Treatment Trials

78 Clinical Trials for Various Conditions

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RECRUITING
Safety and Effectiveness of the KOKO Device to Treat Primary Abnormal Postpartum Uterine Bleeding or Hemorrhage
Description

The purpose of this study is to evaluate the safety and effectiveness of the KOKO™ device in the control and reduction of primary abnormal postpartum uterine bleeding or hemorrhage.

RECRUITING
IV Iron Trial for Anemia Related to Uterine Bleeding in Female Patients Presenting to the Emergency Department
Description

The primary aim of this randomized trial is to assess the efficacy of IV Ferric Derisomaltose vs Oral Iron in the management of women with severe Iron Deficiency Anemia due to Uterine Bleeding in the emergency department.

COMPLETED
A Study of Severe Uterine Bleeding Following Exposure to Direct Oral Anticoagulants
Description

The purpose of this study is assess the: (a) incidence of severe uterine bleeding (SUB) following exposure to individual direct oral anticoagulant (DOACs) (rivaroxaban, apixaban, dabigatran) and warfarin, (b) individual DOACs (rivaroxaban, apixaban, dabigatran) association with risk of SUB compared with warfarin, and (c) individual DOACs (rivaroxaban, apixaban, dabigatran) associated with risk of SUB compared with other individual DOACs - among women with prior diagnoses for DOAC and warfarin indications (non-valvular atrial fibrillation \[NVAF\], venous thromboembolism \[VTE\], total hip replacement \[THR\] or total knee replacement \[TKR\]).

RECRUITING
IV Iron vs Oral Iron for Treatment of Anemia in Women With Abnormal Uterine Bleeding
Description

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.

COMPLETED
A Study of the Efficacy and Safety of a 3-month Treatment Course of Ulipristal Acetate for the Treatment of Abnormal Uterine Bleeding Associated With Leiomyomas
Description

This study will evaluate the superiority of ulipristal acetate versus placebo for the treatment of abnormal uterine bleeding associated with uterine fibroids

COMPLETED
A Study of the Efficacy and Safety of Ulipristal Acetate Intermittent Treatment for Abnormal Uterine Bleeding Associated With Leiomyomas
Description

This study will evaluate the superiority of ulipristal acetate versus placebo for the treatment of abnormal uterine bleeding associated with uterine fibroids

UNKNOWN
Safety & Effectiveness Study of AEGEA Vapor System to Treat Excessive Uterine Bleeding
Description

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)

Conditions
COMPLETED
Decisionmaking for Abnormal Uterine Bleeding (AUB)
Description

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.

COMPLETED
Safety of FCM vs. Standard of Care in Treating Iron Deficiency Anemia in Heavy Uterine Bleeding and Post Partum Patients
Description

The Objective of this study is to study the safety of FCM in patients with anemia caused by Heavy Uterine Bleeding and the Post Partum state.

Conditions
COMPLETED
Comparison of the Safety and Efficacy of Intravenous Iron Versus Oral Iron in the Treatment of Anemia Secondary to Heavy Uterine Bleeding
Description

This study compares of the safety and efficacy of intravenous iron vs oral iron in the treatment of anemia secondary to heavy uterine bleeding

Conditions
COMPLETED
Treatment of Non-Gestational Acute Uterine Bleeding: A Randomized Trial
Description

To determine the relative efficacy of multidose medroxyprogesterone acetate (MPA, Provera) and a multidose, monophasic combination oral contraceptive in the treatment of hemodynamically stable women with non-gestational, acute uterine bleeding.

COMPLETED
Efficacy and Safety Study for the Treatment of Dysfunctional Uterine Bleeding
Description

The purpose of this study is to determine whether the study drug is safe and effective in the treatment of dysfunctional uterine bleeding.

Conditions
RECRUITING
Combined Ketorolac and Lidocaine Paracervical Block for Office Hysteroscopy
Description

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.

TERMINATED
Pain Reduction and Ovarian Perfusion Following Uterine Fibroid Embolization
Description

The goal of this study is to assess of Pressure-Enabled Drug Delivery on fibroid treatment in patients undergoing UFE.

TERMINATED
Role of Blood Management in Perioperative Outcomes
Description

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.

COMPLETED
Outcomes on Abdominal Versus Vaginal Morcellation At Time of Hysterectomy
Description

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.

COMPLETED
Patient Satisfaction With Initial Phone Call Versus Office Visit Following Minimally Invasive Hysterectomy, a Randomized Controlled Trial.
Description

Patients will be randomized to clinic or telephone follow up after outpatient TLH. surveys will document patient satisfaction.

UNKNOWN
Stopping Heavy Periods Project
Description

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.

COMPLETED
What Are we Missing? Diagnosing Uterine Adenomyosis Using Ultrasound Elastography
Description

To improve the clinical care of women with pelvic pain and abnormal uterine bleeding due to benign uterine conditions including leiomyomas (uterine fibroids) and adenomyosis by evaluating the accuracy of radiology diagnostic exams (MRI(magnetic resonance imaging), ultrasound and ultrasound with elastography).

COMPLETED
Does Concomitant Use of Combined Oral Hormonal Steroids Stop Bleeding in Women Using Etonogestrel Implants (Implanon/Nexplanon®)?: A Randomized Controlled Study
Description

The specific aims are to determine if more women using Etonogestrel (ENG) contraceptive implants who report a bleeding-spotting episode of at least seven days will stop bleeding within 3 days of beginning a 14-day course of combined oral hormonal steroids, as compared to women receiving 14 days of placebo.

TERMINATED
Treatment of Unacceptable Bleeding Patterns in ETG Implant Users With an Oral Contraceptive
Description

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

TERMINATED
Study of a Progestin to Prevent Bleeding Associated With Initiation of Medical Menopause With GnRH Agonist
Description

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

UNKNOWN
Estradiol vs Lysteda in Treatment of Heavy Menstrual Bleeding
Description

Treatment with Estradiol is non-inferior to treatment with Tranexamic acid in reducing the amount and duration of menstrual blood loss in women with cyclic heavy menstrual bleeding

TERMINATED
Belfort Dildy- Obstetrical Tamponade System Post-Marketing Surveillance Program
Description

This is an open, post-marketing surveillance study obtaining data retrospectively on 300 women, of any age, treated with the BD-OTS for postpartum uterine bleeding.

COMPLETED
DMPA & High Dose Oral Progestin (MPA) Tablets in Outpatient Treatment of Acute Excessive Vaginal Bleeding
Description

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

COMPLETED
ThermaChoice III Under Local Sedation in the Office Setting
Description

Investigational study to determine if an endometrial ablation for heavy uterine bleeding, can be tolerated in the office setting without the use of intravenous medication.

RECRUITING
DAISY Uterine Drain Device Evaluation
Description

The goal of this study is to obtain user feedback while placing and observing the DAISY uterine drain with wall suction. This study defines the obstetrical surgeons as "users" and the patients in whom the drain is placed as "participants." Participants are pregnant women who are undergoing cesarean delivery (CD) or D \& C, who have not entered active labor, who have consented to drain placement and who have met all the inclusion/exclusion criteria. Users are staff or fellow obstetrical surgeons who will use the drain and provide the evaluation.

COMPLETED
Suction Cervical Stabilizer Compared to Standard Tenaculum for Intrauterine Procedures
Description

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.

RECRUITING
A Registry to Gather Real World Use Data on the Cerene® Cryotherapy Device
Description

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.

COMPLETED
Alternate Day Versus Daily Oral Iron Therapy in Adolescents
Description

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.