Clinical trials: Heavy Menstrual Bleeding (HMB)
Heavy Menstrual Bleeding
Juveena Hydrogel System Feasibility Study for Heavy Menstrual Bleeding (HMB)
This is a prospective, multicenter, single-arm interventional feasibility study to evaluate the safety and feasibility of the Juveena Hydrogel System for temporary control of heavy menstrual bleeding (HMB) in women with a history…
- Trial name
- NCT06634719
- Testing
- Juveena Hydrogel System
- Where
- 3 sites in United States
- Volunteers
- 13 people
- Sponsor
- Rejoni Inc.
Heavy Menstrual Bleeding
IUB SEAD RED (Revolutionary Endometrial Ablation Device Study
One of the AUB symptoms, heavy menstrual bleeding (HMB), can lead to iron deficiency and iron deficiency anemia and in acute and severe cases, can necessitate emergency medical care.
- Trial name
- HMB (NCT04959396)
- Testing
- IUB SEAD
- Where
- 9 sites in Georgia, Israel
- Volunteers
- 30 people
- Sponsor
- Ocon Medical Ltd.
Heavy Uterine Bleeding, Uterine Fibroids
Safety and Efficacy in Premenopausal Women With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF)
This is a Phase 2b randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of elagolix alone and in combination with add-back therapy versus placebo on heavy menstrual bleeding in premenopausal women…
- Trial name
- NCT01817530
- Testing
- Elagolix, 0.5 mg estradiol / 0.1 mg norethindrone acetate, 1 mg estradiol / 0.5 mg norethindrone acetate
- Volunteers
- 571 people
- Sponsor
- AbbVie
Uterine Fibroids, Heavy Menstrual Bleeding
Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women (Replicate Study)
This study seeks to evaluate the efficacy, safety and tolerability of elagolix alone and in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in…
- Trial name
- NCT02691494
- Testing
- Elagolix, Estradiol/Norethindrone Acetate
- Where
- 105 sites in United States, Canada
- Volunteers
- 378 people
- Sponsor
- AbbVie
Heavy Menstrual Bleeding, Uterine Fibroids
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
This randomized multicenter 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…
- Trial name
- NCT03271489
- Testing
- Elagolix, Estradiol /norethindrone acetate (E2/NETA)
- Where
- 157 sites in United States, Puerto Rico
- Volunteers
- 478 people
- Sponsor
- AbbVie
Menorrhagia
A Study Run at Multiple Study Sites to Test Whether the SAMANTA Questionnaire That is Used to Diagnose Heavy Menstrual Bleeding (HMB), Can Also be Used to Assess Changes of Severity of HMB in Women With HMB Who Are Treated During 12 Months With a Chronic Hormonal Treatment
A study run at multiple study sites in Spain to test whether the SAMANTA questionnaire that is used to diagnose heavy menstrual bleeding (HMB), can also be used to assess changes of severity of HMB in women with HMB who are…
- Trial name
- SAMIRA (NCT03751800)
- Testing
- Chronic hormonal treatment
- Where
- Spain
- Volunteers
- 422 people
- Sponsor
- Bayer
Uterine Fibroids, Heavy Menstrual Bleeding
Efficacy and 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 seeks to evaluate the efficacy, safety and tolerability of elagolix alone and in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in…
- Trial name
- NCT02654054
- Testing
- Elagolix, Estradiol/Norethindrone Acetate
- Where
- 96 sites in United States, Canada and 1 more
- Volunteers
- 413 people
- Sponsor
- AbbVie
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
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
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
Heavy Menstrual Bleeding, Uterine Fibroids
A Study to Assess Patient-Reported Quality of Life and Effectiveness on Control of Bleeding in Adult Participants With Heavy Menstrual Bleeding Due to Uterine Fibroids Taking Oral Oriahnn Capsules
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…
- Trial name
- REACH (NCT05026502)
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- AbbVie
Uterine Fibroids, Heavy Menstrual Bleeding
Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids
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…
- Trial name
- PRIMROSE 1 (NCT03070899)
- Testing
- OBE2109, Add-back
- Where
- 116 sites in United States
- Volunteers
- 526 people
- Sponsor
- ObsEva SA
Menorrhagia
Sonography Guided Transcervical Ablation of Uterine Fibroids
The objective of this study is to establish the safety and effectiveness of the Sonata® System in the treatment of symptomatic uterine fibroids.
- Trial name
- SONATA (NCT02228174)
- Testing
- Intrauterine Ultrasound-Guided Radiofreq. Ablation System
- Where
- 23 sites in United States, Mexico
- Volunteers
- 147 people
- Sponsor
- Gynesonics
Heavy Menstrual Bleeding
Delivering tAN to Reduce HMB: The LUNA Study
The LUNA study is a prospective, randomized, double-blind, sham-controlled, decentralized clinical trial in participants with heavy menstrual bleeding of no known structural cause.
- Trial name
- LUNA (NCT07326722)
- Testing
- Sparrow Link
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Spark Biomedical, Inc.
Uterine Fibroids, Heavy Menstrual Bleeding
Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids
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…
- Trial name
- PRIMROSE 2 (NCT03070951)
- Testing
- OBE2109, Add-back
- Where
- 96 sites in United States, Bulgaria and 7 more
- Volunteers
- 511 people
- Sponsor
- ObsEva SA
Heavy Menstrual Bleeding
A Study Called Champion-HMB to Learn More About Females With Heavy Menstrual Bleeding and Available Treatments to Enable Earlier Diagnosis and to Predict Courses of Treatment
This is an observational study in which patient data from the past of females with heavy menstrual bleeding (HMB) is studied. HMB describes menstrual periods with abnormally heavy or prolonged bleeding.
- Trial name
- Champion-HMB (NCT05176496)
- Where
- Germany
- Volunteers
- 99,999 people
- Sponsor
- Bayer
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