Clinical trials: Uterine Bleeding
Metrorrhagia
An Open-Label Study to Compare the Bleeding Profile of Norelgestromin/Ethinyl Estradiol in an Extended Regimen to Norelgestromin/Ethinyl Estradiol Given in a Traditional Regimen
The purpose of this study is to compare the bleeding profile of norelgestromin/ethinyl estradiol given in an extended continuous regimen to norelgestromin/ethinyl estradiol given in a traditional cyclic regimen
- Trial name
- NCT00320580
- Testing
- norelgestromin/ethinyl estradiol
- Volunteers
- 239 people, healthy volunteers welcome
- Sponsor
- McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Contraception, Menorrhagia
Bleeding Pattern and User Satisfaction During Second Consecutive MIRENA® in Contraception and Treatment of Menorrhagia
The purpose of this study is to assess the bleeding pattern during the last 3 months of the first MIRENA® and the first year of the second MIRENA® use.
- Trial name
- NCT00393198
- Testing
- Levonorgestrel (Mirena, BAY86-5028), Cytotec
- Where
- 17 sites in Finland, France and 2 more
- Volunteers
- 204 people
- Sponsor
- Bayer
Heavy Menstrual Bleeding, Uterine Fibroids
Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
The goal of this clinical trial is to determine the benefit of relugolix 40 milligrams (mg) once a day compared with placebo in heavy menstrual bleeding associated with uterine fibroids.
- Trial name
- NCT06671548
- Testing
- Relugolix
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
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.
Postpartum Uterine Bleeding
Belfort Dildy- Obstetrical Tamponade System Post-Marketing Surveillance Program
This is an open, post-marketing surveillance study obtaining data retrospectively on 300 women, of any age, treated with the BD-OTS for postpartum uterine bleeding.
- Trial name
- NCT01198652
- Where
- 11 sites in United States
- Volunteers
- 300 people
- Sponsor
- Glenveigh Medical
Uterine Bleeding Profile Prediction
A Study to Learn More About How a Smartphone App Called MyIUS Predicts Future Menstrual Bleeding in Women After They Have Begun Using Intrauterine Birth Control Method (a Birth Control Device is Inserted Into a Woman's Uterus by Her Doctor)
Researchers are looking to learn more about future menstrual bleeding in women who have started using intrauterine contraception methods.
- Trial name
- MyIUS (NCT04989595)
- Testing
- MyIUS app
- Where
- 6 sites in Brazil, Denmark and 4 more
- Volunteers
- 3,045 people, healthy volunteers welcome
- Sponsor
- Bayer
Adenomyosis
Placebo-controlled Proof of Concept Study of Epelsiban in Women With Adenomyosis
The primary objective of the study is to assess the efficacy, safety, and tolerability of epelsiban compared with placebo in treatment of women with adenomyosis.
- Trial name
- NCT02794467
- Testing
- Epelsiban
- Where
- 13 sites in United States
- Sponsor
- GlaxoSmithKline
Abnormal Uterine Bleeding, Endometriosis
Performance of SYMMCORA® vs. V-Loc® Suture Material in Patients Undergoing Laparoscopic Total Hysterectomy
The aim of this study is to show the superiority of the new unidirectional barbed suture (SYMMCORA® mid-term, unidirectional) to conventional suture material in terms of time to perform the vaginal cuff closure during gynecologic…
- Conditions
- Abnormal Uterine Bleeding, Endometriosis, Uterine Prolapse, Uterine Cancer
- Trial name
- BARHYSTER (NCT06024109)
- Testing
- Closure of the Vaginal Cuff after Total Hysterectomy
- Where
- 2 sites in Germany, Spain
- Volunteers
- 132 people
- Sponsor
- Aesculap AG
Heavy Menstrual Bleeding, Uterine Fibroid
LIBERTY EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
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…
- Trial name
- NCT03412890
- Testing
- Relugolix, Estradiol/norethindrone acetate
- Where
- 150 sites in United States, Belgium and 7 more
- Volunteers
- 477 people
- Sponsor
- Myovant Sciences GmbH
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
Fibroid Uterus, Leiomyoma
A Study to Evaluate of the Safety and Effectiveness of Asoprisnil in Treating Women With Uterine Fibroids
The objective of this study is to determine the safety and efficacy effects of two doses of asoprisnil (10 mg and 25 mg) compared with placebo when administered daily for 6 months to premenopausal subjects with symptomatic…
- Conditions
- Fibroid Uterus, Leiomyoma, Menorrhagia, Metrorrhagia
- Trial name
- NCT00152256
- Testing
- Asoprisnil
- Volunteers
- 239 people
- Sponsor
- Abbott
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.
Post Partum Hemorrhage
Sublingual Oxytocin for the Prevention of Post-partum Hemorrhage
An open-label, randomized, single-center, dose ascending trial will be conducted to evaluate the efficacy and safety of sublingual oxytocin for the prevention of post-partum hemorrhage caused by uterine atony in term pregnant…
- Trial name
- NCT06968481
- Testing
- Oxytocin sublingual, Oxytocin IM
- Where
- Nigeria
- Volunteers
- 330 people
- Sponsor
- Insud Pharma
Premenopause, Iron-deficiency
A Clinical Study on Adherence and Efficacy of Different Doses of Active Iron in Treatment Resistant Subjects
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.
- Conditions
- Premenopause, Iron-deficiency, Iron Adverse Reaction, Iron Deficiency Anemia
- Trial name
- NCT04778072
- Testing
- Ferrous sulfate 14mg once daily, Ferrous sulfate 25mg once daily, Ferrous sulfate 25mg twice daily
- Where
- Ireland
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Solvotrin Innovations Ltd
Postpartum Hemorrhage
RUBY Post-Market Registry on the Jada® System
The RUBY Study is a multicenter, observational, post-market registry designed to collect observational data on patients treated with the Jada System in the post-market setting.
- Trial name
- RUBY (NCT04995887)
- Testing
- Jada® System
- Where
- 16 sites in United States
- Volunteers
- 809 people
- Sponsor
- Alydia Health
Post Partum Haemorrhage, Maternal Care Patterns
Pivotal, Prospective, Multi-centre, Single-arm Study to Evaluate the Safety and Effectiveness of Oli for Identification of Patients, During the Intrapartum Period, Who Are at Higher Risk of Developing Abnormal Postpartum Uterine Bleeding, Including Postpartum Haemorrhage
Oli is a predictive, non-invasive device, intended to be placed on the participant's maternal abdomen during the intrapartum period, which can alert healthcare professionals of an impending cumulative blood loss of ≥500 ml…
- Conditions
- Post Partum Haemorrhage, Maternal Care Patterns, High Risk Pregnancy
- Trial name
- NCT06655207
- Testing
- Oli is a non-invasive, wearable device, designed to provide clinicians with an early indication if the participant is at a higher risk of developing abnormal postpartum uterine bleeding
- Where
- 7 sites in United States, Australia
- Volunteers
- 1,000 people
- Sponsor
- Baymatob Operations Pty Ltd
Contraception
Mirena Extension Trial
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…
- Trial name
- MET (NCT02985541)
- Testing
- Levonorgestrel IUS (Mirena, BAY86-5028)
- Where
- 49 sites in United States
- Volunteers
- 364 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
Uterine Fibroids
A Study to Evaluate the Safety and Efficacy of Elagolix for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women
The main objective of this study is to assess safety and efficacy of elagolix compared to placebo in reducing heavy menstrual bleeding (HMB) associated with uterine fibroids in premenopausal women.
- Trial name
- NCT03886220
- Testing
- Elagolix
- Where
- 48 sites in United States, Puerto Rico
- Volunteers
- 82 people
- Sponsor
- AbbVie