leuprolide and Pelvic-Pain

Endometriosis is a common chronic gynecological disease defined as the presence of endometrial glands and stroma tissue outside the uterus. Gestrinone is an effective antiestrogen that induces endometrial atrophy and/or amenorrhea. The purpose of this systematic review is to provide an evaluation of safety and effectiveness of gestrinone for the treatment of endometriosis.. We performed a search in six electronic databases: PubMed, MEDLINE (ovid), Embase, Cochrane CENTRAL (clinical trials), Web of Science and Scopus. Our selected primary outcomes were the changes in dysmenorrhea, pain relief including pelvic pain and dyspareunia. The secondary outcomes embrace hormones parameters, pregnancy rate and adverse events.. Of 3269 references screened, 16 studies were included involving 1286 women. All studies compared gestrinone with other drugs treatments (placebo, Danazol, Mifepristone tablets, Leuprolide acetate, Quyu Jiedu Recipe) during 6 months. When compared with other drugs treatments, gestrinone relieved dysmenorrhea, pelvic pain, and morphologic response in the ovary. There was an increase on the pregnancy rate. Regarding the side effects observed, gestrinone showed the same adverse events and increased the risk of acne and seborrhea when compared to other treatments. Even if there was any difference in efficacy between gestrinone, danazol, leuprolide acetate, or Quyu Jiedu Recipe Chinese Medicine, it remains unclear due to insufficient data.. Based limited evidence available suggests that gestrinone appeared to be safe and may have some efficacy advantages over danazol, as well as other therapeutic interventions for treating endometriosis. However, this conclusion should be interpreted with caution, due the quality of the evidence provided is generally very low or unclear.. CRD42021284148.

Topics: Danazol; Dysmenorrhea; Endometriosis; Female; Gestrinone; Humans; Leuprolide; Pelvic Pain; Pregnancy

The most common location of extragenital endometriosis is the bowel. Medical treatment may not provide long-term improvement in patients who are symptomatic, and consequently most of these patients may require surgical intervention. Over the past century, surgeons have continued to debate the optimal surgical approach to treating bowel endometriosis, weighing the risks against the benefits. In this expert review we will describe how the recommended surgical approach depends largely on the location of disease, in addition to size and depth of the lesion. For lesions approximately 5-8 cm from the anal verge, we encourage conservative surgical management over resection to decrease the risk of short- and long-term complications.

Topics: Anal Canal; Conservative Treatment; Contraceptives, Oral, Combined; Danazol; Digestive System Surgical Procedures; Endometriosis; Endosonography; Estrogen Antagonists; Female; Humans; Intestinal Diseases; Laparoscopy; Leuprolide; Magnetic Resonance Imaging; Ovulation Inhibition; Pelvic Pain; Postoperative Complications; Progestins; Rectal Diseases; Ultrasonography

Uterine fibroids are smooth muscle tumours arising from the uterus. These tumours, although benign, are commonly associated with abnormal uterine bleeding, bulk symptoms and reproductive dysfunction. The importance of progesterone in fibroid pathogenesis supports selective progesterone receptor modulators (SPRMs) as effective treatment. Both biochemical and clinical evidence suggests that SPRMs may reduce fibroid growth and ameliorate symptoms. SPRMs can cause unique histological changes to the endometrium that are not related to cancer, are not precancerous and have been found to be benign and reversible. This review summarises randomised trials conducted to evaluate the effectiveness of SPRMs as a class of medication for treatment of individuals with fibroids.. To evaluate the effectiveness and safety of SPRMs for treatment of premenopausal women with uterine fibroids.. We searched the Specialised Register of the Cochrane Gynaecology and Fertility Group, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, PsycINFO, the Cumulative Index to Nursing and Allied Health Literature (CINAHL) and clinical trials registries from database inception to May 2016. We handsearched the reference lists of relevant articles and contacted experts in the field to request additional data.. Included studies were randomised controlled trials (RCTs) of premenopausal women with fibroids who were treated for at least three months with a SPRM.. Two review authors independently reviewed all eligible studies identified by the search. We extracted data and assessed risk of bias independently using standard forms. We analysed data using mean differences (MDs) or standardised mean differences (SMDs) for continuous data and odds ratios (ORs) for dichotomous data. We performed meta-analyses using the random-effects model. Our primary outcome was change in fibroid-related symptoms.. We included in the review 14 RCTs with a total of 1215 study participants. We could not extract complete data from three studies. We included in the meta-analysis 11 studies involving 1021 study participants: 685 received SPRMs and 336 were given a control intervention (placebo or leuprolide). Investigators evaluated three SPRMs: mifepristone (five studies), ulipristal acetate (four studies) and asoprisnil (two studies). The primary outcome was change in fibroid-related symptoms (symptom severity, health-related quality of life, abnormal uterine bleeding, pelvic pain). Adverse event reporting in the included studies was limited to SPRM-associated endometrial changes. More than half (8/14) of these studies were at low risk of bias in all domains. The most common limitation of the other studies was poor reporting of methods. The main limitation for the overall quality of evidence was potential publication bias. SPRM versus placebo SPRM treatment resulted in improvements in fibroid symptom severity (MD -20.04 points, 95% confidence interval (CI) -26.63 to -13.46; four RCTs, 171 women, I. Short-term use of SPRMs resulted in improved quality of life, reduced menstrual bleeding and higher rates of amenorrhoea than were seen with placebo. Thus, SPRMs may provide effective treatment for women with symptomatic fibroids. Evidence derived from one RCT showed no difference between leuprolide acetate and SPRM with respect to improved quality of life and bleeding symptoms. Evidence was insufficient to show whether effectiveness was different between SPRMs and leuprolide. Investigators more frequently observed SPRM-associated endometrial changes in women treated with SPRMs than in those treated with placebo or leuprolide acetate. As noted above, SPRM-associated endometrial changes are benign, are not related to cancer and are not precancerous. Reporting bias may impact the conclusion of this meta-analysis. Well-designed RCTs comparing SPRMs versus other treatments are needed.

Topics: Amenorrhea; Antineoplastic Agents, Hormonal; Estrenes; Female; Humans; Leiomyoma; Leuprolide; Menstruation; Mifepristone; Norpregnadienes; Oximes; Pelvic Pain; Quality of Life; Randomized Controlled Trials as Topic; Receptors, Progesterone; Uterine Neoplasms

To evaluate the role and efficacy of preventing bone mineral loss in patients with endometriosis treated by gonadotrophin-releasing hormone analogues (GnRH-a) combined with add-back therapy.. Prospective, randomized controlled studies of the use of GnRHa with add-back therapy in treatment of endometriosis were enrolled in this study from Medline, Embase, Cochrane library, China National Knowledge Internet (CNKI), Chinese Biological Medicine Disk (CBM) and Data Base of Wanfang.After quality assessment and data extraction, meta-analysis were conducted in the change of BMD, reproductive hormone (E2) and visual pain score(VAS) by Stata 11.0 software.. A total of 785 patients from 13 randomized controlled trail (RCT) studies enrolled in this study after exclude no following up, poor quality and repeat published studies.377 patients were in group of GnRH-a with add-back treatment and 408 patients were in group of GnRna alone.The findinds were showed in meta-analysis: (1) there was a significant difference in percentage change of bone mineral density (BMD) between two groups, the add-back therapy was more effective in prevention of bone loss which was (SMD = 0.223, 95%CI:0.003 to 0.443, P = 0.047). (2) There was no significant difference in the level of reproductive hormone between two groups (SMD = -0.053, 95% CI:-0.479 to 0.373, P = 0.807). (3) There was also no significant difference in the visual pain score between the two groups (SMD = -0.157, 95% CI: -0.474 to 0.160, P = 0.332).. GnRH-a with add-back therapy have been shown to be more effective in preventing loss of BMD than GnRH-a treatment alone.However, the long term effect of preventing BMD should be studied.

Topics: Bone Density; Drug Administration Schedule; Drug Therapy, Combination; Endometriosis; Estrogen Antagonists; Estrogens; Female; Gonadotropin-Releasing Hormone; Humans; Leuprolide; Lumbar Vertebrae; Pain Measurement; Pelvic Pain; Randomized Controlled Trials as Topic

Endometriosis is a chronic inflammatory condition defined by the presence of glands and stroma outside the uterine cavity. It occurs in 7% to 10% of all women of reproductive age and may present as pain or infertility. The pelvic pain may be in the form of dysmenorrhoea, dyspareunia or pelvic pain. Initially a combination of estrogens and progestagens was used to create a pseudopregnancy and alleviate the symptoms associated with endometriosis. Progestagens alone or anti-progestagens have been considered as alternatives because they are inexpensive and may have a better side effect profile than other choices.. To determine the effectiveness of both the progestagens and anti-progestagens in the treatment of painful symptoms ascribed to the diagnosis of endometriosis.. We used the search strategy of the Menstrual Disorders and Subfertility Group to identify all publications which described or might have described randomised controlled trials (RCTs) of any progestagen or any anti-progestagen in the treatment of symptomatic endometriosis. We updated the review in 2011.. We considered only RCTs which compared the use of progestagens and anti-progestagens with other interventions, placebo or no treatment for the alleviation of symptomatic endometriosis.. We have added six new studies, bringing the total of included studies to 13 in the update of this review. The six newly included studies evaluated progestagens (comparisons with placebo, danazol, oral or subdermal contraceptive, oral contraceptive pill and danazol, gonadotrophin-releasing hormone (GnRH) analogue and other drugs). The remaining studies compared the anti-progestagen gestrinone with danazol, GnRH analogues or itself.. The progestagen medroxyprogesterone acetate (100 mg daily) appeared to be more effective at reducing all symptoms up to 12 months of follow-up (MD -0.70, 95% CI -8.61 to -5.39; P < 0.00001) compared with placebo. There was evidence of significantly more cases of acne (six versus one) and oedema (11 versus one) in the medroxyprogesterone acetate group compared with placebo. There was no evidence of a difference in objective efficacy between dydrogesterone and placebo.There was no evidence of a benefit with depot administration of progestagens versus other treatments (low dose oral contraceptive or leuprolide acetate) for reduced symptoms. The depot progestagen group experienced significantly more adverse effects.There was no overall evidence of a benefit of oral progestagens over other medical treatment at six months of follow-up for self-reported efficacy. Amenorrhoea and bleeding were more frequently reported in the progestagen group compared with other treatment groups.There was no evidence of a benefit of anti-progestagens (gestrinone) compared with danazol. GnRH analogue (leuprorelin) was found to significantly improve dysmenorrhoea compared with gestrinone (MD 0.82, 95% CI 0.15 to 1.49; P = 0.02) although it was also associated with increased hot flushes (OR 0.20, 95% CI 0.06 to -0.63; P = 0.006).. There is only limited evidence to support the use of progestagens and anti-progestagens for pain associated with endometriosis.

Topics: Danazol; Dydrogesterone; Endometriosis; Female; Gestrinone; Gonadotropin-Releasing Hormone; Humans; Leuprolide; Medroxyprogesterone Acetate; Pelvic Pain; Progesterone Congeners; Progestins

Chronic pelvic pain is a condition that affects one in seven women of reproductive age in the United States. Direct and indirect medical costs associated with this condition are estimated to be more than $3 billion annually before factoring in the costs of diagnostic testing. At many medical centers, endometriosis is the most common single cause of chronic pelvic pain; other causes include intra-abdominal adhesions, chronic pelvic inflammatory disease, ovarian cysts, and adenomyosis. The current approach to diagnosis and treatment of chronic pelvic pain is a two-step approach, with medical history, physical examination, laboratory testing, and empiric therapy (nonsteroidal anti-inflammatory drugs, oral contraceptives, and/or antibiotics) comprising Step 1 and surgical diagnosis with laparoscopy as Step 2. At many centers, the most common diagnosis at the time of laparoscopy for chronic pelvic pain is endometriosis, typically minimal to mild disease that can be effectively treated with hormonal therapy. Therefore, a rational alternative approach is a 3-month empiric course of therapy with a gonadotropin-releasing hormone agonist before laparoscopy. The advantages of this approach are the high rate of pain relief in women, the possibility of avoiding an invasive procedure (laparoscopy), the ability to extend therapy, if pain is relieved, to the full 6-month therapeutic course of endometriosis, and a potentially lower cost relative to laparoscopy.

Topics: Chronic Disease; Cost of Illness; Endometriosis; Female; Hormone Antagonists; Humans; Laparoscopy; Leuprolide; Managed Care Programs; Pelvic Pain; United States

To evaluate the efficacy and safety of 40-mg relugolix (REL) compared with those of leuprorelin (LEU) in women with endometriosis-associated pain.. Phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled study in Japanese patients.. Hospitals and clinics.. Women aged ≥20 years with regular menstrual cycles (25-38 days) experiencing endometriosis or ovarian endometrioma and reporting pelvic pain.. In the REL group, 40 mg of REL was orally administered once a day for 24 weeks. In the LEU group, 3.75 or 1.88 mg of LEU was subcutaneously injected every 4 weeks for 24 weeks.. The primary endpoint was the change in the maximum visual analog scale score for pelvic pain from baseline until 28 days before the end of treatment.. Changes in the maximum visual analog scale score were -52.6 ± 1.3 for REL and -57.5 ± 1.4 for LEU. Ovarian endometrioma decreased by 12.26 ± 17.52 cm. Relugolix was noninferior to LEU for treating endometriosis-associated pelvic pain. Safety profiles of both medications were comparable, although menses returned earlier in patients taking REL, a huge benefit for women who plan to conceive after treatment.. ClinicalTrials.gov: NCT03931915.

Topics: Administration, Oral; Adult; Double-Blind Method; Endometriosis; Female; Fertility Agents, Female; Follow-Up Studies; Hormone Antagonists; Humans; Japan; Leuprolide; Pain Measurement; Pelvic Pain; Phenylurea Compounds; Pyrimidinones; Receptors, LHRH

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

Relugolix is a once-daily, oral, nonpeptide, gonadotropin-releasing hormone receptor antagonist. The aim of this study was to evaluate safety of relugolix over 24 weeks in women with endometriosis-associated pain.. This phase 2, randomized, open-label, parallel-group extension study was conducted in 101 clinics in Japan. Patients (premenopausal females ≥ 20 years) who completed the preceding 12-week relugolix phase 2 study continued to receive relugolix (10 mg, 20 mg, or 40 mg), placebo, or leuprorelin (3.75 mg) for an additional 12 weeks. Relugolix was administered orally once daily, and leuprorelin subcutaneously once every 4 weeks. The primary outcome was safety, including bone mineral density (BMD) and treatment-emergent adverse events (TEAEs). Secondary endpoints included visual analog scale (VAS) scores for endometriosis-associated pain. Analysis sets were defined as all patients who were administered the study drug.. Of 487 randomized patients in the preceding study, 397 enrolled in this extension study and continued to receive placebo (n = 77), relugolix 10 mg (n = 84), relugolix 20 mg (n = 78), relugolix 40 mg (n = 89), or leuprorelin (n = 69). Baseline characteristics were similar between extension study patients and patients in the preceding study. Frequency of TEAEs including metrorrhagia, menorrhagia, and hot flush was similar in the relugolix 40-mg and leuprorelin groups. Mean (SD) change in BMD from baseline at Week 24 was - 0.2 (1.99)% for placebo;  - 1.6 (2.34)%,  - 2.6 (2.94)%, and  - 4.9 (2.91)% for the relugolix 10-mg, 20-mg, and 40-mg groups, respectively; and - 4.4 (2.16)% for leuprorelin. Mean ± SD change from baseline in mean VAS score (mm) for pelvic pain at end of treatment was - 3.2 ± 12.16 for placebo; - 6.8 ± 10.56, - 9.0 ± 11.84, and - 11.9 ± 11.26 for the relugolix 10-mg, 20-mg, and 40-mg groups, respectively; and - 12.7 ± 12.57 for leuprorelin. Estradiol levels decreased with increasing relugolix dose and remained below postmenopausal levels throughout the 24-week relugolix 40-mg treatment period.. Treatment with relugolix for 24 weeks was generally well tolerated and demonstrated similar pain reduction to leuprorelin in women with endometriosis. The dose-dependent loss in BMD observed with relugolix treatment was expected due to an induced hypoestrogenic state. Relugolix demonstrated a similar benefit/risk profile to injectable therapy in this phase 2 study. Trial registration NCT01452685 (ClinicalTrials.gov, registered 17/10/2011).

Topics: Double-Blind Method; Endometriosis; Female; Humans; Japan; Leuprolide; Pelvic Pain; Phenylurea Compounds; Pyrimidinones; Treatment Outcome

Does the GnRH antagonist, ASP1707, reduce endometriosis-associated pelvic pain?. ASP1707 significantly reduced endometriosis-associated pelvic pain in a dose-related manner.. GnRH agonists are an effective therapeutic option for endometriosis that is refractory to non-steroidal anti-inflammatory drugs, oral contraceptives, and progestins. However, GnRH agonists cause complete suppression of estradiol (E2), resulting in hypoestrogenic side-effects such as bone loss that may increase the future risk of osteoporotic fractures.. This was a Phase II, multicenter, double-blind, randomized, parallel-group, placebo-controlled study conducted in 540 women from 04 December 2012 to 30 July 2015 in Europe and Japan. A sample size of 504 (84 subjects per group) was calculated to provide ≥80% power to detect a dose-related treatment effect among placebo and ASP1707 doses in change from baseline in pelvic pain, assuming different dose-response curves after 12 weeks of treatment.. Of 912 women with endometriosis-associated pelvic pain screened, 540 were enrolled, and 532 received ≥1 dose of study drug (placebo, n = 88; ASP1707 3 mg, n = 86; ASP1707 5 mg, n = 91; ASP1707 10 mg, n = 90; ASP1707 15 mg, n = 88; leuprorelin, n = 89) for 24 weeks.. After 12 weeks of treatment with ASP1707, the mean (95% CI) changes in numeric rating score (NRS) for overall pelvic pain (OPP) were -1.56 (-1.91, -1.21), -1.63 (-1.99, -1.27), -1.93 (-2.27, -1.60), -2.29 (-2.64, -1.94), and -2.13 (-2.47, -1.79) for placebo, ASP1707 3 mg, ASP1707 5 mg, ASP1707 10 mg, and ASP1707 15 mg, respectively. Mean (95% CI) changes in NRS for dysmenorrhea were -1.50 (-2.00, -1.00), -2.72 (-3.22, -2.21), -2.85 (-3.33, -2.38), -3.97 (-4.46, -3.48), and -4.18 (-4.66, -3.70), respectively. Mean (95% CI) changes in NRS for non-menstrual pelvic pain (NMPP) were -1.53 (-1.88, -1.19), -1.51 (-1.87, -1.16), -1.80 (-2.14, -1.47), -2.03 (-2.37, -1.68), and -1.86 (-2.20, -1.52), respectively. Statistically significant dose-related treatment effects in reduction in NRS for OPP (P = 0.001), dysmenorrhea (P < 0.001), and NMPP (P = 0.029) were observed after 12 weeks among ASP1707 doses and were maintained through 24 weeks. Serum estradiol and bone mineral density decreased dose dependently with ASP1707 through 24 weeks, however, to a lesser extent than with leuprorelin.. This study was not powered for pairwise comparison of each ASP1707 group versus placebo.. All doses of ASP1707 reduced serum E2 levels to within the target range and to a lesser extent than leuprorelin. ASP1707 is a potential alternative treatment to leuprorelin for endometriosis-associated pelvic pain with lower impact on bone health.. This study was funded by Astellas Pharma Inc. T.D'.H is Vice President and Head of Global Medical Affairs Fertility at Merck, Darmstadt, Germany since October 1, 2015. At the time that the TERRA study was conducted, he served as Principal Investigator in his role as Coordinator of the Leuven University Fertility Center. Since October 2015, T.D'.H has left Leuven University Hospital Gasthuisberg, but continues to serve as Professor in Reproductive Medicine and Biology at KU Leuven (University of Leuven) Belgium and at the Dept of Obstetrics, Gynecology and Reproduction at Yale University, New Haven, USA. T. Fukaya and Y. Osuga report personal consulting fees from Astellas Pharma Inc. during the conduct of the study and outside the submitted work. G.M. Holtkamp, and L. Skillern are employed by Astellas Pharma Europe B.V.; K. Miyazaki is employed by Astellas Pharma Inc.; B. López, was a biostatistician for Astellas Pharma Europe B.V. during conduct of the study; R. Besuyen was a contract Associate Director of Medical Science for Astellas during conduct of the study.. ClinicalTrials.gov, www.clinicaltrials.gov, NCT01767090. EudraCT number 2012-002791-14.. 18 December 2012.. One subject signed informed consent on 04 December 2012; the first subject was randomized on 16 April 2013.

Topics: Administration, Oral; Adolescent; Adult; Dose-Response Relationship, Drug; Double-Blind Method; Endometriosis; Female; Hormone Antagonists; Humans; Imidazoles; Leuprolide; Middle Aged; Pain Measurement; Pelvic Pain; Receptors, LHRH; Sulfones; Treatment Outcome; Young Adult

To analyze the secondary efficacy and safety outcomes from a recent trial comparing dienogest (DNG) with leuprolide acetate (LA) in women with endometriosis.. A 24-week, open-label, randomized, multicenter study of DNG versus LA in women with endometriosis-related pain was assessed for outcomes such as responder rates (using predefined thresholds of pain relief), changes in single symptoms/signs and sum scores from the Biberoglu and Behrman (B&B) scale, clinical laboratory parameters, and measures of quality of life.. Dienogest was non-inferior to LA for treatment response using all predefined thresholds of pain relief and provided equivalent improvements in B&B symptoms and signs. No clinically relevant changes in laboratory parameters were observed during DNG treatment, whereas estrogen levels decreased in the LA group. Compared with LA, DNG was associated with pronounced improvements in specific quality-of-life measures.. The analyses provide supportive evidence that the efficacy of DNG is equivalent to that of LA for treating endometriosis symptoms, with specific quality-of-life benefits and a favorable safety profile.

Topics: Adolescent; Adult; Antineoplastic Agents, Hormonal; Dysmenorrhea; Endometriosis; Estrogens; Female; Humans; Leuprolide; Middle Aged; Nandrolone; Pelvic Pain; Quality of Life; Severity of Illness Index; Surveys and Questionnaires; Young Adult

To compare the efficacy of leuprolide and continuous oral contraceptives in the treatment of endometriosis-associated pain.. Prospective, randomized, double-blind controlled trial.. Academic medical centers in Rochester, New York, and Boston, Massachusetts.. Forty-seven women with endometriosis-associated pelvic pain.. Forty-eight weeks of either depot leuprolide, 11.25 mg IM every 12 weeks with hormonal add-back using norethindrone acetate 5 mg orally, daily; or a generic monophasic oral contraceptive (1 mg norethindrone + 35 mg ethinyl estradiol) given daily.. Biberoglu and Behrman (B&B) pain scores, numerical rating scores (NRS), Beck Depression Inventory (BDI), and Index of Sexual Satisfaction (ISS).. Based on enrollment of 47 women randomized to continuous oral contraceptives and to leuprolide, there were statistically significant declines in B&B, NRS, and BDI scores from baseline in both groups. There were no significant differences, however, in the extent of reduction in these measures between the groups.. Leuprolide and continuous oral contraceptives appear to be equally effective in the treatment of endometriosis-associated pelvic pain.

Topics: Adult; Contraceptives, Oral, Hormonal; Double-Blind Method; Endometriosis; Female; Fertility Agents, Female; Humans; Leuprolide; Patient Satisfaction; Pelvic Pain; Peritoneal Diseases; Quality of Life; Sexuality; Young Adult

Dienogest is a selective progestin that has been investigated in a clinical trial programme for the treatment of endometriosis. The current non-inferiority trial compared the efficacy and safety of dienogest against leuprolide acetate (LA) for treating the pain associated with endometriosis.. Patients with confirmed endometriosis were randomized to treatment with dienogest (2 mg/day, orally) or LA (3.75 mg, depot i.m. injection, every 4 weeks) for 24 weeks. The primary efficacy variable was absolute change in pelvic pain from baseline to end of treatment, assessed by visual analogue scale (VAS). Safety variables included adverse event profile, laboratory parameters, bone mineral density (BMD), bone markers and bleeding patterns.. A total of 252 women were randomized to treatment with dienogest (n = 124) or LA (n = 128); 87.9 and 93.8% of the respective groups completed the trial. Absolute reductions in VAS score from baseline to Week 24 were 47.5 mm with dienogest and 46.0 mm with LA, demonstrating the equivalence of dienogest relative to LA. Hypoestrogenic effects (e.g. hot flushes) were reported less frequently in the dienogest group. As expected, bleeding episodes were suppressed less with dienogest than with LA. Changes in mean lumbar BMD between screening and final visit were +0.25% with dienogest and -4.04% with LA subgroups (P = 0.0003). Markers of bone resorption increased with LA but not dienogest.. Dienogest 2 mg/day orally demonstrated equivalent efficacy to depot LA at standard dose in relieving the pain associated with endometriosis, although offering advantages in safety and tolerability.

Topics: Adult; Bone Density; Endometriosis; Female; Humans; Leuprolide; Nandrolone; Pelvic Pain; Progestins; Quality of Life

A clinical study compared efficacy and safety of depot medroxyprogesterone acetate (DMPA) with leuprolide for endometriosis-associated pain.. This multicentre, 18 month, evaluator-blinded, comparator-controlled trial randomized 300 women with laparoscopically diagnosed endometriosis to 6 month treatment with subcutaneous injection of 104 mg/0.65 ml DMPA (DMPA-SC 104) every 3 months or leuprolide (3.75 mg monthly or 11.25 mg every 3 months), with 12 months post-treatment follow-up. Endpoints included patient response to treatment in five signs/symptoms (dysmenorrhoea, dyspareunia, pelvic pain, pelvic tenderness, induration) and changes in bone mineral density (BMD) and productivity at 6 and 18 months.. DMPA-SC 104 and leuprolide produced equivalent (P < 0.02) reductions in at least four pain categories and significant (P < 0.001) improvements in composite score at months 6 and 18. At month 6, reductions in total hip and lumbar spine BMD were significantly less (P < 0.001) with DMPA-SC 104 versus leuprolide. BMD returned to pre-treatment levels 12 months post-treatment in the DMPA-SC 104 but not the leuprolide group. Total productivity also significantly (P < or = 0.05) improved in both groups at 6 and 18 months.. DMPA-SC 104 reduces endometriosis-associated pain as effectively as leuprolide and improves productivity with significantly less BMD decline.

Topics: Administration, Cutaneous; Adult; Antineoplastic Agents, Hormonal; Bone Density; Contraceptive Agents, Female; Endometriosis; Female; Fertility Agents, Female; Hip; Humans; Leuprolide; Lumbar Vertebrae; Medroxyprogesterone Acetate; Pelvic Pain; Quality of Life; Radiography; Treatment Outcome; Uterine Diseases

This pilot study examined the effect of a low-dose E and pulsed progestogen hormone therapy (HT) regimen for add-back during long-term GnRH-agonist therapy on bone mineral density (BMD) in five patients with stage IV endometriosis. Bone mineral density was stable after initiation of HT for the entire follow-up period (up to 10 years). One patient stopped her treatment on two occasions to conceive and was successful each time with delivery of a normal baby. No patient had return of pelvic pain after HT add-back.

Topics: Adult; Bone Demineralization, Pathologic; Bone Density; Chronic Disease; Drug Combinations; Endometriosis; Estradiol; Female; Fertility Agents, Female; Hormone Replacement Therapy; Humans; Leuprolide; Pelvic Pain; Pilot Projects; Progestins; Treatment Outcome

The objective of this multicentre randomized, controlled clinical trial was to compare the efficacy of a levonorgestrel-releasing intrauterine system (LNG-IUS) and a depot-GnRH-analogue in the control of endometriosis-related pain over a period of six months.. Eighty-two women, 18 to 40 years of age (mean 30 years), with endometriosis, dysmenorrhoea and/or CPP, were randomized using a computer-generated system of sealed envelopes into either LNG-IUS (n = 39) or GnRH analogue (n = 43) treatment groups at three university centres. Daily scores of endometriosis-associated CPP were evaluated using the Visual Analogue Scale (VAS), daily bleeding score was calculated from bleeding calendars, and improvement in quality of life was evaluated using the Psychological General Well-Being Index Questionnaire (PGWBI). The pain score diary was based on the VAS in which women recorded the occurrence and intensity of pain on a daily basis. A monthly score was calculated from the result of the sum of the daily scores divided by the number of days in each observation period.. CPP decreased significantly from the first month throughout the six months of therapy with both forms of treatment and there was no difference between the groups (P > 0.999). In both treatment groups, women with stage III and IV endometriosis showed a more rapid improvement in the VAS pain score than women with stage I and II of the disease (P < 0.002). LNG-IUS users had a higher bleeding score than GnRH-analogue users at all time points of observation with 34% and 71% of patients in the LNG-IUS and GnRH-analogue groups, respectively, reporting no bleeding during the first treatment month, and 70% and 98% reporting no bleeding during the sixth month. No difference was observed between groups with reference to improvement in quality of life.. Both, the LNG-IUS and the GnRH-analogue were effective in the treatment of CPP-associated endometriosis, although no differences were observed between the two treatments. Among the additional advantages of the LNG-IUS is the fact that it does not provoke hypoestrogenism and that it requires only one medical intervention for its introduction every 5 years. This device could therefore become the treatment of choice for CPP-associated endometriosis in women who do not wish to conceive.

Topics: Adolescent; Adult; Delayed-Action Preparations; Endometriosis; Female; Gonadotropin-Releasing Hormone; Humans; Intrauterine Devices, Medicated; Leuprolide; Levonorgestrel; Pelvic Pain

Endometriosis is thought to be an ovarian-dependent benign disease that affects up to 12% of women during their reproductive life. For the past ten years the gonadotropin-releasing hormone (GnRH)-agonists have been proved effective and safe drugs in the treatment of endometriosis. Nevertheless, gestagens such as lynestrenol still remain the most often used hormonal drugs for the treatment of this disease. The primary objective of this study was to compare the efficacy of the GnRH-agonist leuprorelin acetate depot (LAD) (Enantone-Gyn) 3.75 mg subcutaneously per month with that of the gestagen lynestrenol (LYN) (Orgametril) 5 mg orally twice per day in women with severe endometriosis, in terms of postoperative revised American Fertility Society (r-AFS) scores I-IV at first-look laparoscopy (score after removal of endometriotic lesions or adhesions) to the r-AFS score after six months' treatment. Secondary objectives were the improvement of clinical symptoms and the side-effect profile. Forty-eight women with postoperative r-AFS scores I-IV were evaluated in an open prospective randomized study between 1996 and 1998. All the participants underwent a first-look laparoscopy with resection of endometriotic lesions and six months' therapy with one of the above mentioned drugs, and a further second-look laparoscopy. The six months' treatment with LAD or LYN led to a significant reduction of the r-AFS score points in both groups. The mean r-AFS score in points for the LAD group after the first-look laparoscopy was 21.8 and was 27.2 for the LYN group. After the medical treatment a mean value of 11.5 points was observed in the LAD group compared with a mean value of 25.5 in the LYN group. This difference was statistically significant (p = 0.000014, Wilcoxon test). The improvement in the symptoms of dysmenorrhea, chronic pelvic pain and dyspareunia was also more pronounced in the LAD-treated group. LAD was more effective than LYN in the suppression of circulating serum 17 beta-estradiol levels after 6 months of treatment (mean 27.7 +/- 9.3 pg/ml versus 42.6 +/- 59.3 pg/ml). All the observed side-effects were deemed tolerable by the women who participated in this study. As the reduction of the r-AFS score in points was much more pronounced in the LAD group than in the LYN group, GnRH-agonists should therefore be used as first-choice drugs in the treatment of endometriosis. Due to the limited treatment of 6 months' duration of GnRH-agonists, gestagens might be used as

Topics: Adult; Delayed-Action Preparations; Dysmenorrhea; Dyspareunia; Endometriosis; Estradiol; Female; Fertility; Gonadotropin-Releasing Hormone; Humans; Laparoscopy; Leuprolide; Lynestrenol; Pelvic Pain; Progesterone; Progesterone Congeners; Prospective Studies; Second-Look Surgery

In order to decrease endometriosis recurrence after surgical therapy, it has been proposed to use a post-surgical oestrogen-lowering medical treatment. Results from previous trials on this topic are contradictory.. A total of 89 women were randomized, by computer-generated list, after laparoscopic conservative surgery for symptomatic endometriosis stage III-IV to receive monthly i.m. injections of gonadotrophin-releasing hormone (GnRH) analogue, leuprolide acetate depot (3.75 mg) for 3 months (n = 44) or to an expectant management (n = 45). All patients were followed up every 6 months for evaluation of pain symptoms, fertility and objective disease recurrence.. During the follow-up, which ranged from 6-36 months, five (33%) of the 15 women who wanted children and who were allocated the GnRH analogue and six (40%) of the 15 given no treatment became pregnant (not significant). Moderate/severe pelvic pain recurred during the follow-up in 10 (23%) of the women allocated the GnRH analogue and 11 (24%) of those allocated no treatment; the cumulative pain recurrence rates at 18 months were 23 and 29% respectively (not significant). Four women (9%) treated with GnRH analogue and four women (9%) who received no treatment had objective disease recurrence as demonstrated by gynaecological examination and/or pelvic ultrasonography.. This study does not support the routine post-operative use of a 3 month course of GnRH analogue in women with symptomatic endometriosis stage III-IV.

Topics: Adult; Delayed-Action Preparations; Dysmenorrhea; Dyspareunia; Endometriosis; Female; Humans; Leuprolide; Pelvic Pain; Postoperative Care; Pregnancy; Recurrence; Reoperation

Treatment of endometriosis with gonadotropin-releasing hormone agonists (GnRHa) is limited to 6 months because of possible adverse effects on bone metabolism. We designed a randomized, double-blind, placebo-controlled, prospective study of 27 patients with endometriosis who were given GnRHa with or without hormone add-back therapy (+ 20 microg of ethinyl estradiol with 0.15 mg desogestrel) designed to suppress the adverse effects of hypoestrogenism while preserving the efficacy of GnRHa. Both regimens showed significant improvements in endometriosis, dysmenorrhea, and pelvic pain; effects were significantly better in the GnRHa + placebo group. The GnRHa + placebo group had significantly higher serum calcium levels and a significantly higher loss of lumbar spine bone mineral density (BMD). Urinary levels of pyridinium crosslinks increased significantly in the GnRHa + placebo group, and declined to normal in the GnRHa + add-back group. The add-back therapy protects women taking GnRHas from severe loss of BMD and accelerated bone collagen resorption, but reduces the efficacy of the GnRHa.

Topics: Amino Acids; Bone Density; Calcium; Desogestrel; Double-Blind Method; Endometriosis; Ethinyl Estradiol; Female; Humans; Leuprolide; Pelvic Pain; Placebos; Prospective Studies

To evaluate and compare the safety and efficacy of leuprolide versus placebo in managing chronic pelvic pain in women with clinically suspected endometriosis.. Women 18-45 years of age with moderate to severe pelvic pain of at least 6 months' duration underwent extensive, noninvasive diagnostic testing and laboratory evaluation, including pelvic ultrasound, complete blood count, determination of erythrocyte sedimentation rate, and endocervical cultures. Those with clinically suspected endometriosis were randomized to double-blind treatment for 3 months with depot leuprolide (3.75 mg/mo) or placebo. The accuracy of the clinical diagnosis of endometriosis was evaluated by posttreatment laparoscopy.. Of 100 women randomized, 95 completed the study: 49 in the leuprolide group and 46 in the placebo group. Women in the leuprolide group had clinically and statistically significant (P < or = .001) mean improvements from baseline after 12 weeks of therapy in all pain measures. These mean improvements were significantly greater (P < or = .001) than those in the placebo group. At 12 weeks, mean decreases in physician-rated scores for dysmenorrhea, pelvic pain, and pelvic tenderness were 1.7, 1.0, and 0.8 points greater, respectively, in the leuprolide group than in the placebo group (on a four-point scale). Thirty-eight (78%) of 49 and 40 (87%) of 46 patients in the leuprolide and placebo groups, respectively, had laparoscopically confirmed endometriosis after 12 weeks of treatment. No women withdrew from the study because of adverse events.. Depot leuprolide was effective and safe for treating patients with chronic pelvic pain and clinically suspected endometriosis, confirming the potential of its empiric use in these patients.

Topics: Adolescent; Adult; Algorithms; Chronic Disease; Delayed-Action Preparations; Double-Blind Method; Endometriosis; Female; Humans; Laparoscopy; Leuprolide; Middle Aged; Pelvic Pain

To evaluate the efficacy and safety of a GnRH agonist, leuprolide acetate depot, alone and in combination with three hormonal add-back regimens in the management of endometriosis-associated pelvic pain.. Two hundred and one patients were enrolled in this multicenter, randomized, double-blind, 1-year trial. All patients were given an intramuscular injection of leuprolide acetate depot 3.75 mg every 4 weeks. Patients were assigned to one of four treatment groups: Group A received placebos for progestin and estrogen, group B received norethindrone acetate 5 mg daily and placebo for estrogen, group C received norethindrone acetate 5 mg and conjugated equine estrogens 0.625 mg daily, and group D received norethindrone acetate 5 mg and conjugated equine estrogens 1.25 mg daily. Pelvic pain scores were assessed monthly, and bone density was measured after 24 and 52 weeks.. By week 8, all four groups showed significant improvement in pelvic pain scores compared with baseline levels. A higher proportion of group D patients terminated the study prematurely due to a lack of improvement in symptoms. Group A experienced a 6.3 +/- 2.3% (P < or = .001) loss in bone density after 52 weeks of treatment, whereas bone density was preserved in all three add-back groups.. The use of leuprolide acetate depot in combination with norethindrone acetate 5 mg alone, or with norethindrone acetate and conjugated equine estrogens 0.625 mg, provides effective suppression of pelvic pain symptoms associated with endometriosis while protecting against bone loss.

Topics: Adult; Bone Density; Cohort Studies; Delayed-Action Preparations; Double-Blind Method; Drug Therapy, Combination; Endometriosis; Equilin; Estradiol; Female; Gonadotropin-Releasing Hormone; Humans; Injections, Intramuscular; Leuprolide; Lipid Metabolism; Lipids; Lumbar Vertebrae; Norethindrone; Pain Measurement; Patient Dropouts; Pelvic Pain; Progesterone Congeners; Vasomotor System

To evaluate the efficacy of gestrinone versus leuprolide acetate (LA) in improving pelvic pain in women with endometriosis and to compare their effects on bone mineral density and serum lipid profile.. Multicenter, double-blind, double-dummy, randomized clinical trial.. Six academic departments specialized in the study of endometriosis.. Fifty-five women with moderate or severe pelvic pain and laparoscopically diagnosed endometriosis.. Six-month treatment with oral gestrinone (n = 27) or IM depot LA (n = 28) followed by 6-month follow-up.. Variations in severity of dysmenorrhea, deep dyspareunia, and nonmenstrual pain as shown by a visual analog scale and a verbal rating scale, modifications in bone mineral content as shown by dual-roentgenogram absorptiometry, and variations in serum cholesterol subfractions and lipoprotein(a) concentrations.. Significant improvements were observed in all three symptoms considered in both treatment arms. Moderate or severe pain symptoms recurrence on both pain scales was observed in 2 of 17 (11.8%) patients given gestrinone compared with 9 of 17 (52.9%) of those given LA (odds ratio, 0.12; 95% confidence interval, 0.02 to 0.69). Lumbar bone mineral density increased slightly in the gestrinone group but decreased by 3% in the LA one. High-density-lipoprotein cholesterol fell by 25% and lipoprotein(a) decreased by approximately 40% in the gestrinone-treated women but did not vary in those receiving LA.. Oral gestrinone is at least as effective as depot LA for pain relief in women with symptomatic endometriosis. A tendency to prolonged pain reduction was observed after gestrinone compared with LA treatment. Gestrinone does not negatively affect bone density but variations in serum lipids need further evaluation.

Topics: Absorptiometry, Photon; Adolescent; Adult; Bone Density; Double-Blind Method; Dysmenorrhea; Endometriosis; Female; Gestrinone; Gonadotropin-Releasing Hormone; Humans; Leuprolide; Lipids; Pelvic Pain; Progesterone Congeners

To demonstrate that adenomyosis is a rare cause of dysmenorrhea or chronic pelvic pain (CPP) in the adolescent population that can be identified with magnetic resonance imaging (MRI) and to report resolution of adenomyosis by MRI after a course of hormonal suppression in 4 adolescents.. Retrospective case series of 4 adolescents with adenomyosis on pelvic MRI at Texas Children's Hospital.. Continuous oral contraceptive (COC) therapy or leuprolide acetate.. Lesions on pelvic MRI after treatment.. We reviewed medical records of 4 adolescents with CPP and adenomyosis on T2-weighted pelvic MRI. All patients had initial diagnostic pelvic MRI and then definitive hormonal intervention. Repeat imaging was obtained after a symptom-free interval.. Patient ages ranged from 12 to 16 years. One patient had resolution of symptoms with COC therapy. MRI performed 3 years later showed no adenomyosis. Three patients failed COC therapy. All were symptomatically improved after therapy with a gonadotropin-releasing hormone agonist. Follow-up MRI performed at intervals between 6 months and 3 years showed resolution of adenomyosis.. MRI can raise suspicion for the diagnosis of adenomyosis in adolescents with refractory CPP. Subsequent MRI can show regression of lesions after symptom resolution with hormonal therapy.

Topics: Adenomyosis; Adolescent; Antineoplastic Agents, Hormonal; Child; Chronic Pain; Contraceptives, Oral; Dysmenorrhea; Endometriosis; Female; Gonadotropin-Releasing Hormone; Humans; Leuprolide; Magnetic Resonance Imaging; Pelvic Pain; Retrospective Studies; Texas; Treatment Outcome

The aim of this study was to evaluate the improvement in catamenial chronic pelvic pain (CPP) after Gonadotropin Releasing Hormone analogue (GnRH-a) administration in women affected by adenomyosis or endometriosis. We retrospectively analysed clinical data of 63 premenopausal women with clinical suspect of adenomyosis (15 women, Group A) or endometriosis (48 women, Group B), which received GnRH-a in order to reduce CPP intensity during the time on surgery waiting list. Main outcome measures were variation of CPP intensity, numbers of days requiring analgesics and lost work productivity before and three months after GnRH-a administration. Compared to baseline, a significant decrease in CPP intensity (p < 0.05) was observed in both groups, even if this reduction was significantly higher in Group A than in Group B (p < 0.001). In both groups, moreover, a significant reduction in number of days requiring analgesics (p < 0.05) and lost work productivity (p < 0.05) was detected. In conclusion, GnRH-a administration in women with clinical suspect of adenomyosis induces a greater reduction in CPP when compared to women with endometriosis, thus representing a potential ex adiuvantibus criteria, helping TV-US in the clinical diagnosis of adenomyosis.

Topics: Adenomyosis; Adult; Chronic Pain; Endometriosis; Female; Humans; Leuprolide; Middle Aged; Ovarian Diseases; Pelvic Pain; Retrospective Studies; Treatment Outcome

To evaluate the efficacy and tolerability of a low-dose estrogen-only regimen as a short-term add-back therapy during post-operative GnRH agonist (GnRHa) treatment of patients with endometriosis.. Retrospective cohort study. One hundred seventeen women of reproductive age who were treated with post-operative GnRHa after conservative laparoscopic surgery for endometrioma were eligible for this study. The patients were divided into two groups: group A (n = 56) received tibolone (2.5mg) between 2002 and 2004 and group B (n = 61) received estradiol valerate (1mg) between 2005 and 2007 as an add-back therapy for five months, beginning at the time of the second injection of a GnRHa. The incidence of hypoestrogenic symptoms and the degree of pelvic pain according to a verbal rating scale (VRS) scoring system, the incidence and patterns of uterine bleeding during add-back therapy, the endometrial thickness by ultrasonography two months after the last GnRHa treatment, and the serum CA-125 level were evaluated.. The incidence of uterine bleeding, hypoestrogenic symptoms such as hot flashes and sweating, and pelvic pain did not differ significantly between the two treatment groups. However, the endometrium was thicker in group A than group B (p = 0.022). In group B, the frequency of uterine bleeding was lower from the second month after starting add-back therapy than in group A, but without statistical significance (at the sixth month, p = 0.086).. The low-dose estrogen-only regimen was efficacious and tolerable as a short-term add-back therapy during post-operative GnRHa treatment after surgery for endometriosis.

Topics: Adult; Cohort Studies; Endometriosis; Endometrium; Estradiol; Estrogens; Female; Gonadotropin-Releasing Hormone; Humans; Leuprolide; Norpregnenes; Pelvic Pain; Ultrasonography

One of the most common gynaecological causes of chronic pelvic pain is endometriosis. A lack of correlation between laparoscopic findings and pelvic pain has been reported. As endometriotic lesions are under hormonal influence, the effects of the gonadotrophin-releasing hormone (GnRH) analogues cause shrinkage of the deposits, reducing symptoms caused by them. We carried out a longitudinal, interventional pilot study, examining the effect of leuprorelin acetate 3.75 mg (Prostap SR, Wyeth) on pelvic pain prospectively. Preliminary data shows a decrease in pain scores from before to after treatment which is statistically significant (P<0.0001) as well as a general improvement in other symptoms. Laparoscopy showed that symptom intensity is not always related to severity of endometriosis and the worst symptoms may not necessarily be due to pathology. Therefore, it is beneficial to treat women with CPP with GnRH analogues as first-line management to relieve painful symptoms, avoid surgical risks and save money.

Topics: Adult; Chronic Disease; Dose-Response Relationship, Drug; Drug Administration Schedule; Endometriosis; Female; Follow-Up Studies; Humans; Injections, Subcutaneous; Laparoscopy; Leuprolide; Longitudinal Studies; Pain Measurement; Patient Satisfaction; Pelvic Pain; Periodicity; Pilot Projects; Prospective Studies; Sampling Studies; Severity of Illness Index; Treatment Outcome

Chronic, painful bladder symptoms are diagnostic and therapeutic challenges for urologists and gynecologists. The aims of this study were to evaluate women with menstrual cycle-related changes in their interstitial cystitis symptoms, to treat them with hormonal manipulation, and to follow them long term.. The cases of women who were referred to a tertiary care center with interstitial cystitis and menstrual cycle exacerbation of symptoms were evaluated in a retrospective study. Fifteen women had undergone laparoscopy that was followed immediately by cystoscopy and bladder hydrodistension. Patients were then treated with leuprolide acetate or oral contraceptive pills.. Patient age ranged from 23 to 48 years. The duration of symptoms ranged from 1 to 26 years. Ten patients (67%) had findings of both interstitial cystitis and peritoneal endometriosis. Five of 15 patients (33%) had interstitial cystitis, but no endometriosis was found. Symptoms improved for 8 of 9 women who were treated with leuprolide acetate and for 5 of 6 women who were treated with oral contraceptive pills. Patients were followed up for an average of 55 months.. Diagnostic laparoscopy should be considered together with hydrodistension of the bladder for women with pelvic pain and irritative bladder symptoms that are exacerbated premenstrually. Endometriosis is often present in patients with these complex symptoms. This is the first report of hormonal treatment for chronic, cyclic irritative bladder symptoms; improvement appears to occur even when endometriosis is not identified by laparoscopy.

Topics: Adult; Chronic Disease; Contraceptives, Oral; Cystitis, Interstitial; Cystoscopy; Dilatation; Endometriosis; Female; Follow-Up Studies; Humans; Laparoscopy; Leuprolide; Menstrual Cycle; Middle Aged; Pelvic Pain; Peritoneal Diseases; Retrospective Studies; Treatment Outcome; Water

To test the hypothesis that women with pelvic venous congestion have a reduction of reactivity of their peripheral circulation.. Comparison was made between 20 women with chronic pelvic pain due to congestion and a control group of 15 pain-free women matched for age, parity and body weight. A comparison of these results was made with those from six postmenopausal women taking hormone replacement therapy.. Study and control groups were investigated during the mid-follicular phase of the menstrual cycle (days 5-9) and the mid-luteal phase (days 19-23). The study group was also investigated during the fifth month of treatment with suppression of ovarian activity with leuprorelin or medroxyprogesterone acetate or six months after hysterectomy and bilateral salpingo-oophorectomy. Head-up tilt sufficient to increase intra-vascular pressure in the toe by a standard 40 mmHg was used as a means of raising venous pressure in the lower limb. Skin capillary red blood cell velocity (flux) was measured using a laser Doppler flow probe placed over the pulp of the big toe. Heart rate and blood pressure were also recorded. The change in skin blood flow following head-up tilt was expressed as a percentage of baseline flow in the supine position.. Percentage change in skin red blood cell flux, heart rate and blood pressure in response to 40 degrees head-up tilt.. In the control group the median response to head-up tilt in the follicular phase was one of a reduction in flux, whereas in the luteal phase it was more variable ranging from an increase to a decrease in flux. The responses in the pelvic congestion group in both the follicular and luteal phases were similar to those of the control group in the luteal phase. A small but significant increase in heart rate in response to tilt in the pelvic pain group, compared with the control group, was interpreted as being due to a fall in venous return. Treatment of the pelvic congestion group by medical suppression of ovarian activity or total hysterectomy with bilateral salpingo-oophorectomy resulted in a significant change in response to head-up tilt from the variable type of luteal response to one of a more constant reduction in flux, similar to that of the control group in the follicular phase. A reduction in flux was also found consistently in postmenopausal women.. The study confirms the hypothesis that women with pelvic pain due to congestion show a change in peripheral vascular reactivity which returns to normal after suppression of ovarian activity. It seems likely that some alteration of normal ovarian function is responsible for the observed changes in peripheral blood flow in response to a rise in venous pressure in women with pelvic congestion.

Topics: Blood Flow Velocity; Case-Control Studies; Contraceptive Agents, Female; Female; Fertility Agents, Female; Follicular Phase; Head-Down Tilt; Heart Rate; Humans; Leuprolide; Luteal Phase; Medroxyprogesterone Acetate; Pelvic Pain; Peripheral Vascular Diseases; Postmenopause; Skin

Although laparoscopy has been considered the gold standard for the diagnosis of endometriosis, it often fails to detect the disease and provide lasting pain relief. Motivated by concerns for patient well-being, treatment efficacy, and cost containment, Lovelace Health Systems of Albuquerque, New Mexico, turned to the Lovelace Chronic Pelvic Pain Protocol, based on a chronic pelvic pain algorithm used to identify potential candidates for therapy with gonadotropin-releasing hormone agonist (GnRH agonist). Since the protocol's introduction in January 1997, empiric therapy with GnRH agonist has proved beneficial to patients, physicians, and healthcare system budgets.

Topics: Algorithms; Chronic Disease; Clinical Protocols; Decision Making; Endometriosis; Female; Gonadotropin-Releasing Hormone; Health Care Costs; Humans; Hysteroscopy; Leuprolide; New Mexico; Organizational Case Studies; Pelvic Pain; Program Evaluation

Ovarian remnant syndrome is an uncommon problem that may follow bilateral oophorectomy. These patients may present with chronic pelvic pain or pelvic masses and may require surgery to confirm or exclude the diagnosis. In this report we describe the successful use of the gonadotropin releasing hormone agonist (GnRH-a) stimulation test to identify the presence of functioning ovarian tissue in three women with ovarian remnant syndrome who presented for evaluation of persistent chronic pelvic pain. In these cases the endogenous gonadotropin flare was able to stimulate the production of significant quantities of estradiol to confirm the diagnosis. The GnRH-a stimulation test may be a useful adjunct in the evaluation of women at risk for ovarian remnant syndrome prior to proceeding with surgery.

Topics: Adult; Estradiol; Female; Gonadotropin-Releasing Hormone; Humans; Leuprolide; Ovarian Diseases; Ovariectomy; Pelvic Pain; Syndrome