Clinical trials: Menstrual Bleeding, Heavy
Menorrhagia, Metrorrhagia
Tamoxifen to Reduce Unscheduled Bleeding in New Users of the Levonorgestrel-releasing Intrauterine System (LNG-IUS)
This study evaluates the ability of tamoxifen to improve frequent or prolonged bleeding in new users of the 52mg levonorgestrel-releasing intrauterine device (IUD).
- Conditions
- Menorrhagia, Metrorrhagia, Medicated Intrauterine Devices
- Trial name
- NCT02824224
- Testing
- Tamoxifen
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Oregon Health and Science University
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
Venous Thromboembolism, Menstruation
RAMBLE - Rivaroxaban vs. Apixaban for Heavy Menstrual Bleeding
A large proportion of women with menstruating potential with newly diagnosed VTE or atrial fibrillation, treated with apixaban will have less menstrual blood loss than patients randomized to rivaroxaban.
- Trial name
- (RAMBLE) (NCT02829957)
- Testing
- Apixaban, Rivaroxaban
- Where
- 2 sites in United States
- Volunteers
- 19 people
- Sponsor
- Indiana University
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
Menorrhagia
Minerva Pivotal Study to Evaluate Safety and Efficacy of the Aurora Endometrial Ablation System Compared to Hysteroscopic Rollerball Ablation
The primary objective of this study is to evaluate the safety and effectiveness of the Aurora Endometrial Ablation System as compared to hysteroscopic rollerball endometrial ablation in reducing menstrual blood loss at 12 months…
- Trial name
- NCT01569763
- Testing
- Aurora Endometrial Ablation, Rollerball Ablation/Resection
- Where
- 13 sites in United States, Canada and 1 more
- Volunteers
- 153 people
- Sponsor
- Minerva Surgical, Inc.
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
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
Uterine Leiomyoma, Uterine Fibroids
Study of Relugolix With Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
The objectives of this randomized withdrawal study are to evaluate the long-term efficacy and safety of the combination of relugolix, estradiol (E2) and norethindrone acetate (NETA), once daily, for up to 104 weeks in patients…
- Trial name
- NCT03751124
- Testing
- Relugolix, Estradiol/norethindrone acetate
- Where
- 104 sites in United States, Brazil and 6 more
- Volunteers
- 229 people
- Sponsor
- Myovant Sciences GmbH
Menorrhagia
Study of a Levonorgestrel 52 mg Intrauterine System for the Treatment of Heavy Menstrual Bleeding
To assess the efficacy of a levonorgestrel 52 mg intrauterine system as a treatment for heavy menstrual bleeding.
- Trial name
- NCT03642210
- Testing
- Levonorgestrel 52 mg intrauterine system
- Where
- 29 sites in United States
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- Medicines360
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
Menorrhagia
Tranexamic Acid (TA) vs Combined Oral Contraceptive (COCP) Pilot Study
Menorrhagia, considered a public health challenge and reported by 5 to 10% of adult women, is encountered even more frequently in adolescents.
- Trial name
- NCT01428713
- Testing
- Oral tranexamic acid, Oral Contraceptive Pills
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Baylor College of Medicine
Aplastic Anemia, Menorrhagia
Treatment of Menorrhagia in Women With Thrombocytopenia Using Platelets or Platelets and Hormones
This study will explore the role of oral contraceptive pills in managing uterine bleeding in women who have low blood platelet counts as a result of aplastic anemia.
- Conditions
- Aplastic Anemia, Menorrhagia, Amenorrhea
- Trial name
- NCT00556400
- Testing
- Lo-Ovral Oral Contraceptive Pills
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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
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
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
Relationship Between Bladder Distention and Hysteroscopy Application
The purpose of the study is to investigate the advantages and disadvantages of bladder filling during hysteroscopy procedure.
- Trial name
- NCT01848847
- Testing
- Hysteroscopy
- Where
- Turkey (Türkiye)
- Volunteers
- 102 people
- Sponsor
- Namik Kemal University