-test, P < 0.05). Mean percentage decrease in lumbar spine bone mineral density was 5.2% in the former and 4.9% in the latter subjects. In the 3-monthly depot group, 13 women graded the tolerability of their treatment schedule as "good' compared with seven in the monthly depot group (chi 2 = 5.40, P = 0.02).

Topics: Adolescent; Adult; Dyspareunia; Endometriosis; Estradiol; Female; Follicle Stimulating Hormone; Humans; Leuprolide; Luteinizing Hormone; Pain; Pilot Projects

The hypoestrogenic state induced by gonadotropin-releasing hormone agonists (GnRHa) has been shown to suppress symptomatic endometriosis effectively but to elicit vasomotor symptoms and loss of bone mineral density. The role of norethindrone as a supplement to GnRHa in eliminating such side effects was assessed by enrolling 20 patients with symptomatic endometriosis diagnosed laparoscopically in a randomized, prospective, double-blinded trial. All patients received the long-acting GnRHa leuprolide acetate 3.75 mg im every 4 weeks for 24 weeks. Ten patients self-administered norethindrone 5 then 10 mg by mouth daily, whereas the remainder self-administered placebo tablets. Results of this study showed that combination therapy was as effective as GnRHa alone in significantly reducing circulating gonadotropin and estrogen levels (P less than 0.01), extent of visible endometriotic implants (P less than 0.01), and painful symptoms (P less than 0.01). Marked vasomotor and vaginal symptoms experienced by patients given GnRHa alone were minimized in those receiving GnRHa with norethindrone. Lumbar spine bone mineral density loss, measured by dual energy x-ray absorptiometry, was significantly reduced and more completely reversed in patients receiving combination therapy (P less than 0.05). A reversible decrease in high density lipoprotein-cholesterol and increase in low density lipoprotein:high density lipoprotein ratio was noted only in the patients receiving combination therapy, but not in those receiving GnRHa only. The addition of norethindrone to GnRHa is an effective means of treating symptomatic endometriosis while ameliorating side effects induced by GnRHa alone.

Topics: Bone Density; Drug Combinations; Endometriosis; Female; Gonadotropin-Releasing Hormone; Humans; Laparoscopy; Leuprolide; Lumbosacral Region; Norethindrone; Pain; Prospective Studies; Spine; Vasomotor System

The safety and efficacy of leuprolide acetate (LA) for depot suspension (Lupron depot; TAP Pharmaceuticals, North Chicago, IL), 3.75 mg versus placebo, in the treatment of pain associated with endometriosis was assessed in a randomized, double-blind, multicenter study involving 52 patients. Dysmenorrhea, pelvic pain, and pelvic tenderness all responded significantly to LA treatment in comparison with placebo. Menses were suppressed in all of the LA patients. Estradiol decreased significantly to menopausal levels in the LA group. There were small to moderate changes in a variety of laboratory parameters, but these were not clinically significant. The most common adverse event was vasodilatation, occurring significantly more frequently in the LA group. Lupron depot was shown to be safe and effective in inducing a hormonal and menstrual suppression in patients with endometriosis, resulting in alleviation of pain symptoms.

Topics: Adult; Antineoplastic Agents; Delayed-Action Preparations; Double-Blind Method; Endometriosis; Female; Follow-Up Studies; Gonadotropin-Releasing Hormone; Humans; Leuprolide; Multicenter Studies as Topic; Pain; Randomized Controlled Trials as Topic

We evaluated elagolix and leuprolide from the patient's perspective for the treatment of endometriosis-related pain.. Preference weights from a published discrete choice experiment were used to evaluate preferences for treatment profiles simulating elagolix (150 mg/day and 200 mg/twice-daily dosages) and leuprolide for the treatment of moderate to severe endometriosis-related pain. Sensitivity analyses were conducted by varying the range of risk for pregnancy-related problems, moderate to severe hot flashes, and bone fracture across scenarios.. The 200 mg twice daily dosage of elagolix is more likely to be preferred over leuprolide by patients with moderate to severe endometriosis-related pain in all scenarios explored in the evaluation and sensitivity analyses. The probability that an average respondent would select a treatment was sensitive to increases in risk of moderate to severe hot flashes for leuprolide and possible variations in the risk of pregnancy-related problems for both treatments but was not influenced by an increased risk of bone fracture.. Patients' preferences for treatment of endometriosis-related pain should be evaluated using the benefits and risks of each pharmacological option. Respondents were more likely to prefer the treatment profile similar to 200 mg twice daily elagolix over that of leuprolide in all scenarios.

Topics: Adolescent; Adult; Choice Behavior; Endometriosis; Female; Humans; Hydrocarbons, Fluorinated; Leuprolide; Middle Aged; Pain; Patient Preference; Pregnancy; Pregnancy Complications; Pyrimidines; Severity of Illness Index; Surveys and Questionnaires; United States; Young Adult

Autoimmune estrogen dermatitis is a cyclical cutaneous eruption that occurs premenstrually and goes to the rapid resolution within a few days of menstrual cycles. The disorder has variable clinical manifestations consisting of macules, papules, vesicles, urticarial lesions, bullae, eczematous plaques, and erythema multiforme-like lesions. Herein, we present a case of a 30-year-old woman with attacks of edema and erosions involving the oral and genital mucosal sites on every first day of her menstruation period. She had also multiple endocrinological problems such as hypotroidism and infertility. To determine the sex hormon sensitivity, intradermal skin tests were performed. Based on her personal history and skin test findings, a diagnosis of autoimmune estrogen dermatitis was made. After the oophorectomy, she was free from the skin and mucosal symptoms. We propose that it is important to suspect the diagnosis of autoimmune estrogen dermatitis in patients who present with recurrent cylic eruptions and it must be kept in mind that these patients might have a concomitant infertility.

Topics: Adult; Autoimmune Diseases; Biopsy; Dermatitis; Estrogen Antagonists; Estrogens; Female; Gonadotropin-Releasing Hormone; Humans; Hypothyroidism; Infertility; Leuprolide; Menstrual Cycle; Mouth Mucosa; Ovariectomy; Pain; Pruritus; Skin; Skin Tests; Tamoxifen

To clarify the effect of Pycnogenol (Horphag Research, Geneva, Switzerland), French maritime pine bark extract, on endometriosis.. Fifty-eight women were included in this study. They were operated on conservatively for endometriosis and surgically diagnosed with the condition. All patients were followed at 4, 12, 24 and 48 weeks after starting treatment to check for endometriosis signs and symptoms, including changes in CA-125 and estrogen levels (E2). Thirty-two patients in the Pycnogenol treatment group took 60 mg Pycnogenol orally a day for 48 weeks. The 26 patients who received gonadotropin-releasing hormone agonist (Gn-RHa) were treated in the standard way.. Treatment with Pycnogenol slowly but steadily reduced the symptom scores. Treatment with Gn-RHa reduced the scores more efficiently; however, 24 weeks after the end of treatment, the scores suggested a recurrence of signs. No influence of treatment on menstrual cycles or E2 was observed in the Pycnogenol group. CA-125 decreased in both treatment groups. Patients with smaller endometriomas responded better to treatment as compared to patients with larger endometriomas. In the Gn-RHa group, the lowering of CA-125 concentrations was far more pronounced; however, a clear rebound effect was observed.. Pycnogenol is a therapeutic alternative to Gn-RHa in the treatment of endometriosis.

Topics: Adjuvants, Immunologic; Adolescent; Adult; CA-125 Antigen; Dose-Response Relationship, Drug; Drug Administration Schedule; Endometriosis; Estrogens; Female; Fertility Agents, Female; Flavonoids; Follow-Up Studies; Humans; Leuprolide; Pain; Pain Measurement; Phytotherapy; Plant Extracts; Time Factors

This study was undertaken to evaluate the effectiveness of a 6-month course of gonadotropin-releasing hormone agonist treatment for patients with symptomatic endometriosis of the rectovaginal septum.. Fifteen patients with rectovaginal endometriosis and moderate to severe pain symptoms were the subjects of the study. None of these patients had either clinical or objective evidence of ovarian endometriosis, nor was there evidence of any obstructive lesions of the intestine or ureters. All patients were given leuprolide acetate depot at 3.75 mg, 1 ampule intramuscularly every 28 days, and treatment had a planned duration of 6 months. Follow-up evaluations were set every 2 months during the treatment phase and every 3 months thereafter until the completion of 1 year after discontinuation of medical therapy. At each follow-up visit pain symptoms were recorded, and clinical exploration, transvaginal ultrasonography, and transrectal ultrasonography were performed.. Two patients stopped the treatment early after the second and fourth leuprolide doses; in both cases the reason was persistence of pain, and both requested a surgical solution. The other 13 patients showed a marked improvement with respect to pain during the 6-month treatment course but had early pain recurrence after drug suspension; 11 of them required further treatment within the first year of follow-up. The failure rate of gonadotropin-releasing hormone agonist therapy to produce 1-year pain relief after treatment discontinuation was 87% (13/15) on an intent-to-treat basis. The endometriotic lesions showed a slight but significant reduction in size during therapy but had returned to the original volume within 6 months after cessation of the gonadotropin-releasing hormone analog treatment.. Our results suggest that gonadotropin-releasing hormone analogs should not be considered a real therapeutic alternative to surgical treatment for patients with symptomatic endometriosis of the rectovaginal septum, except possibly in a limited and unpredictable number of cases.

Topics: Adult; Endometriosis; Female; Gonadotropin-Releasing Hormone; Humans; Leuprolide; Pain; Rectal Diseases; Treatment Failure; Ultrasonography; Vaginal Diseases

Laparoscopy is the most frequent surgical approach in gynecologic patients with acute or chronic pelvic pain. The symptomatology is frequently related to a specific gynecological pathology such as endometriosis or associated adhesive disease. During an eight year period, January 1990 to December 1997, 26 patients (aged 16-20 years) with endometriosis were diagnosed endoscopically and managed pharmaceutically in our clinic. The disease was evaluated and staged according to the American Society of Reproductive Medicine. The disease was evaluated as first stage in 16 patients (61.6%), as second stage in eight patients (30.8%), as third stage in one patient (3.8%) and as fourth stage in one patient (3.8%). Patients underwent adhesiolysis and management according to their laparoscopic findings. Postoperative pharmaceutical treatment (Danazol, GnRH analogues, Oral Contraceptives) was given. Patients were followed for the evaluation of the treatment. The efficacy of the combination of endoscopic and pharmaceutical management of the disease is discussed.

Topics: Adolescent; Adult; Antineoplastic Agents, Hormonal; Ascitic Fluid; Contraceptives, Oral; Danazol; Disease Management; Electrocoagulation; Endometriosis; Estrogen Antagonists; Evaluation Studies as Topic; Female; Humans; Laparoscopy; Leuprolide; Pain; Tissue Adhesions; Treatment Outcome

To assess the efficacy and diagnostic value of GnRH agonist (GnRH-a) therapy in cases of hidden sciatic nerve endometriosis.. Case report.. Academic tertiary referral center for endometriosis treatment.. Three patients with cyclic, catamenial sciatica associated with pelvic endometriosis who had electromyographic evidence of sciatic nerve damage but negative computed tomography and magnetic resonance imaging findings.. Monthly administration of the GnRH-a leuprolide acetate plus daily transdermal E2 (25 microg).. Relief of pain symptoms and improvement in motor function.. All three patients had clear decreases in pain and partial amelioration of claudication.. Endometriosis of the sciatic nerve may be hard to diagnose with the use of current imaging techniques but may be proved by clinical response to GnRH analogue treatment and may be more frequent than previously thought.

Topics: Administration, Cutaneous; Adult; Drug Administration Schedule; Electromyography; Endometriosis; Estradiol; Female; Gonadotropin-Releasing Hormone; Humans; Leuprolide; Magnetic Resonance Imaging; Movement; Pain; Palliative Care; Peripheral Nervous System Diseases; Sciatic Nerve; Tomography, X-Ray Computed

A follow-up study was conducted to determine the emotional and medical responses of anonymous ovum donors to participation in an ovum donation procedure. Medically, donors reported significant discomfort, particularly relating to bloating, immediately prior to retrieval and for a brief period following retrieval. However, donors indicated that these effects no longer persisted at the time of follow-up. They also mentioned how unusual and initially anxiety-arousing it was to be in charge of their own injections. Few donors reported serious adverse emotional responses; many reported positive emotional responses to participation. Donors felt proud of their contribution, talked about their participation with friends and relatives, would be willing to participate again and would recommend ovum donation to other women. However, since the sample included only 43% of the 74 women who donated, caution is necessary in generalizing from the results of our study.

Topics: Confidentiality; Emotions; Female; Follow-Up Studies; Humans; Injections; Leuprolide; Oocyte Donation; Pain; Self Administration; Surveys and Questionnaires; Tissue Donors

To evaluate the safety and efficacy of leuprolide acetate depot (LA, Lupron; TAP Pharmaceuticals, Deerfield, IL) plus daily conjugated equine estrogens (Es, Premarin; Wyeth-Ayerst Laboratories, Philadelphia, PA), and medroxyprogesterone acetate (MPA, Provera; The Upjohn Company, Kalamazoo, MI) "add-back" treatment of endometriosis-associated pelvic pain.. Retrospective case series.. Tertiary care, academic medical center.. Eight patients with moderate to severe pelvic pain and laparoscopically documented endometriosis.. Leuprolide acetate depot 3.75 mg IM every 4 weeks for 24 months. Oral conjugated equine Es 0.625 mg/d plus MPA 2.5 mg/d were also taken from treatment months 3 through 24.. Six women completed the 2-year study. Mean revised endometriosis scores for implants, adhesions, and total values were significantly reduced at the conclusion of treatment from pretreatment scores. Self-reported pelvic pain scores were significantly lower at treatment months 3, 6, 12, 18, 24, and 6 months after therapy than pretreatment scores. Dual X-ray absorptiometry bone density measurements of the lumbar spine did not change significantly during the 24-month treatment period. The proportion of women experiencing hot flushes was significantly reduced after E-progestin add-back treatment from the proportion at treatment month 3.. Treatment with LA depot plus conjugated equine Es and MPA for 2 years was a safe and effective therapy for women with endometriosis and pelvic pain in this small retrospective study.

Topics: Adult; Bone Density; Drug Implants; Endometriosis; Estrogens; Female; Humans; Leuprolide; Menstruation; Pain; Pelvis; Progestins

Common manifestations of metastatic carcinoma of the prostate are bone pain, spinal cord compression, and disseminated intravascular coagulation. Prostate-specific antigen represents a useful marker to monitor tumor progression and response to therapy. Until recently, no therapy was available to prolong survival in these patients. Now, the use of a luteinizing hormone-releasing hormone agonist (leuprolide acetate [Lupron]) plus an antiandrogen (flutamide [Eulexin]) to provide total androgen blockade has demonstrated a 25% increase in survival time.

Topics: Antigens, Neoplasm; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Disseminated Intravascular Coagulation; Flutamide; Gonadotropin-Releasing Hormone; Humans; Leuprolide; Male; Pain; Prognosis; Prostate-Specific Antigen; Prostatic Neoplasms; Spinal Cord Compression