Clinical trials: Menstruation
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, Heavy Menstrual Bleeding
Minitouch Endometrial Ablation System Treatment for Menorrhagia: An Evaluation of Safety & Effectiveness
The EASE Clinical Trial is prospective, multi-center, single-arm (open-label), non-randomized, clinical trial to evaluate the Minitouch Endometrial Ablation System ("Minitouch System") in premenopausal women with menorrhagia.
- Conditions
- Menorrhagia, Heavy Menstrual Bleeding, Heavy Uterine Bleeding
- Trial name
- NCT04267562
- Testing
- Minitouch System
- Where
- 5 sites in United States
- Volunteers
- 219 people, healthy volunteers welcome
- Sponsor
- MicroCube, LLC
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.
Endometriosis
Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Adults With Moderate to Severe Endometriosis-Associated Pain
A randomized study evaluating the continued safety and efficacy of elagolix in the management of moderate to severe endometriosis-associated pain in pre-menopausal women.
- Trial name
- NCT01760954
- Testing
- Elagolix
- Volunteers
- 506 people
- Sponsor
- AbbVie
Dysmenorrhea
Study to Assess the Safety and Efficacy of Etoricoxib Versus Ibuprofen in the Treatment of Dysmenorrhea (MK-0663-145 AM1)
This is a study to determine the overall analgesic effect of a single oral dose of etoricoxib compared to ibuprofen in participants with moderate-to-severe primary dysmenorrhea.
- Trial name
- NCT01462370
- Testing
- Etoricoxib, Ibuprofen, Acetaminophen 250 mg, isopropylantipyrine 150 mg and anhydrous caffeine 50 mg
- Volunteers
- 139 people
- Sponsor
- Organon and Co
Dysmenorrhea
A Study to Evaluate the Effect of Contraceptive Vaginal Rings on Primary Dysmenorrhea (P08257/MK-8175A/MK-8342B-057)
The study investigates four vaginal ring groups with respect to relief of primary dysmenorrhea, and should identify at least one vaginal ring that shows clinically relevant treatment efficacy in relief of primary dysmenorrhea.
- Trial name
- NCT01670656
- Testing
- Nomegestrol acetate contraceptive vaginal ring (NOMAC-CVR), Etonogestrel containing contraceptive vaginal ring (ENG-CVR), Ibuprofen
- Volunteers
- 439 people
- Sponsor
- Organon and Co
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)
Menorrhagia
A Study of Tranexamic Acid (XP12B) in Women With Heavy Menstrual Bleeding
This was a multicenter, open-label extension study for subjects completing either of 2 pivotal efficacy studies (NCT00401193 or NCT00386308).
- Trial name
- NCT01280981
- Testing
- Tranexamic acid
- Where
- 92 sites in United States
- Volunteers
- 288 people
- Sponsor
- Ferring Pharmaceuticals
Menorrhagia, Heavy Menstrual Bleeding
Safety Study of XP12B in Women With Menorrhagia
The purpose of this study is to evaluate the safety of XP12B in women with heavy menstrual bleeding associated with menorrhagia.
- Trial name
- NCT00113568
- Testing
- Tranexamic acid tablets (XP12B)
- Where
- 59 sites in United States
- Volunteers
- 784 people
- Sponsor
- Ferring Pharmaceuticals
Heavy Menstrual Bleeding, Uterine Fibroid
LIBERTY 2: 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
- NCT03103087
- Testing
- Relugolix, Estradiol/norethindrone acetate
- Where
- 127 sites in United States, Belgium and 6 more
- Volunteers
- 382 people
- Sponsor
- Myovant Sciences GmbH
Endometriosis
A Study to Assess the Efficacy and Safety of OBE2109 in Subjects With Endometriosis
The primary objective of this study is to assess the efficacy and safety of a range of oral doses of OBE2109 versus placebo, in reducing endometriosis associated pain.
- Trial name
- EDELWEISS (NCT02778399)
- Testing
- OBE2109
- Where
- 86 sites in United States, Poland and 2 more
- Volunteers
- 328 people
- Sponsor
- ObsEva SA
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
Vaginal Microflora
Clinical Evaluation of Effects of an Investigational Tampon on Vaginal Microflora
Subjects will be using investigational or control tampons during their menstrual period but these tampons are not intended to prevent, treat or diagnose an infection or other disease condition.
- Trial name
- NCT00913523
- Testing
- Experimental - Tampon with GML
- Where
- 2 sites in United States
- Volunteers
- 482 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Consumer and Personal Products Worldwide
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
Endometriosis-related Pain
Randomized Trial Assessing Quinagolide Vaginal Ring for Endometriosis-related Pain
To evaluate the efficacy of three doses of quinagolide administered as an extended-release vaginal ring compared to placebo on reduction of moderate to severe endometriosis-related pain
- Trial name
- RAQUEL (NCT03692403)
- Testing
- Quinagolide 360 µg, Quinagolide 720 µg, Quinagolide 1080 µg
- Where
- 43 sites in United States
- Volunteers
- 22 people
- Sponsor
- Ferring Pharmaceuticals
Dysmenorrhea
SH T00186 Phase II/ III Optimal Drospirenone (DRSP) Dose Finding and Placebo-controlled Comparative Study
The purpose of this study is to investigate efficacy of drospirenone for dysmenorrhea.
- Trial name
- NCT00511797
- Testing
- SH T04740B, SH T00186DF, SH T04740F
- Where
- 12 sites in Japan
- Volunteers
- 249 people
- Sponsor
- Bayer
Endometriosis
A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Participants With Moderate to Severe Endometriosis-Associated Pain
The objective of this study is to evaluate safety and efficacy of elagolix in the management of moderate to severe endometriosis-associated pain in adult premenopausal female participants including the safety and efficacy of…
- Trial name
- NCT03213457
- Testing
- Estradiol/Norethindrone Acetate, Elagolix
- Where
- 197 sites in United States, Canada and 1 more
- Volunteers
- 681 people
- Sponsor
- AbbVie
Endometriosis
A Phase 3 Study to Confirm the Efficacy and Safety of Linzagolix to Treat Endometriosis-associated Pain
The primary objective of this study is to demonstrate the efficacy and safety of linzagolix administered orally once daily for 3 months at a dose of 75 mg alone or of 200 mg in combination with add-back hormone replacement…
- Trial name
- NCT03986944
- Testing
- 75 mg linzagolix tablet, 200 mg linzagolix tablet, Add-back capsule (E2 1 mg / NETA 0.5 mg)
- Where
- 112 sites in United States, Canada and 1 more
- Volunteers
- 85 people
- Sponsor
- Kissei Pharmaceutical Co., Ltd.
Menorrhagia Due to Benign Causes
A Two-Phase Clinical Study of the Minerva AURORA Ablation System
The primary objective of this study is to evaluate the use of the Aurora Ablation System in reducing menstrual blood loss at 12 months post-treatment.
- Trial name
- NCT02035332
- Testing
- Aurora Endometrial Ablation System
- Where
- 3 sites in Hungary
- Volunteers
- 23 people
- Sponsor
- Minerva Surgical, Inc.
Dysmenorrhea
A Comparison Study of Pain Relief From Dysmenorrhea Between the Vipon Tampon and Ibuprofen
The purpose of this study is to compare the Vipon tampon with ibuprofen in relieving pain in women with dysmenorrhea. Subjects completed a total of 4 treatment intervals; each subject was randomized to use the VIPON as their…
- Trial name
- NCT00951561
- Testing
- Vipon, Ibuprofen
- Where
- 2 sites in United States
- Volunteers
- 115 people, healthy volunteers welcome
- Sponsor
- Another Way Products