41 Clinical Trials for Various Conditions
The purpose of this study is to determine whether the study drug is safe and effective in the treatment of dysfunctional uterine bleeding.
Metrorrhagia
This study investigates whether intravenous (IV) iron \[Feraheme (ferumoxytol) injection)\] is a better treatment than oral iron pills (ferrous sulfate) for correcting anemia in women who have heavy menstrual bleeding and anemia. Investigators will study whether women's blood counts respond better, respond more quickly, and if women prefer the IV treatment or the oral treatment. Women who have heavy menstrual bleeding and anemia will be randomly assigned to receive treatment with either oral iron pills or IV iron infusions. Investigators will then check whether and how quickly the anemia improves, and survey participants on how satisfied they were with the treatment.
Anemia, Iron Deficiency, Heavy Menstrual Bleeding
This study will evaluate the superiority of ulipristal acetate versus placebo for the treatment of abnormal uterine bleeding associated with uterine fibroids
Leiomyoma, Uterine Hemorrhage
This study will evaluate the superiority of ulipristal acetate versus placebo for the treatment of abnormal uterine bleeding associated with uterine fibroids
Leiomyoma, Uterine Hemorrhage
The purpose of this study is to determine if using a computer survey about preferences for treatment of abnormal uterine bleeding (AUB) is useful and if it will improve patient satisfaction with clinical care and decision making. This study is a two-part study. The first pilot tests the computerized tool to ensure it is understood by patients, then the second part is a randomized study (computerized tool versus usual care) to see if improvements are made in satisfaction and if there are reductions in decision regret.
Abnormal Uterine Bleeding
The purpose of this research study is to evaluate the best way to manage breakthrough spotting and bleeding during an extended use regimen of NuvaRing®. Ease of use and acceptability of a flexible regimen of NuvaRing® will also be evaluated. A comparison of cyclic mood symptoms, pelvic pain, and headaches will be made between a standard 21/7 regimen and an extended regimen.
Breakthrough Bleeding, Breakthrough Spotting
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.
Endometrial Bleeding, Periodontal Disease
In this study, the investigators would like to see if giving medroxyprogesterone acetate for 3 weeks after Leuprolide acetate injection will help to decrease this amount of bleeding, decrease the amount of nausea, bloating and cramping and increase patient satisfaction
Dysfunctional Uterine Bleeding
The purpose of this study is to investigate the effectiveness and acceptability of high dose MPA (20mg oral 3 times a day) for 3 days combined with an injection of DMPA 150 mg intramuscularly in the treatment of acute heavy, prolonged uterine bleeding who have been identified as being eligible for outpatient management
Dysfunctional Uterine Bleeding
A randomized double-blind placebo controlled trial comparing the effect of a combined ketorolac and lidocaine paracervical block with a standard lidocaine paracervical block on procedure related pain with office hysteroscopies.
Abnormal Uterine Bleeding, Analgesia, Paracervical Block
There is currently limited information regarding the role of blood management in the benign gynecologic population and specifically, in patients who are scheduled to undergo surgery for fibroids and/or abnormal uterine bleeding. A thorough search through PubMed and clinicaltrials.gov did not reveal any studies on this issue. In 2019 at CCF only 2% of gyn patients at Main Campus were referred to blood management, but 12.6% of the main campus gyn population had a Hb of \<10.0 g/dL. The overall goal of this study is to evaluate the role of preoperative blood management in optimizing surgical outcomes by reducing the co-morbidities associated with postoperative blood transfusion.
Abnormal Uterine Bleeding
The purpose of the study is to investigate differences in perioperative and postoperative outcomes between the abdominal (AM) versus vaginal (VM) routes of contained morcellation in participants undergoing laparoscopic total hysterectomies in a randomized controlled trial.
Abnormal Uterine Bleeding, Uterine Bleeding, Fibroid Uterus, Surgery
Patients will be randomized to clinic or telephone follow up after outpatient TLH. surveys will document patient satisfaction.
Abnormal Uterine Bleeding
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.
Abnormal Uterine Bleeding, Abnormal Uterine Bleeding, Ovulatory Dysfunction, Abnormal Uterine Bleeding, Endometrial Hemostatic Dysfunction
This double-blinded, placebo-controlled, randomized trial will compare the effects of the use of a combined oral contraceptive pill to a placebo pill for women who are experiencing irregular and/or heavy bleeding associated with the use of an etonogestrel (ETG) implant. The hypothesis of the study is: * Use of combined oral contraceptive will significantly improve bleeding patterns for users of ETG implant * Continuation rate of ETG implant users will be increased by use of combined oral contraceptive in women desiring ETG implant removal because of the undesirable bleeding * Adverse events will be uncommon and acceptable to women who use a combined oral contraceptive with the ETG implant
Abnormal Uterine Bleeding, Unspecified, Uterine Bleeding Heavy
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.
Breakthrough Bleeding
Many women choose Depo-Provera for birth control because it is easy to use and very effective. However, a significant number of Depo-Provera users experience irregular bleeding during the first 90 days. Many users discontinue after their first injection due to irregular bleeding. This study will evaluate the effect of using an estrogen vaginal ring during the first 90 days of Depo-Provera use to see if it is acceptable to women and whether it decreases irregular bleeding during the first 90 days of use and increases continuation to a second injection.
Metrorrhagia
This is a 4-arm study to evaluate and compare bleeding patterns between three different doses of DR-1031 oral contraceptive with Seasonale oral contraceptive. Study participants will receive physical and gynecological exams, including Pap smear. During the study, all participants will be required to complete a diary
Breakthrough Bleeding
While there may be a decrease in the total number of bleeding days women experience with continuous-dosed COCs (no menstrual withdrawal week), these regimens frequently result in an increased number of "breakthrough" or non-scheduled bleeding days. Breakthrough bleeding is among the main reasons cited for discontinuation of combined COCs dosed traditionally (3 weeks of active pill, 1 week of placebo) or continuously, and may offset the perceived benefit of fewer withdrawal bleeding events for many women taking continuous-dosed COCs. The exact mechanisms responsible for breakthrough bleeding patterns during hormonal contraception are unknown and may be related to the pill formulation. This study is to determine whether progestin type or estrogen dose influences bleeding patterns, side effects, or satisfaction with combined oral contraceptives (COC) dosed continuously.
Breakthrough Bleeding
In this project, the proposition is that the use of daily dosed Myfembree ( a combination of relugolix with estradiol and norethindrone acetate), FDA-approved medication to treat heavy menses fibroid-related symptoms, has the potential to delay the recurrence of fibroid symptoms, prolong the improved quality of life and delay the need for re-intervention after uterine sparing surgery versus the routine standard of care.
Metrorrhagia, Pelvic Pain, Menorrhagia, Leiomyoma
VA community-based outpatient clinics (CBOCs) typically serve only a small number of women Veterans, and generally do not have the women's health care resources that are available in larger settings. Women Veterans using these sites for primary care must sometimes travel to other sites to receive women's health care. That can create travel burdens, reduce continuity of care, and negatively affect patient outcomes. To address this, VA is implementing a clinical operations innovation that supports women's primary care providers with a technology-based intervention that combines interactive communication with women's health specialists and ongoing education. This research study is evaluating the implementation and effects of this women's healthcare delivery innovation. Findings from this research will inform VA women's health clinical practice and education, and will advance science in delivering technology-supported non-face-to-face care that is applicable to other clinical conditions and patient populations.
Metrorrhagia, Urinary Incontinence, Remote Consultation, Videoconferencing, Women's Health, Menopause
The purpose of the proposed pilot study is to investigate the effectiveness, cost, safety, and long-term impact on quality of life of laparoscopic hysterectomy (LH) in relation to abdominal hysterectomy (AH) for the treatment of benign gynecologic disease in women through a randomized surgical trial.
Metrorrhagia, Menorrhagia, Leiomyoma, Adenomyosis, Pelvic Pain, Endometriosis, Pelvic Inflammatory Disease
Approximately 600,000 women undergo hysterectomy each year in the United States, of which 12% are laparoscopic. The most common indications for hysterectomy are: symptomatic uterine leiomyomas (40.7%), endometriosis (17.7%), and prolapse (14.5%). The first total laparoscopic hysterectomy was performed by Reich et al in 1988. Many studies have proven that laparoscopic hysterectomy is associated with lower preoperative morbidity, shorter hospital stay, and shorter recovery times than abdominal hysterectomy. The literature has also shown the complication rates for laparoscopic cases are similar to open procedures in the hands of an experienced laparoscopic surgeon. The American Congress of Obstetricians and Gynecologists Committee on Gynecologic Practice state that laparoscopic hysterectomy is an alternative to abdominal hysterectomy for those patients in whom vaginal hysterectomy is not indicated or feasible. The ACOG Committee on Gynecologic Practice site multiple advantages of laparoscopic hysterectomy to abdominal hysterectomy including faster recovery, shorter hospital stay, less blood loss, and fewer abdominal wall/wound infections. Despite the recommendations of ACOG for a more minimally invasive approach, 66% of all hysterectomies are performed abdominally. Key reasons for the lag in utilization of laparoscopic techniques are the technical obstacles of performing minimally invasive hysterectomies. Robotic technology has emerged as a means to decrease the learning curve and increase the availability of minimally invasive surgery to patients. A current review of the literature reveals no randomized trials evaluating the efficacy of conventional laparoscopic hysterectomy vs. robot-assisted laparoscopic hysterectomy. The investigator's aim is to address this void. The primary objective of this study is to determine whether Robot-Assisted Laparoscopic Hysterectomy is equivalent to Conventional Laparoscopic Hysterectomy with respect to operative time, blood loss, and hospital stay. The investigator's secondary objective was to assess the cost, morbidity, and mortality of each procedure.
Menorrhagia, Dysfunctional Uterine Bleeding, Leiomyoma, Pelvic Pain, Endometriosis
To evaluate patient-reported pain, bleeding, and device efficiency along with provider satisfaction and ease of use between intrauterine procedures employing a suction cervical stabilizer (new device, FDA approved, atraumatic) or single-tooth tenaculum (standard, traumatic). This device, cleared by the FDA in 2023, was studied in Europe and showed pain reduced by up to 73% and bleeding reduced by 78% compared to the single-tooth tenaculum for intrauterine contraceptive device insertion. The investigators seek to study this device in the United States, and trial it among all intrauterine procedures.
Intrauterine Device (IUD), Abnormal Uterine Bleeding
Channel Medsystems, Inc., the manufacturer of the Cerene® Cryotherapy Device (Cerene), is initiating a prospective, observational registry, the Progress registry, to gather data during real world utilization of the Cerene® Cryotherapy Device (Cerene). The primary objective of this registry is to bridge the gap between clinical results and outcomes achieved and reported during the pivotal study of Cerene and those obtained during its real-world use.
Heavy Menstrual Bleeding, Abnormal Uterine Bleeding, Menorrhagia
Iron deficiency anemia affects over half of girls and young women with heavy periods and is the most common cause of anemia worldwide. Most girls with heavy periods who also have iron deficiency anemia are prescribed iron to take by mouth every day by their doctor. There are some studies showing that taking iron every other day may actually help the iron be absorbed into the bloodstream better. This study is trying to compare how taking iron every other day compares to taking iron daily for treatment of anemia. The goal of this clinical research study is to learn which of the two methods of care will be the best way for girls and young women with iron deficiency anemia to take iron supplementation.
Iron Deficiency Anemia, Heavy Menstrual Bleeding, Abnormal Uterine Bleeding
Effects of norethindrone acetate (NTA) in patients with Nexplanon.
Birth Control, Contraception, Implant, Breakthrough Bleeding, Uterine Bleeding
This is a Double-blinded randomized placebo-controlled trial based at Eastern Virginia Medical School. Subjects who are identified in clinic having menorrhagia or abnormal Uterine bleeding (AUB) due to uterine fibroids and meet inclusion criteria based on the ultrasound (US) or Magnetic Resonance Imaging (MRI), aged 18-45 undergoing laparoscopic or Robotic assisted myomectomies. A total of 50 women in each arm of the study with symptomatic fibroids. Patients will be randomized to receive a single IV bolus injection of TXA 30mg/kg in 50ml of normal saline (intervention group) versus an IV bolus injection of normal saline of equivalent volume (placebo group) 15 minutes prior to initial surgical incision.
Fibroid Uterus, Abnormal Uterine Bleeding, Myoma;Uterus
The objective aim is to evaluate whether the use of 3D laparoscopy facilitates the vaginal cuff closure of the vaginal cuff during a total laparoscopic hysterectomy among novice laparoscopists (PGY 2-4, Fellow). This is a randomized single blinded controlled trial comparing the difference in 2D vs. 3D in regards to vaginal cuff closure time stratified by residents and fellows. Patients will undergo a total laparoscopic hysterectomy and will be randomized to either 2D versus 3D.
Uterine Fibroids, Abnormal Uterine Bleeding, Pelvic Pain, Adenomyosis
The investigators plan to study the effects of curcumin, the active ingredient in the spice turmeric, on the irregular bleeding experienced by women who use the contraceptive implant.
Bleeding, Implants, Breakthrough Bleeding