Clinical trials: Menstrual Symptoms
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
Amenorrhea
Determination of the Lowest, Safe and Effective Dose of Proellex
The purpose of this study is to determine the effects of five different doses of Proellex on menses, ovulation, liver function, and steady state exposure in women of reproductive age.
- Trial name
- NCT01187043
- Testing
- Proellex
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Repros Therapeutics Inc.
Amenorrhea
Study to Evaluate Menses Induction in Women Administered Proellex
The purpose of this study is to determine the oral dose level at which the investigative drug, Proellex, is able induce menstruation.
- Trial name
- NCT00881608
- Testing
- Proellex
- Where
- United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Repros Therapeutics Inc.
Pelvic Pain Associated With Refractory Endometriosis
A Safety & Efficacy Study of BGS649 in Women With Refractory Endometriosis
The purpose of this study is to determine efficacy, safety, tolerability and pharmacokinetics of multiple doses of BGS649 with concurrent daily administration of combined oral contraception in patients with refractory…
- Trial name
- NCT01116440
- Testing
- BGS649
- Where
- 44 sites in United States, Puerto Rico
- Volunteers
- 27 people
- Sponsor
- Mereo BioPharma
Endometriosis
Extension to Study on Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain (EDELWEISS 6)
The primary objective of this extension study is to assess the maintenance of efficacy of linzagolix administered orally once daily for up to an additional 6 months (for up to 12 months of treatment in total) in women who have…
- Trial name
- NCT04335591
- Testing
- 75 mg linzagolix tablet, 200 mg linzagolix tablet, Add-back capsule (E2 1 mg / NETA 0.5 mg)
- Where
- 47 sites in United States, Austria and 7 more
- Volunteers
- 356 people
- Sponsor
- Kissei Pharmaceutical Co., Ltd.
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
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
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
Menorrhagia
Study in Women With Idiopathic Menorrhagia to Determine the Reduction in Menstrual Blood Loss (MBL) After Treatment With the Levonorgestrel-releasing Intrauterine System (IUS)
The purpose of this study is to determine whether the levonorgestrel-releasing intrauterine system is effective in decreasing menstrual blood loss.
- Trial name
- NCT00360490
- Testing
- Levonorgestrel IUS (Mirena, BAY86-5028), Medroxyprogesterone acetate
- Where
- 54 sites in United States, Argentina and 3 more
- Volunteers
- 165 people
- Sponsor
- Bayer
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
Efficacy and Safety of Linzagolix for the Treatment of 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
- NCT03992846
- Testing
- 75 mg linzagolix tablet, 200 mg linzagolix tablet, Add-back capsule (E2 1 mg / NETA 0.5 mg)
- Where
- 71 sites in United States, Austria and 8 more
- Volunteers
- 486 people
- Sponsor
- Kissei Pharmaceutical Co., Ltd.
Menorrhagia
A CLinical Study to Evaluate the Safety And Effectiveness of the CeRene DevIce to Treat HeavY Menstrual Bleeding
The purpose of the study is to evaluate the safety and effectiveness of the Cerene Cryotherapy Device in reducing menstrual bleeding in women with heavy menstrual bleeding (menorrhagia) due to benign causes for whom child bearing…
- Trial name
- CLARITY (NCT02842736)
- Testing
- Cerene(R) Cryotherapy Device
- Where
- 12 sites in United States, Canada and 1 more
- Volunteers
- 242 people
- Sponsor
- Channel Medsystems
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
Dysmenorrhea
Efficacy and Safety of Etonogestrel + 17β-Estradiol Vaginal Ring (MK-8342B) in the Treatment of Women With Primary Dysmenorrhea (MK-8342B-060)
The purpose of this study was to evaluate the efficacy of the etonogestrel (ENG) + 17β-estradiol (E2) (MK-8342B) vaginal ring compared to placebo vaginal ring in the treatment of dysmenorrhea at Treatment Cycle 2.
- Trial name
- NCT02668822
- Testing
- ENG 125 μg + E2 300 μg vaginal ring (MK-8342B), Ibuprofen
- Volunteers
- 18 people
- Sponsor
- Organon and Co
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
Dysmenorrhea
Effectiveness of Nanoone Woman Underwear Using in the Management of Dysmenorrhea
To evaluate the mean change in menstrual pain intensity during menstrual cycles from baseline after wearing Nanoone Woman Underwear in women with primary dysmenorrhea
- Trial name
- NCT01449305
- Testing
- Nanoone Woman Underwear
- Where
- Taiwan
- Volunteers
- 44 people
- Sponsor
- Chen Yi Enterprise, Co., Ltd.
Dysmenorrhea
A Study to Evaluate the Efficacy of Seasonique for the Treatment of Cyclic Pelvic Pain
This study is being conducted to evaluate the effects of treatment with Seasonique an extended-regimen oral contraceptive that utilizes low dose ethinyl estradiol during the typical hormone-free interval.
- Trial name
- NCT00196313
- Testing
- levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets
- Where
- 13 sites in United States
- Volunteers
- 95 people
- Sponsor
- Duramed Research
Dysmenorrhea
Safety Study of Ethinylestradiol/Drospirenone in Dysmenorrhea
The purpose of this study is to investigate efficacy of ethinylestradiol for intracyclic bleeding profile in patients with dysmenorrhea and to investigate the long term safety
- Trial name
- NCT00461305
- Testing
- DRSP 3 mg/EE 20 µg (13 cycles), DRSP 3 mg/EE 30 µg (6 cycles)
- Where
- 26 sites in Japan
- Volunteers
- 420 people
- Sponsor
- Bayer
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)
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