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Menorrhagia clinical trials

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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: NCT03272568 Completed - Hemophilia Clinical Trials

Extended Half Life Factor (EHF) Products For Heavy Menstrual Bleeding in Hemophilia Carriers

Start date: February 14, 2018
Phase: Early Phase 1
Study type: Interventional

The purpose of this feasibility study is to find out if two clotting factor products, Eloctate [hemophilia A] and Alprolix [hemophilia B], can reduce the amount of menstrual bleeding in female hemophilia A and B carriers (14 years of age or older) who have severe or heavy bleeding. These products are FDA-approved for use in males with hemophilia A and B to prevent and treat bleeding. They are not approved specifically to reduce menstrual bleeding, but may be useful for this purpose. Both products have an "extended half life" which means they circulate in the body longer than other FVIII or FIX products. The study team will gather additional information about the safety of these drugs and how well they work. The results of this feasibility study will provide information for an upcoming larger study.

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.

NCT ID: NCT03049735 Completed - Uterine Fibroid Clinical Trials

LIBERTY 1: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

Start date: April 26, 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: NCT02985541 Completed - Contraception Clinical Trials

Mirena Extension Trial

MET
Start date: December 22, 2016
Phase: Phase 3
Study type: Interventional

The study is performed to assess if Mirena is effective and safe as a birth control method beyond 5 years of use. Further the menstrual blood loss (in women that had Mirena inserted for the indication heavy menstrual bleeding [HMB]) and safety will be assessed.

NCT ID: NCT02943655 Completed - Clinical trials for Heavy Menstrual Bleeding

Treatment of Heavy and/or Prolonged Menstrual Bleeding Without Organic Cause

Start date: November 1, 2017
Phase: Phase 3
Study type: Interventional

Abnormal uterine bleeding encompasses abnormalities in the regularity, duration of flow, frequency, and/or blood flow volume relative to normal menstruation. Of these menstrual abnormalities, heavy menstrual bleeding (HMB), defined objectively as a blood loss of 80 ml or more per menstrual cycle , which is unrelated to pregnancy or known pelvic or systemic disease.