Zentralblatt für Gynäkologie
-
Randomized Controlled Trial Comparative Study Clinical Trial
[Gameprost, sulproston and dinoproston for induced abortion in the 15th-24th week of pregnancy].
In a randomized, prospective study at the Dept. of Obstetrics and Gynecology of the University Hospital of Giessen 4 different ways of inducing abortions with prostaglandins were tested between the 15th and 24th week of gestation. The aim of the study was to determine the best approach to inducing abortion in order to minimize the psychological and physical stress to the patient. Subjects randomized to the first two groups got a single cervical installation of either 0.5 mg Dinoprostongel (Prepidil, N = 22) or 0.5 mg Sulprostongel (Nalador, N = 21). ⋯ We conclude that repetitive application of Gemeprost vaginal suppositories decreases the time to abortion and subject discomfort tremendously. The application of Gemeprost suppositories provides the easiest and most efficient therapeutic approach for both patients and staff. Furthermore the regiment that provided the best results was also the most cost-effective (range 180,-DM to 317,- DM per case).
-
Multicenter Study Clinical Trial
[Primary endocrine therapy as pre- and perimenopausal metastatic breast carcinoma with leuprorelin acetate depot. German Leuprorelin Study Group].
In an open, prospective, multicentre phase III clinical trial 73 patients with newly diagnosed, metastatic breast cancer were enrolled. Most of them were hormone-receptor-positive. All patients were pre- or perimenopausal and treated with monthly sc. injections of 3.75 mg leuprorelinacetate-depot as monotherapy until disease progression. 50/73 patients (68.5%) had low-risk metastatic disease. ⋯ Treatment was well tolerated leading in only one case to a premature withdrawal due to side effects. Leuprorelinacetate-depot is a safe and effective palliative drug for pre- and perimenopausal metastatic breast cancer patients. Like other GnRH-agonists which have been evaluated for this indication, leuprorelinacetate-depot can be used as first-line endocrine treatment in these patients.
-
Multicenter Study Clinical Trial
[Treatment of uterine leiomyoma with depot leuprorelin acetate (Enantone-Gyn monthly depot). Effect on leiomyoma volume and operability. German Leuprorelin Study Group].
In an open, non-comparative clinical phase IV multicentre study the efficacy and safety of the GnRH agonist leuprorelin acetate depot (LAD) for patients with at least one symptomatic uterine leiomyoma was assessed. 144 premenopausal patients were enrolled and treated with up to six injections of 3.75 mg LAD/month subcutaneously prior to surgical intervention, e.g. either hysterectomy or myoma enucleation. Due to a profound suppression of serum-estradiol levels to castration range (< or = 30 pg/ml) an average volume reduction of all myomas from 86.6 +/- 101.3 ml to 38.5 +/- 63.5 ml became obvious for 90% of all patients. In parallel a significant shrinkage of uterine volume was observed. ⋯ Treatment was generally well tolerated. Most of the observed side effects were related to hypoestrogenism. The results of this study have shown that medical pretreatment for patients with uterine fibroids with LAD prior to surgical intervention is an effective measure to improve operability and could lead for several patients to minimal invasive surgery.
-
Review Randomized Controlled Trial Clinical Trial
[Recurrent and 2nd line therapy in ovarian carcinoma: an overview of conventional systemic therapy modalities].
Remarkable improvements in primary surgery and chemotherapy for advanced ovarian cancer have been achieved in the last decades. Nevertheless, the majority of patients still develop recurrent disease and ultimately die from ovarian cancer. Evaluation of efficient second-line treatment is of clinical relevance. ⋯ Therefore, recommendations remain inconclusive. Retrospective comparisons may help the clinician to chose the currently best available treatment for an individual patient, however, these treatments have to be evaluated in prospectively randomised trials. The protocols of the ongoing studies in refractory or recurrent ovarian cancer of the AGO Ovarian Cancer Study Group are outlined.