15 Clinical Trials for Various Conditions
Irregular or prolonged menstrual bleeding and/or spotting are common side effects in patients using progestin-only hormonal contraception such as levonorgestrel implants (Norplant). Doxycycline, a drug approved by the Food and Drug Administration (FDA) to treat gum disease, may reduce the occurrence of uterine bleeding and spotting in women who use Norplant. This study will evaluate the effects of doxycycline on uterine bleeding/spotting in women using Norplant.
This study is a randomized clinical trial comparing the effectiveness of the levonorgestrel intrauterine system (LNG-IUS) to combined oral contraceptives (COCs) for improving quality of life among women who report heavy menstrual bleeding.
The purpose of this study is to to determine pharmacodynamic effects of a vaginal ring delivering either 1,500 or 2,500 μg of CDB-2914 per day during 6 months of treatment on: 1. follicular function and inhibition of ovulation 2. the endometrium 3. bleeding patterns; and also to assess safety including effects on the endometrium
The purpose of this study is to determine the safety and efficacy of a continuous combined oral contraceptive pill (CCOCP) regimen. The investigators hypothesize that there will be a decrease in the number of vaginal bleeding days in the continuous regimen compared to a traditional 21/7 regimen. In addition, the investigators hypothesize that there will be increased endometrial and ovarian suppression in the CCOCP regimen.
This study evaluates if AI can be used with transvaginal ultrasound images for early detection of endometrial cancer or premalignant lesions.
The EASE Clinical Trial is prospective, multi-center, single-arm (open-label), non-randomized, clinical trial to evaluate the Minitouch Endometrial Ablation System ("Minitouch System") in premenopausal women with menorrhagia.
The purpose of the study is to evaluate the safety and effectiveness of the Cerene Cryotherapy Device in reducing menstrual bleeding in women with heavy menstrual bleeding (menorrhagia) due to benign causes for whom child bearing is complete.
This study will look at the optimal order in which to perform concurrent office hysteroscopy and endometrial biopsy in female patients who present for evaluation of abnormal uterine bleeding at a fibroid and endometriosis treatment center.
The purpose of this study is to determine if the AEGEA Vapor System for endometrial ablation is safe and effective for reducing menstrual blood loss in women with excessive uterine bleeding (menorrhagia)
The purpose of this study is to compare the effects (good and bad) of subantimicrobial dose doxycycline on the irregular bleeding women experience when taking continuous oral contraceptive pills. This research is being done because currently, there is no effective treatment for this condition. Findings from this study could help to decrease the side effects of birth control pills and decrease unplanned pregnancies.
Excessive menstrual loss (menorrhagia) is a common condition that affects women of reproductive age, and can result in anemia, chronic fatigue and lost wages from work. The traditional first line management involves treatment with oral contraceptives or non-steroidal anti-inflammatory agents. Many women ultimately undergo hysterectomy, a major operative procedure associated with increased costs, loss of feeling of womanhood, debilitating complications and on rare occasions, death. The newer global endometrial ablation (GEA) devices allow the destruction of the endometrial lining, without the removal of the uterus, in an ambulatory surgery setting. GEA offers a safe and effective alternative to hysterectomy with minimal risks and without unpleasant side-effects. Presently, global endometrial ablation is offered as an alternative to hysterectomy, after medical intervention has failed. This study will determine the role of global endometrial ablation in the initial management of menorrhagia. Women seeking treatment for menorrhagia will be randomized to either the medical treatment arm or the global endometrial ablation arm. This study will be the first to compare clinical efficacy and costs between oral contraceptive pills and global endometrial ablation in the initial management of menorrhagia and could potentially change the management of menorrhagia and impact millions of women who suffer from this condition.
This study, conducted jointly by the National Cancer Institute and the Kaiser Permanente Center for Health Research Northwest (KPCHRN) in Portland, Oregon, will lay the groundwork for a future study to identify precursors of endometrial cancer; that is, conditions that precede development of cancer of the lining of the uterus. The diagnosis of endometrial hyperplasia (a condition of abnormal proliferation of endometrial tissue) includes most precursors of endometrial cancer, as well as many benign conditions. Currently, three methods of classifying endometrial cancer precursors have been suggested based on endometrial hyperplasia findings, but it is not known which classification best predicts cancer risk. This study will examine surgical specimens of hyperplasia and cancer from women diagnosed with endometrial cancer at least 2 years after a diagnosis of endometrial hyperplasia. Investigators will estimate the percentage of cases with different degrees of hyperplasia, and assess the subsequent cancers that developed. This will allow them to rank hyperplasia lesions according to cancer risk and identify lesions that represent the most immediate cancer precursors. They will also review patients medical charts for information related to cancer risk and treatment. Study participants will include women enrolled in the KPCHRN who are 40 years of age or older and who were diagnosed with endometrial cancer at least 2 years after being diagnosed with endometrial hyperplasia.
The Her Option® Cryoablation Therapy System is a closed-loop cryosurgical device that is used to ablate the endometrial lining in pre-menopausal women with menorrhagia (excessive menstrual bleeding) due to benign causes. This is a non-incisional procedure, which can be performed in a physicians office with minimal sedation. Initial FDA clinical studies were conducted with a two-freeze treatment pattern consisting of a 4 minute freeze with the Cryoprobe positioned in one cornu followed by a second freeze of 6 minutes with the Cryoprobe repositioned in the contralateral cornu. Since completion of the early studies, many physicians have experimented with varying freeze patterns using longer freeze durations and/or additional freezes at the fundus and the lower uterine segment. The results, as reported in the literature, indicate that these extended freeze patterns produce significantly better results than the original regimen.
This is an observational, exploratory study designed to collect (record) and analyze normal and abnormal sound data from the human bladder during surgery using a novel sensor-based catheter system (Electronic Catheter Stethoscope) and to develop algorithms to detect changes of baseline bladder and ureteral function. The Electronic Catheter Stethoscope device will measure acoustic and pressure data within the bladder. The measurements will be used to detect any leakage from the bladder and/or changes in baseline ureteral flow by correlation of sound data with surgical data reported by the surgeon. These data will be used to develop algorithms to detect changes of baseline bladder and ureteral function. The algorithms will be tested in future clinical trials.
This study involves evaluating a procedure in which the study device, the HALO90 Ablation catheter, is used to heat a thin layer of tissue lining the rectum using radiofrequency (RF) energy in subjects suffering from radiation proctitis (acute inflammation of the inner lining of the rectum caused by the side effects of radiation treatments that can lead to bleeding). In medical procedures, the RF energy used with this device, has been historically used in shrinking or removing soft-tissue, for surgical cutting, and for stopping bleeding. The device is cleared by the Food and Drug Administration (FDA) for use in coagulation (to assit with stoping bleeding and clotting of blood) of tissue within the digestive tract. The device has been used in areas outside the esophagus (inner lining of the throat), including the rectum to treat radiation proctitis. The stoppage of bleeding of radiation proctitis, using the HALO device, may be one method to control the bleeding. The purpose of this study is to evaluate the effectiveness and record the results of treatment of radiation proctitis using the HALO device.