Clinical trials: Menorrhagia
Menorrhagia Due to Benign Causes
A Multi-Center, Single Arm Clinical Study of the Safety and Efficacy of the AURORA™ Endometrial Ablation System
This is a multi-center, single-arm, non-randomized, prospective clinical study. The clinical study is designed as a non-inferiority study to assess the effectiveness of the Aurora Endometrial Ablation System compared to an…
- Trial name
- NCT02029911
- Testing
- Aurora Endometrial Ablation System
- Where
- 3 sites in Canada
- Volunteers
- 63 people
- Sponsor
- Minerva Surgical, Inc.
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
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
Menorrhagia
Survey on Patient Satisfaction Rate for Mirena Use in Heavy Menstrual Bleeding
The purposes of this study are: To evaluate patient satisfaction for efficacy and tolerability of heavy menstrual bleeding treatment by Mirena. To collect italian data for Mirena in clinical routine.
- Trial name
- NCT00874653
- Testing
- Levonorgestrel (Mirena, BAY86-5028)
- Where
- Italy
- Volunteers
- 78 people
- Sponsor
- Bayer
Idiopathic Menorrhagia
Mirena in Idiopathic Menorrhagia
This is an open-label, uncontrolled, multi-centre observational study that analyses a follow-up of 1600 women with dysfunctional uterine bleeding (idiopathic menorrhagia) over a period of one year.The patients evaluated at four…
- Trial name
- NCT00868153
- Testing
- Levonorgestrel IUS (Mirena , BAY86-5028)
- Where
- 13 sites in Bulgaria, Croatia and 11 more
- Volunteers
- 1,125 people
- Sponsor
- Bayer
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.
Menorrhagia, Heavy Menstrual Bleeding
Efficacy and Safety 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
- NCT00401193
- Testing
- Tranexamic acid tablets
- Where
- 83 sites in United States
- Volunteers
- 304 people
- Sponsor
- Ferring Pharmaceuticals
Uterine Fibroids
Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 3)
The primary objective of this study was to show superiority in the treatment of HMB of vilaprisan in subjects with uterine fibroids compared to placebo.
- Trial name
- NCT03400943
- Testing
- Vilaprisan (BAY1002670)
- Where
- 103 sites in United States, Bulgaria and 7 more
- Volunteers
- 93 people
- Sponsor
- Bayer
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
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
Uterine Fibroids, Heavy Menstrual Bleeding
An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
This is an extension study for women who have already received six months of treatment in the phase III clinical trial M12-815 (NCT02654054) or M12-817 (NCT02691494), and will evaluate the long-term efficacy and safety of…
- Trial name
- NCT02925494
- Testing
- Estradiol/Norethindrone Acetate, Elagolix
- Where
- 124 sites in United States, Canada and 1 more
- Volunteers
- 433 people
- Sponsor
- AbbVie
Uterine Fibroids
Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 4)
The primary objective of this study was to show superiority of vilaprisan in the treatment of heavy menstrual bleeding (HMB) in subjects with uterine fibroids compared to placebo The secondary objectives of this study were to…
- Trial name
- NCT03400956
- Testing
- Vilaprisan (BAY1002670)
- Where
- 87 sites in United States, Czechia and 3 more
- Volunteers
- 103 people
- Sponsor
- Bayer
Fibroid Uterus, Leiomyoma
Safety of Treatment of Uterine Fibroids With Asoprisnil
The objective of this study is to determine the long-term safety of asoprisnil in women with symptomatic uterine fibroids who completed the 6 month Study C02-037.
- Conditions
- Fibroid Uterus, Leiomyoma, Menorrhagia, Metrorrhagia
- Trial name
- NCT00156208
- Testing
- Asoprisnil
- Volunteers
- 166 people
- Sponsor
- Abbott
Uterine Fibroids, Endometriosis
A Phase 3B Study to Evaluate Bone Mineral Density With Long-Term Use of Relugolix Combination Tablet in Women With Uterine Fibroids or Endometriosis
The purpose of this clinical trial to characterize changes in bone mineral density during continuous treatment with relugolix combination tablet for up to 48 months (4 years) and 1 year of post-treatment follow-up in…
- Trial name
- NCT05862272
- Testing
- Relugolix Combination Tablet
- Where
- 120 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Sumitomo Pharma Switzerland GmbH
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.
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
Leiomyoma, Uterine Fibroids
Safety and Effectiveness Study of RF Ablation of Uterine Fibroids to Reduce Menstrual Bleeding: the Fibroid Ablation Study
The primary objective of this study is to test the hypothesis that a minimum 75% volume radiofrequency ablation of fibroids associated with menorrhagia results in reduction of menstrual bleeding.
- Conditions
- Leiomyoma, Uterine Fibroids, Menorrhagia
- Trial name
- FAST (NCT00768742)
- Testing
- VizAblate Intrauterine Ultrasound-Guided RF Ablation
- Where
- 3 sites in Canada
- Sponsor
- Gynesonics