Clinical trials: Menstruation Disturbances
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
Amenorrhea, Fertility
A Study to Measure Pharmacokinetic (PK) Concentrations of Gonadotropin-Releasing Hormone Delivered by the OmniPod Pump
One of the Causes of Amenorrhea is hypothalamic amenorrhea, which is a deficiency in the amplitude and/or frequency of endogenous Gonadotropin-releasing hormone (GnRH) Pulses.
- Conditions
- Amenorrhea, Fertility, Infertility
- Trial name
- NCT07152730
- Testing
- Lutrepulse
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Ferring Pharmaceuticals
Leiomyoma, Uterine Fibroids
A Prospective Study Comparing Contour SE™ Microspheres to Embosphere® Microspheres for Treating Symptomatic Uterine Fibroids With Uterine Fibroid Embolization (UFE)
The purpose of this study is to demonstrate comparability between Contour SE™ Microspheres and Embosphere® Microspheres for achieving post UFE fibroid devascularization in women with symptomatic uterine fibroids.
- Conditions
- Leiomyoma, Uterine Fibroids, Uterine Neoplasms, Menorrhagia
- Trial name
- NCT00628901
- Testing
- Uterine Fibroid Embolization (UFE), Contour SE™ Microspheres, Embosphere® Microspheres
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Boston Scientific Corporation
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
Premenstrual Dysphoric Disorder
Intranasal PH80 Spray for Acute Management of the Symptoms of Premenstrual Dysphoric Disorder
The objective of this study is to evaluate the effectiveness and safety in double-blind, randomized, placebo-controlled clinical trials of self administered PH80 intranasal spray for the acute management of cycle related symptoms…
- Trial name
- PH80-PMD (NCT01217775)
- Testing
- PH80
- Where
- United States
- Volunteers
- 1,400 people
- Sponsor
- Pherin Pharmaceuticals, Inc.
Leiomyoma
Assess Safety and Efficacy of Vilaprisan in Patients With Uterine Fibroids
The study is performed to assess the efficacy of Vilaprisan (BAY1002670) in patients with uterine fibroids compared to placebo and ulipristal.
- Trial name
- ASTEROID 2 (NCT02465814)
- Testing
- Vilaprisan (BAY1002670), Vilaprisan (BAY1002670, Ulipristal
- Where
- 64 sites in Austria, Belgium and 14 more
- Volunteers
- 120 people
- Sponsor
- Bayer
Migraine, Migraine Disorders
Menstrual Migraine Treatment With TREXIMET (Formerly Known as TREXIMA)
This study was designed to determine efficacy of TREXIMET (sumatriptan/naproxen sodium), formerly known as TREXIMA compared to placebo for the treatment of a menstrual migraine.
- Trial name
- NCT00329355
- Testing
- sumatriptan succinate/naproxen sodium
- Where
- 35 sites in United States
- Volunteers
- 351 people
- Sponsor
- GlaxoSmithKline
Menorrhagia
Safety & Effectiveness Study of AEGEA Vapor System to Treat Excessive Uterine Bleeding
The purpose of this study is to determine if the AEGEA Vapor System for endometrial ablation is safe and effective for reducing menstrual blood loss in women with excessive uterine bleeding (menorrhagia)
- Trial name
- NCT01979861
- Testing
- AEGEA Vapor System(TM)
- Where
- 15 sites in United States, Canada and 2 more
- Volunteers
- 230 people
- Sponsor
- Aegea Medical, Inc.
Menstrual Pain, Premenstrual Syndrome
An Investigation Into the Efficacy of a Botanical Supplement to Provide Period Relief
Women often experience significant pain during their periods which can significantly impact on quality of life. In this study, two products that are used to alleviate period pain will be examined.
- Trial name
- NCT05845970
- Testing
- Pamprin Botanicals, Pamprin Botanicals + Pamprin Menstrual Pain Relief
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Focus Consumer Healthcare
Heavy Menstrual Bleeding
Transcutaneous Auricular Neurostimulation as a Treatment for Women With Heavy Menstrual Bleeding: A Dose-finding Trial
This study is designed as an open label, single-arm, decentralized research study in which patients with idiopathic heavy menstrual bleeding will receive transcutaneous auricular neurostimulation (tAN), which targets the…
- Trial name
- NCT06814028
- Testing
- Volta System
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Spark Biomedical, Inc.
Menstrual Cycle Disorder, Menstrual Symptoms
Evaluation of The Cycle SyncingⓇ Method: A 12-Week Virtual Clinical Trial
This 12-week, 100% virtual single-group open-label trial evaluates the Cycle SyncingⓇ Method using the MyFLO app, MIRA hormonal monitoring, and continuous glucose monitoring to assess reduction in menstrual cycle symptom burden…
- Conditions
- Menstrual Cycle Disorder, Menstrual Symptoms, Hormonal Imbalance
- Trial name
- NCT07286136
- Testing
- MyFLO App
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- FLO LIVING, LLC
Uterine Fibroids
Post Market TRUST Study
This Post Market study is being conducted to compare the direct and indirect cost of three approaches (GFA, myomectomy, and uterine artery embolization) for the treatment of symptomatic uterine fibroids.
- Trial name
- TRUST (NCT01563783)
- Testing
- Global Fibroid Ablation (GFA), Abdominal or Laparoscopic Myomectomy, Uterine Artery Embolization (UAE)
- Where
- Canada
- Volunteers
- 84 people
- Sponsor
- Acessa Health, Inc.
Heavy Menstrual Bleeding
Juveena Hydrogel System Feasibility Study for Heavy Menstrual Bleeding (HMB)
This is a prospective, multicenter, single-arm interventional feasibility study to evaluate the safety and feasibility of the Juveena Hydrogel System for temporary control of heavy menstrual bleeding (HMB) in women with a history…
- Trial name
- NCT06634719
- Testing
- Juveena Hydrogel System
- Where
- 3 sites in United States
- Volunteers
- 13 people
- Sponsor
- Rejoni Inc.
Contraception, Premenstrual Syndrome
Regulatory Post Marketing Surveillance Study on YAZ
The objective of this Post Marketing Surveillance (PMS) is to gain information about safety and efficacy in real practice.
- Conditions
- Contraception, Premenstrual Syndrome, Acne
- Trial name
- NCT00998257
- Testing
- EE20/DRSP (YAZ, BAY86-5300)
- Where
- South Korea
- Volunteers
- 770 people
- Sponsor
- Bayer
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
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
Menorrhagia, Leiomyoma
Observational Prospective Study on Patients With Symptomatic Uterine Fibroids Treated With VizAblate® Intrauterine-ultrasound Guided RF Ablation
Study is intended to evaluate the one-year safety and clinical status of patients treated for symptomatic uterine fibroids with the VizAblate Intrauterine-ultrasound guided radio frequency (RF) ablation system.
- Conditions
- Menorrhagia, Leiomyoma, Uterine Fibroids, Uterine Fibroma
- Trial name
- NCT01998854
- Testing
- VizAblate System
- Where
- 2 sites in France
- Volunteers
- 4 people
- Sponsor
- Gynesonics
Dysmenorrhea
Pilot Study to Investigate the Effect of a Dysmenorrhoea App
The pilot study investigates the influence of a dysmenorrhoea app on the quality of life and symptoms of women with dysmenorrhoea.
- Trial name
- NCT06283225
- Testing
- Pia-App
- Volunteers
- 100 people
- Sponsor
- Endo Health GmbH
Leiomyoma, Uterine Fibroids
Fibroid Ablation Study - Large Fibroids
The purpose of this study is to establish the effectiveness and confirm the safety of the VizAblate System in the ablation of large (> 5 cm) symptomatic uterine fibroids.
- Conditions
- Leiomyoma, Uterine Fibroids, Menorrhagia
- Trial name
- FAST-L (NCT01539187)
- Testing
- VizAblate System
- Where
- 10 sites in Mexico, Netherlands and 1 more
- Volunteers
- 6 people
- Sponsor
- Gynesonics
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.