Clinical trials: Menorrhagia
Uterine Fibroids and Heavy Menstrual Bleeding
A Study to Assess the Safety and Efficacy of Vilaprisan in Japanese Subjects With Uterine Fibroids and Heavy Menstrual Bleeding
To evaluate the safety and efficacy of vilaprisan in Japanese subjects with uterine fibroids and heavy menstrual bleeding (HMB).
- Trial name
- ASTEROID 8 (NCT03476928)
- Testing
- Vilaprisan (BAY1002670)
- Where
- 25 sites in Japan
- Volunteers
- 153 people
- Sponsor
- Bayer
Uterine Fibroid, Endometriosis
Bone Mineral Density in Women With Uterine Fibroids or Endometriosis
The purpose of this study is to characterize the longitudinal bone mineral density (BMD) in premenopausal women with uterine fibroids or endometriosis.
- Trial name
- NCT03744507
- Where
- 63 sites in United States, Australia and 5 more
- Volunteers
- 660 people
- Sponsor
- Myovant Sciences GmbH
Idiopathic Menorrhagia
MiCo - Mirena or Conventional Medical Treatment for Menorrhagia
The aim of this prospective, non-interventional post-marketing surveillance study is to obtain data on safety and efficacy of Mirena in treatment of heavy menstrual bleeding (Menorrhagia) under daily-life treatment conditions.For…
- Trial name
- NCT01085487
- Testing
- Levonorgestrel (Mirena, BAY86-5028), Hormonal treatment, Antifibrinolytic treatment
- Where
- 14 sites in Albania, Bosnia and Herzegovina and 12 more
- Volunteers
- 1,211 people
- Sponsor
- Bayer
Contraception, Menorrhagia
A Study to Evaluate the Effectiveness of Essure Post-NovaSure Radiofrequency Endometrial Ablation Procedure Following a Successful Essure Confirmation Test
The purpose of the post approval study is to evaluate the effectiveness and safety of the Essure System when a NovaSure Endometrial Ablation procedure is performed following a successful Essure Confirmation Test.
- Trial name
- ESS-NSPAS (NCT01740687)
- Testing
- ESS305 (Essure, BAY1454032), NovaSure
- Where
- 17 sites in United States
- Volunteers
- 211 people
- Sponsor
- Bayer
Menorrhagia, Metrorrhagia
Severity of Bleeding as a Predictor of Quality of Life (QoL) in Women With Heavy Menstrual Bleeding (HMB) Under Dydrogesterone Treatment
Dydrogesterone is a retroprogesterone with a molecular structure similar to natural progesterone. As a C-21 steroid, it has a high affinity for progesterone receptors, a low antigonadotropic activity and antiestrogenic activity…
- Trial name
- NCT01647360
- Where
- 20 sites in Pakistan
- Volunteers
- 210 people
- Sponsor
- Abbott
Menorrhagia
Evaluation of Modified Treatment Regimens for Treatment of Heavy Menstrual Bleeding Using the HerOption® System
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.
- Trial name
- NCT00094536
- Testing
- Extended treatment regimen using Her Option Cryotherapy
- Where
- 7 sites in United States
- Volunteers
- 82 people
- Sponsor
- CooperSurgical Inc.
Heavy Menstrual Bleeding, Uterine Fibroid
LIBERTY 1: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
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…
- Trial name
- NCT03049735
- Testing
- Relugolix, Estradiol/norethindrone acetate
- Where
- 110 sites in United States, Brazil and 4 more
- Volunteers
- 388 people
- Sponsor
- Myovant Sciences GmbH
Symptomatic Uterine Fibroids
Post Market TRUST - U.S.A. Study
This Post Market study is being conducted to compare the direct and indirect cost of three approaches (GFA, myomectomy, and uterine artery embolization) for the treatment of symptomatic uterine fibroids.
- Trial name
- NCT02163525
- Testing
- Global Fibroid Ablation (GFA), Abdominal or Laparoscopic Myomectomy, Uterine Artery Embolization (UAE)
- Where
- 9 sites in United States
- Volunteers
- 114 people
- Sponsor
- Acessa Health, Inc.
Uterine Fibroids (UF)
A Study to Evaluate Changes in Hair in Adult Participants Taking Oral Oriahnn Capsules With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF)
Uterine Fibroids (UF) are benign smooth muscle neoplasms of the uterus that affect women of reproductive age. UFs are one of the leading causes of hospitalizations for gynecological disorders and often lead to hysterectomy.
- Trial name
- Pink Orchid (NCT06058728)
- Where
- United States
- Sponsor
- AbbVie
Heavy Menstrual Bleeding
Therapeutic Equivalence Trial of Two Hormonal-IUDs in Patients With Heavy Menstrual Bleeding
The primary objective of this study was to compare the efficacy of Test Product (Levosert) vs. Reference Product (Mirena® Bayer-Schering) based on the mean variation of menstrual blood loss volume in women with menorrhagia.
- Trial name
- LVS-20 (NCT01695902)
- Testing
- Levosert-20, Mirena
- Volunteers
- 280 people
- Sponsor
- Uteron Pharma S.A.
Menorrhagia
A Clinical Study of the Aqua Therapeutics Thermal Therapy Vapor Ablation System in Premenopausal Women With Abnormal Uterine Bleeding
Abnormal uterine bleeding (AUB) is defined as "flow outside of normal volume, duration, regularity, or frequency". Acute AUB is excessive bleeding that requires immediate intervention to prevent further blood loss.
- Trial name
- AQTH-EA-PIV-24 (NCT07877051)
- Testing
- Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS)
- Where
- 3 sites in Georgia
- Volunteers
- 43 people
- Sponsor
- Aqua Therapeutics, Inc.
Menorrhagia, Heavy Menstrual Bleeding
Librata Endometrial Ablation Device Treatment to Reduce Menstrual Blood Loss
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…
- Trial name
- LEADER (NCT03725306)
- Testing
- Librata
- Volunteers
- 200 people
- Sponsor
- LiNA Medical
Menorrhagia, Heavy Menstrual Bleeding
Efficacy and Safety Study of XP12B in Women With Menorrhagia
The purpose of this study is to determine whether XP12B is effective and safe in the treatment of women with heavy menstrual bleeding associated with menorrhagia.
- Trial name
- NCT00386308
- Testing
- Tranexamic acid tablets
- Where
- 52 sites in United States
- Volunteers
- 196 people
- Sponsor
- Ferring Pharmaceuticals
Heavy Uterine Bleeding, Uterine Fibroids
Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids
The purpose of this proof-of-concept study is to assess the safety and effectiveness of elagolix versus placebo to reduce uterine bleeding associated with uterine fibroids, and to reduce fibroid volume and uterine volume in…
- Trial name
- NCT01441635
- Testing
- Elagolix, Estradiol/Norethindrone acetate (E2/NETA), Estradiol
- Volunteers
- 271 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Anemia
Comparison of the Safety and Efficacy of Intravenous Iron Versus Oral Iron in the Treatment of Anemia Secondary to Heavy Uterine Bleeding
This study compares of the safety and efficacy of intravenous iron vs oral iron in the treatment of anemia secondary to heavy uterine bleeding
- Trial name
- NCT00395993
- Testing
- Ferric Carboxymaltose (FCM), Ferrous Sulfate tablets
- Where
- United States
- Volunteers
- 456 people
- Sponsor
- American Regent, Inc.
Uterine Fibroids, Leiomyoma
Hysteroscopic Cryomyolysis for the Treatment of Submucosal Leiomyomata
The purpose of the current study is to evaluate the technical success, safety and procedure feasibility of hysteroscopic cryoablation treatment of symptomatic uterine fibroids in women who do not desire further pregnancies using…
- Conditions
- Uterine Fibroids, Leiomyoma, Menorrhagia
- Trial name
- NCT00731341
- Testing
- Cryoablation for the treatment of uterine fibroids
- Where
- Netherlands
- Volunteers
- 3 people
- Sponsor
- Boston Scientific Corporation
Menorrhagia
Post Approval NovaSure Essure Labeling Study
This post approval, observational study is being conducted to further evaluate the safety of the NovaSure Endometrial Ablation System when it is performed in the presence of Essure micro-inserts.
- Trial name
- PANEL (NCT01934244)
- Testing
- NovaSure Endometrial Ablation
- Where
- 14 sites in United States
- Volunteers
- 318 people
- Sponsor
- Hologic, Inc.
Menorrhagia
Registry Study of Genesys HTA for Treatment of Menorrhagia
This is a clinical registry of an FDA approved device system called the Genesys Hydro ThermAblatorTM (HTA) system (Boston Scientific).
- Trial name
- Genesys HTA (NCT01197547)
- Testing
- Genesys HTA
- Where
- 19 sites in United States
- Volunteers
- 1,014 people
- Sponsor
- Minerva Surgical, Inc.
Leiomyoma, Uterine Fibroids
Fibroid Ablation Study
The primary objective of this study is to establish the effectiveness and confirm the safety of the VizAblate System in ablating symptomatic uterine fibroids.
- Conditions
- Leiomyoma, Uterine Fibroids, Menorrhagia
- Trial name
- FAST-EU (NCT01226290)
- Testing
- VizAblate System
- Where
- 10 sites in Mexico, Netherlands and 1 more
- Volunteers
- 51 people
- Sponsor
- Gynesonics
Von Willebrand Disease (VWD), Heavy Menstrual Bleeding (HMB)
HMBeacon: A Phase 2 Study to Evaluate ALN-6400 in Adult and Adolescent Female Patients With VWD and HMB
The purpose of this study is to evaluate the safety, tolerability, efficacy, and pharmacodynamics (PD) of multiple doses of ALN-6400 in adult and adolescent patients with VWD and HMB
- Trial name
- HMBeacon (NCT07575308)
- Testing
- ALN-6400
- Where
- 21 sites in United States, Netherlands and 3 more
- Volunteers
- 24 people
- Sponsor
- Alnylam Pharmaceuticals