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Heavy Menstrual Bleeding clinical trials

View clinical trials related to Heavy Menstrual Bleeding.

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NCT ID: NCT04132349 Terminated - Uterine Fibroid Clinical Trials

Ulipristal Acetate in Symptomatic Uterine Fibroid

Start date: October 23, 2019
Phase: Phase 4
Study type: Interventional

This study evaluates the effectiveness and safety of ulipristal acetae (UPA) in women with symptomatic uterine fibroids. Those who fulfilled inclusion/exclusion criteria will be treated UPA at daily dose of 5mg.

NCT ID: NCT03725306 Not yet recruiting - Menorrhagia Clinical Trials

Librata Endometrial Ablation Device Treatment to Reduce Menstrual Blood Loss

LEADER
Start date: January 1, 2019
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT03412890 Completed - Uterine Fibroid Clinical Trials

LIBERTY EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

Start date: October 19, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study was to determine the long-term efficacy and safety of relugolix 40 milligrams (mg) once daily co-administered with estradiol (E2) and norethindrone acetate (NETA) for 28 weeks on heavy menstrual bleeding associated with uterine fibroids in participants who previously completed a 24-week treatment period in one of the pivotal studies (MVT-601-3001 or MVT-601-3002).

NCT ID: NCT03368898 Completed - Clinical trials for Heavy Menstrual Bleeding

Quality of Life in Premenopausal Women With Heavy Menstrual Bleeding

Start date: January 1, 2017
Phase:
Study type: Observational [Patient Registry]

Heavy menstrual bleeding or menorrhagia, is a common problem on women's lives and can burden both patients and health care systems. HMB is defined as cyclic heavy vaginal bleeding. Hormonal treatment of heavy menstrual bleeding (HMB) is also endorsed as the first line treatment in several international guidelines. The effects of these therapies on bleeding related quality of life are not well known. The aim of the present study is compare the effect of Estradiol Valerate/Dienogest (E2V/DNG), Levonorgestrel-Intrauterine Device (LNG-IUD) and oral micronized progesterone treatment on bleeding pattern, cycle control, menopausal symptoms and patient satisfaction of women with HMB.

NCT ID: NCT03317795 Completed - Uterine Fibroids Clinical Trials

Treatment of Heavy Menstrual Bleeding in Women With Uterine Fibroids

Start date: November 14, 2017
Phase: Phase 4
Study type: Interventional

This is a randomized controlled trial (RCT) to assess the comparative effectiveness of Levonorgestrel Intrauterine System (LNG-IUS) to Tranexamic Acid (TA) for the treatment of heavy menstrual bleeding (HMB) in women with clinically-significant fibroids.

NCT ID: NCT03271489 Active, not recruiting - Uterine Fibroids Clinical Trials

Long-Term Safety Study of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

Start date: January 4, 2017
Phase: Phase 3
Study type: Interventional

This is phase 3b study seeks to evaluate the safety of elagolix in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women. This study is double-blinded in the first year and an open-label for the next three years.

NCT ID: NCT03186586 Recruiting - Clinical trials for Heavy Menstrual Bleeding

Ulipristal Versus Placebo for Women With Bleeding Induced by Mirena

Start date: July 1, 2017
Phase: Phase 4
Study type: Interventional

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.

NCT ID: NCT03103087 Completed - Uterine Fibroid Clinical Trials

LIBERTY 2: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

Start date: June 14, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the benefit of relugolix 40 milligrams (mg) once a day co-administered with estradiol (E2) 1 mg and norethindrone acetate (NETA) 0.5 mg compared with placebo for 24 weeks on heavy menstrual bleeding associated with uterine fibroids.

NCT ID: NCT03070951 Completed - Uterine Fibroids Clinical Trials

Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids

PRIMROSE 2
Start date: May 23, 2017
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to demonstrate the superior efficacy versus placebo of OBE2109 alone and in combination with add-back therapy for the reduction of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.

NCT ID: NCT03070899 Completed - Uterine Fibroids Clinical Trials

Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids

PRIMROSE 1
Start date: April 20, 2017
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to demonstrate the superior efficacy versus placebo of OBE2109 alone and in combination with add-back therapy for the reduction of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.