Active clinical trials for "Menorrhagia"

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.

To compare the efficacy of tranexamic acid and diosmin in reducing menstrual blood loss in women having Intra Uterine Contraceptive Device (IUD) and suffer from menorrhagia.

Uterine Fibroids (UF) are noncancerous (benign) tumors that commonly occur in up to 80% of women of reproductive age. Symptoms can include heavy menstrual bleeding (HMB), low back pain, urinary frequency and urgency, gastrointestinal symptoms, and fatigue. In participants with UF, this study will prospectively assess changes in patient-reported quality of life and patient-reported effectiveness in controlling HMB when treated with elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules (elagolix + E2/NETA). Around 200 adult premenopausal female participants in the United States with a diagnosis of HMB associated with UF and are prescribed elagolix + E2/NETA by their physicians as per standard of care will be enrolled in this direct-to-patient observational study for up to 6 months. Participants will have been prescribed elagolix + E2/NETA within the last 30 days prior to enrollment and will continue to take elagolix + E2/NETA throughout study participation. There may be a higher burden for participants in this study compared to standard of care. Electronic patient reported outcomes (ePROs) will be collected at baseline, 1, 3 and 6 months to assess the impact of Elagolix + E2/NETA on patient-reported quality of life.

A randomized, placebo controlled, parallel group, double blind study to compare the 3-month adherence and efficacy of Active Iron in subjects with or at-risk of iron deficiency and a history of intolerance to oral iron. Subjects with intolerance and treatment failure due to oral iron (male and female subjects, aged 18 to 55 years, with mild to moderate iron deficiency, with or without anaemia) are eligible. Sixty subjects are randomised into three groups (14 mg elemental iron, 25mg elemental iron and 50mg elemental iron daily). The primary objective is to assess adherence/persistence (including using pill counts). Secondary objectives are to assess gastrointestinal tolerability, haematological efficacy and health related quality of life.

The objective of this study is to evaluate the safety and effectiveness of the endometrial ablation device Librata in reducing menstrual blood loss at 12 months post-treatment when used in pre-menopausal women with menorrhagia due to benign causes for whom childbearing is complete.

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.

A prospective, single-arm, non-randomised study to evaluate the Librata device performance and acute safety in performing global endometrial ablation in pre-menopausal women with heavy menstrual bleeding.

Objectives: To assess if the administration of ulipristal acetate (UPA) in users of the levonorgestrel-releasing intrauterine system (LNG-IUS) with breakdown bleeding or abnormal bleeding, could be able to inhibit the bleeding and if this effect will be sustainable up to three months after treatment. Material and methods: A total of 32 women aged between 18-45 years, users of the LNG-IUS with breakdown bleeding, abnormal bleeding or prolonged bleeding (bleeding more than 14 days) or episodes of bleeding with intervals less than 24 days). The study is an experimental, double blind randomized (16 women will receive UPA 5 mg/day/5 days; 16 women will receive placebo/1 time/day/5 day). The women will invited to participated at the Family Planning clinic at the day they consulted with the complaint of bleeding. That day they will allocated at random to UPA or placebo group. They will oriented to fill out a bleeding calendar through 90 days after the pill intake. In addition a ultrasonography scan will be perform before the first day of pill intake and at 90 days after. Statistical analysis: A a pilot study the sample was estimated in 26 women (13 at each group) based at the estimative of success of 0.95 with UPA and 0.35 with placebo with significance of 0.05 and power of 80%. The sociodemographic characteristics will be analyzed as mean and SD and will compared through Mann-Whitney, Yates χ2 and Fisher exact tests as apropriate. Also, a regression analysis (Poisson analysis) with the dependent significant variables. The established level of significance will be p < 0.05.

Women with measured menstrual bleeding >80ml per cycle and no contraindications to combined oral contraceptive use will be assigned to an oestradiol/nomegestrol acetate oral contraceptive for 3 cycles during which they will collect all menstrual blood and send all used sanitary protection to the laboratory at the University of Sydney for estimation of blood loss by the alkaline haematin method. Hypothesis: An estradiol/nomogestrel acetate (E2/NOMAC) combined pill will be effective in controlling HMB in the majority of women without structural pelvic pathology. Main outcome: The primary efficacy end-point will be the proportion of women with a reduction of menstrual blood loss ≥ 50% from baseline.

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)