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Menorrhagia clinical trials

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NCT ID: NCT02519231 Completed - Menorrhagia Clinical Trials

Copper IUD Treatment Observation Study

CITROS
Start date: February 2016
Phase: Phase 4
Study type: Interventional

Studies indicate that bleeding irregularities and dysmenorrhea are common reasons for copper IUD method discontinuation. Some evidence suggests that non-steroidal anti-inflammatory medications (NSAIDs) can help improve bleeding during Cu-IUD use. However, these studies did not examine NSAID use with the TCu380A specifically, nor did they evaluate readily available NSAIDs such as over-the-counter naproxen. For this reason, the investigators propose a pilot trial in which new TCu380A users complaining of heavy or prolonged menstrual bleeding or spotting after 1 month of use are randomized to naproxen or placebo to be taken the first 7 days of menstruation for three consecutive cycles, and then observed for one cycle without treatment.

NCT ID: NCT02475356 Completed - Clinical trials for Menorrhagia, Dysmenorrhea

Prospective, Non-interventional, Multi-center Safety Study of Mirena for Heavy Menstrual Bleeding and Dysmenorrhea

J-MIRAI
Start date: August 4, 2015
Phase:
Study type: Observational

The primary objective in this study is collecting post-marketing information on the safety. Thus, it includes information under the routine clinical practice on adverse events (AEs) and adverse drug reactions (ADRs) including expulsion and abnormal bleeding that occur within the first 12 months Mirena insertion. The secondary objective(s) in this study is/are collecting information on Mirena effectiveness, such as periodic blood loss and Quality of life (QOL), use of analgesic and dysmenorrhea pain as far as these are recorded under routine clinical practice.

NCT ID: NCT02475252 Terminated - Menorrhagia Clinical Trials

Construct Validity of a Diagnostic Hysteroscopy Training Model

HSK-2
Start date: April 2015
Phase: N/A
Study type: Interventional

In a prospective case-control study, the investigators compare the Objective Structured Assessment of Technical Skills (OSATS) scores in medical students and gynecologic experts performing a hysteroscopy on a training model for diagnostic hysteroscopy. The investigators hypothesize that OSATS on a hysteroscopy training model has construct validity to discriminate between experts and novices.

NCT ID: NCT02449304 Active, not recruiting - Clinical trials for Heavy Menstrual Bleeding

Evaluation of 4th Generation Bipolar Radiofrequency Endometrial Ablation Device

Start date: March 2015
Phase: Phase 4
Study type: Interventional

All women presenting to the gynaecology outpatient clinic with heavy menstrual bleeding (HMB) in the absence of recognizable pelvic pathology, as determined by one or all of a normal pelvic ultrasound, hysteroscopy and / or endometrial biopsy, refractory to medical therapy that persists despite treatment with recommended pharmacological agents(1,2), who have no desire to preserve their fertility and are willing to have an endometrial ablation will be invited to participate. Eligible women with HMB will undergo radiofrequency G4 endometrial ablation in either an inpatient or outpatient setting according to their preference. Outcomes will be assessed by administering postal questionnaires to measure menstrual bleeding symptoms including rates of amenorrhoea, dysmenorrhoea and life quality at baseline and at 6, and 12 months after ablative treatment. After the main study, there will be an additional evaluation of the long-term effects of outpatient ablative treatments of the endometrium by postal survey at 5 years.

NCT ID: NCT02449161 Terminated - Menorrhagia Clinical Trials

The Effect of Post Ablation Medroxyprogesterone Acetate on Endometrial Amenorrhea Rates

MPA postAE
Start date: August 2015
Phase: Phase 3
Study type: Interventional

Heavy menstrual bleeding are a common reason for consultation in gynecology and are defined by International Federation of Gynecology and Obstetrics as the perception of menstrual volume increased regardless of the frequency, duration and regularity. Some studies report that up to 30% of women will suffer from heavy periods during their lifetime. The first line treatment of heavy bleeding is medical. However, a significant proportion of women require surgery. Until the 80s, hysterectomy was one of the only surgical options and often performed as the first line treatment. Since twenty years now the endometrial ablation has become a preferred option for dysfunctional uterine bleeding and avoids hysterectomy in a significant proportion of patients suffering from this type of problem. Endometrial ablation is much less invasive and morbid than hysterectomy, however, many patients do not achieve a complete amenorrhea with endometrial ablation and about 15% may have to require a new intervention, such as hysterectomy, following the persistence of menstrual problems. A Cochrane review published in 2013 showed that the satisfaction rate following endometrial ablation is high at 70-80% and about 35% of women have amenorrhea. The complete destruction of the endometrium is the most important predictor of the success of the procedure. Studies have shown that better results are obtained when the surgery is performed when the endometrium is thin or immediately following menses or following administration of a hormonal agent causes atrophy of the endometrium. One of the agents studied to prepare the endometrium before ablation is medroxyprogesterone acetate (MPA) as injectables (DMPA) and oral. Progestins have an antiproliferative effect on the endometrium. In recent years, numerous studies have examined the use of various agents preoperatively, including MPA and DMPA to facilitate surgery by reducing the thickness of the endometrium. However, few studies have focused on the conditions of the post-operative period to promote the therapeutic response to the intervention. The investigators hypothesis is whether the MPA administered in immediate post-operative would inhibit proliferation of endometrial cells responsible for the persistence of menstruation and optimize the clinical response to endometrial ablation.

NCT ID: NCT02304510 Completed - Menorrhagia Clinical Trials

Prevalence of Heavy Menstrual Bleeding in Female Population Living in Beijing

Start date: November 2014
Phase:
Study type: Observational

The purpose of the study is to estimate the prevalence of heavy menstrual bleeding (HMB) in females aged between 18 and 50 years old living in Bejing.

NCT ID: NCT02228174 Completed - Menorrhagia Clinical Trials

Sonography Guided Transcervical Ablation of Uterine Fibroids

SONATA
Start date: October 2014
Phase: N/A
Study type: Interventional

The objective of this study is to establish the safety and effectiveness of the Sonata® System in the treatment of symptomatic uterine fibroids.

NCT ID: NCT02118974 Completed - Pelvic Pain Clinical Trials

Randomized Clinical Trial Comparing Conventional Laparoscopic and Robot-Assisted Laparoscopic Hysterectomy

Start date: May 2014
Phase: N/A
Study type: Interventional

Robotic-assisted surgery is becoming more prominent within the specialty of Gynecologic surgery with little direct evidence that it is if not better than traditional laparoscopic surgery, at least equivalent. We designed a randomized-controlled trial to compare operative times, length of hospital stay, estimated blood loss, and post-operative complications associated with these two methods of minimally invasive hysterectomy.

NCT ID: NCT02087228 Terminated - Menorrhagia Clinical Trials

Evaluation of the Endometrial Cavity After Endometrial Ablation

Postablation
Start date: September 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the shape, size and appearance of the inside of the uterus six months following an endometrial ablation procedure. Half of the participants will have their ablation performed with a hydrothermal ablation device and the other half will have their ablation performed with a device that uses radiofrequency energy.

NCT ID: NCT02035332 Completed - Clinical trials for Menorrhagia Due to Benign Causes

A Two-Phase Clinical Study of the Minerva AURORA Ablation System

Start date: May 2011
Phase: N/A
Study type: Interventional

The primary objective of this study is to evaluate the use of the Aurora Ablation System in reducing menstrual blood loss at 12 months post-treatment. The occurrence of adverse events will be assessed along with an assessment of the reduction of uterine bleeding as measured by a pictorial blood loss assessment chart (PBLAC) or menstrual diary.