Efficacy and Safety Study for the Treatment of Dysfunctional Uterine Bleeding
MetrorrhagiaThe purpose of this study is to determine whether the study drug is safe and effective in the treatment of dysfunctional uterine bleeding.
Treatment of Uterine Fibroids With Asoprisnil(J867)
LeiomyomaMenorrhagia1 moreThe objective of this study is to determine the safety and effectiveness of asoprisnil in symptomatic women with abnormal uterine bleeding associated with uterine fibroids.
Endometrial Ablation With Non-hysteroscopic Methods
Dysfunctional Uterine BleedingEndometrial ablation in women with dysfunctional uterine bleeding using second generation ablation devices is a common widespread therapeutic approach. This study aims to prove that amenorrhoea rates using Novasure are higher than those observed in microwave endometrial ablation, one year following intervention.
Acceptability and Tolerance of Hysteroscopy and Hysterosonography in Consultation
MetrorrhagiaMenorrhagia is frequent and occur in 11 to 13 % of the general population. It accounts for 20% of the gynecological consultations and tends to increase with age. It can be the first symptom of a mild uterine disease or cancer (cervical or endometrial), especially if the patient is older. The most common causes are polyps, adenomyosis, fibroids, hyperplasia and cancer. Menorrhagia needs to be investigated -especially after menopause, when the prevalence of endometrial cancer is higher (10-15%). For premenopausal metrorrhagia, the assessment will be made if a pathology is suspected or if there is no response to the medical treatment within 3 to 6 months. The medical check-up consists in the first instance in a questionnaire, a clinical examination and an endovaginal ultrasound examination. If the endometrium is thickened, a focal pathology is suspected, or if the bleeding persists despite a normal endovaginal ultrasound result, further examinations including a possible biopsy are required. While hysteroscopy is widely accepted as a standard examination for uterine cavity exploration, a meta-analysis showed that the diagnostic performance of hysterosonography was equivalent. Both are carried out on an outpatient basis during a gynecological consultation and require no special preparation. Several studies seem to show that hysterosonography is less painful, causes less discomfort and is therefore more accepted by patients than hysteroscopy. This is why many practitioners continue to prefer it to hysteroscopy and associate it with the Pipelle of Cornier for the assessment of postmenopausal metrorrhagia. However, if endometrial cancer is confirmed, the histological type detected within the biopsy is the main predictor of the severity of the disease and the treatment to be given. It is therefore essential to have an accurate biopsy sampling prior to therapeutic management. It is not the case with blind biopsies (without visual control). Indeed, some studies showed that the concordance between the optical aspect of the endometrium under hysteroscopy and the histological result was close to 90%, validating the hypothesis of an improved sensitivity through visual control. The American College of Obstetricians and Gynecologists (ACOG) currently recommends an endovaginal ultrasound assessment followed by an endometrial biopsy in the event of a thickened endometrium or when a pathology is suspected. A biopsy can even be taken during the consultation, at the onset of the complaints. The last recommendations of December 2010 leave the choice to clinicians regarding the histological diagnostic modalities (a blind biopsy with the Pipelle of Cornier or a targeted biopsy under hysteroscopy), although the biopsies under hysteroscopy are recommended since 2015. However, despite its poor sensitivity, the most widely used technique in the world is the blind biopsy by aspiration performed after vaginal ultrasound or hysterosonography because it is an easy low cost method. The development of hysteroscopes with a smaller diameter and the introduction of the vaginoscopy have considerably increased the tolerance of this examination. In addition, hysteroscopy allows a simultaneous therapeutic intervention for certain indications, which is comfortable and well accepted by the patients. Unfortunately, there are few studies comparing the tolerance of the two examinations performed according to the current recommendations of good practice of hysteroscopy. Only one comparative randomized study in 2008 showed that saline infusion sonography (SIS) was less painful than hysteroscopy with vaginoscopy. However, direct comparison was impossible since women only had one of the two examinations. The Brugmann University Hospital set up a consultation called "one stop bleeding clinic" in which the two examinations are performed for each patient with abnormal bleedings, in order to increase diagnostic performance. All included patients will thus undergo a saline infusion sonography (SIS) and a hysteroscopy (HSC). Each procedure will be evaluated on pain level (EVA scale) and tolerance by the patient.
Tamoxifen to Reduce Unscheduled Bleeding in New Users of the Levonorgestrel-releasing Intrauterine...
MenorrhagiaMetrorrhagia1 moreThis study evaluates the ability of tamoxifen to improve frequent or prolonged bleeding in new users of the 52mg levonorgestrel-releasing intrauterine device (IUD). Half of participants will receive a course of tamoxifen three weeks after insertion of the IUD, while the other half of participants will receive a course of placebo.
Pilot Study of Femring Estrogen Supplementation During Depo-Provera Initiation
MetrorrhagiaMany 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.
Continuous Oral Contraceptives (COCs): Are Bleeding Patterns Dependent on the Hormones Given?
Breakthrough BleedingWhile 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.
Clinical Trial With Combination of Dienogest/Ethytnilestradiol and Drosperidona/Ethyniestradiol...
MetrorrhagiaThis trial will study the percentage of women with at least one occurrence of intracyclic bleeding (bleeding and/or spotting) during the cycles 2 and 3 of treatment with test or reference drug.
COMPARISON OF A NEW FORMULATION OF GOSERELIN (Pepti 3.6 mg) to Zoladex® 3.6 mg
Dysfunctional Uterine BleedingThe comparator drug (Zoladex 3.6 mg) is approved for use as a thinning agent for the endometrium prior to endometrial ablation. The dosing recommendation is one or two depots with each depot given four weeks apart. When two depots are administered, surgery should be performed within two to four weeks following administration of the second depot.
Surgical Success After Laparoscopic vs Abdominal Hysterectomy
MetrorrhagiaMenorrhagia5 moreThe 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.