Clinical trials: Dysmenorrhea (Disorder)
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 (Disorder), Dysmenorrhea Primary
Mechanistic Characterization of Uterine Pain
There are limited treatment options for management of dysmenorrhea, and the physiological processes they affect are not completely understood.
- Conditions
- Dysmenorrhea (Disorder), Dysmenorrhea Primary, Dysmenorrhea Secondary, Endometrial Diseases
- Trial name
- MCUP (NCT04145518)
- Testing
- Naproxen Sodium
- Where
- United States
- Volunteers
- 183 people, healthy volunteers welcome
- Sponsor
- Endeavor Health
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
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.
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
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.
Cystitis, Interstitial, Dysmenorrhea
Chronic Pain Risk Associated With Menstrual Period Pain
The purpose of this study is to determine if some women with dysmenorrhea (painful periods) are at higher future risk of developing chronic pelvic pain (CPP) and if oral contraceptives (OC) can be used to reverse this chronic…
- Conditions
- Cystitis, Interstitial, Dysmenorrhea, Migraine Disorders, Pelvic Pain
- Trial name
- CRAMPP (NCT02214550)
- Testing
- cyclic microgestin 1/20, continuous microgestin 1/20
- Where
- United States
- Volunteers
- 353 people, healthy volunteers welcome
- Sponsor
- Endeavor Health
Endometriosis
A Global Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain
A randomized study evaluating the safety and efficacy of elagolix in the management of moderate to severe endometriosis-associated pain in adult premenopausal female subjects.
- Trial name
- ELARIS EM-II (NCT01931670)
- Testing
- Elagolix
- Volunteers
- 815 people
- Sponsor
- AbbVie
Endometriosis
Extension to Study on Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain
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
- EDELWEISS 5 (NCT04372121)
- Testing
- 75 mg linzagolix tablet, 200 mg linzagolix tablet, Add-back capsule (E2 1 mg / NETA 0.5 mg)
- Where
- 25 sites in United States, Canada and 1 more
- Volunteers
- 30 people
- Sponsor
- Kissei Pharmaceutical Co., Ltd.
Endometriosis
Ulipristal for Endometriosis-related Pelvic Pain
The aim of this research is to assess the benefit of a medication (ulipristal) for alleviation of symptoms in women with chronic, endometriosis-related pelvic pain.
- Trial name
- NCT02213081
- Testing
- Ulipristal
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Northwestern University
Pain Disorders
Crossover, Single Dose Randomized, Bioequivalence of Ketoprofen Lysine Salt Immediate Release vs Oral Solution
Objectives: The objective of the study was to investigate the bioequivalence between two formulations containing ketoprofen lysine salt (KLS) when administered as single oral doses in two consecutive study periods to healthy male…
- Trial name
- NCT02350296
- Testing
- KSL 40 mg, OKi® 80 mg
- Where
- Switzerland
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Dompé Farmaceutici S.p.A
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.
Endometriosis
A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain
A randomized study evaluating the safety and efficacy of elagolix in the management of moderate to severe endometriosis-associated pain in adult premenopausal female participants.
- Trial name
- ELARIS EM-I (NCT01620528)
- Testing
- elagolix
- Volunteers
- 872 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Endometriosis
SPIRIT EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Endometriosis-Associated Pain
The purpose of this study is to evaluate the long-term efficacy and safety of relugolix 40 milligram (mg) once daily co-administered with low-dose estradiol (E2) and norethindrone acetate (NETA) for up to 104 weeks on…
- Trial name
- NCT03654274
- Testing
- Relugolix, Estradiol/norethindrone acetate
- Where
- 169 sites in United States, Argentina and 18 more
- Volunteers
- 802 people
- Sponsor
- Myovant Sciences GmbH
Endometriosis
Global Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Women 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 adult pre-menopausal women who completed 6 months treatment in pivotal Study…
- Trial name
- NCT02143713
- Testing
- Elagolix
- Volunteers
- 496 people
- Sponsor
- AbbVie
Endometriosis
A Study to Evaluate Safety and Efficacy of Elagolix in Participants With Endometriosis With Associated Moderate to Severe Pain
This is a Phase 3, dose-escalation study designed to evaluate the safety and efficacy of both elagolix alone and elagolix plus estradiol/norethindrone acetate (E2/NETA) over 24 months in the management of endometriosis with…
- Trial name
- NCT03343067
- Testing
- elagolix, estradiol/norethindrone acetate (E2/NETA)
- Where
- 37 sites in United States
- Volunteers
- 11 people
- Sponsor
- AbbVie
Pain, Menstrual, Primary Dysmenorrhea
Music for Pain in Primary Dysmenorrhea
Primary dysmenorrhea is defined as lower abdominal pain that occurs during menses and is not secondary to any type of pelvic disease. It is considered the most common condition in reproductive age women.
- Trial name
- NCT03593850
- Testing
- Music group, Silence Group
- Where
- Colombia
- Volunteers
- 649 people, healthy volunteers welcome
- Sponsor
- Universidad del Rosario