Clinical trials: Menstrual Symptoms
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
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
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
Polycystic Ovary Syndrome, Menstrual Problem
Myoinositol Plus L-tyrosine, Selenium and Chromium in PCOS
PCOS patients were treated every day, with one sachet containing 2000 mg myo-inositol, 500 mg L-tyrosine, 40 mcg chromium picolinate, 55 mcg selenium, 200 mcg folic acid.
- Conditions
- Polycystic Ovary Syndrome, Menstrual Problem, Hirsutism
- Trial name
- NCT03673995
- Testing
- Myo-inositol+L-tyrosine
- Where
- Italy
- Volunteers
- 186 people
- Sponsor
- Pharmarte srl
Premenstrual Syndrome
Evaluation of Safety/Efficacy of Diagnostic Skin Test Panel and Desensitization Hormone Kit for Treatment of Premenstrual Syndrome (PMS)
The EVE-PMS technology is intended for determination of intolerance or sensitivity to sex hormones, among women suffering from severe PreMenstrual Syndrome (PMS) and desensitizes them with the relevant sex hormones in order to…
- Trial name
- NCT00873262
- Testing
- Skin test panel and desensitization kit, Skin test panel and solvent
- Where
- Israel
- Volunteers
- 20 people
- Sponsor
- EVE Medical Systems Ltd.
Heavy Menstrual Bleeding
IUB SEAD RED (Revolutionary Endometrial Ablation Device Study
One of the AUB symptoms, heavy menstrual bleeding (HMB), can lead to iron deficiency and iron deficiency anemia and in acute and severe cases, can necessitate emergency medical care.
- Trial name
- HMB (NCT04959396)
- Testing
- IUB SEAD
- Where
- 9 sites in Georgia, Israel
- Volunteers
- 30 people
- Sponsor
- Ocon Medical Ltd.
Leiomyoma, Uterine Fibroids
Safety and Effectiveness Study of RF Ablation of Uterine Fibroids to Reduce Menstrual Bleeding: the Fibroid Ablation Study
The primary objective of this study is to test the hypothesis that a minimum 75% volume radiofrequency ablation of fibroids associated with menorrhagia results in reduction of menstrual bleeding.
- Conditions
- Leiomyoma, Uterine Fibroids, Menorrhagia
- Trial name
- FAST (NCT00768742)
- Testing
- VizAblate Intrauterine Ultrasound-Guided RF Ablation
- Where
- 3 sites in Canada
- Sponsor
- Gynesonics
Premenstrual Dysphoric Disorder
A Phase I/II Study to Evaluate UC1010 Treatment in Premenstrual Dysphoric Disorder (PMDD)
The study is a phase 1/2 study in two parts. In part 1, the primary objective is to assess the pharmacokinetics of UC1010 when administered subcutaneously as a single dose to healthy women.
- Trial name
- NCT01875718
- Testing
- UC1010
- Where
- Sweden
- Volunteers
- 146 people
- Sponsor
- Umecrine Mood AB
Heavy Menstrual Bleeding, Uterine Fibroids
A Study to Assess Patient-Reported Quality of Life and Effectiveness on Control of Bleeding in Adult Participants With Heavy Menstrual Bleeding Due to Uterine Fibroids Taking Oral Oriahnn Capsules
Uterine Fibroids (UF) are noncancerous (benign) tumors that commonly occur in up to 80% of women of reproductive age. Symptoms can include heavy menstrual bleeding (HMB), low back pain, urinary frequency and urgency…
- Trial name
- REACH (NCT05026502)
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- AbbVie
Premenstrual Syndrome, Premenstrual Dysphoric Disorder
CREST: Samphire Guided Care Program on Wellbeing, Work Productivity, and Quality of Life
This study evaluates the feasibility and efficacy of the Samphire Guided Care (SGC) program a 12-week structured digital health program combining clinician-led onboarding, at-home neuromodulation using the Lutea tDCS device…
- Conditions
- Premenstrual Syndrome, Premenstrual Dysphoric Disorder, Dysmenorrhea, Endometriosis
- Trial name
- CREST (NCT07679074)
- Testing
- Lutea Transcranial Direct Current Stimulation (tDCS) Device, Samphire Guided Care Program
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Samphire Group, Inc.
Menorrhagia, Uterine Fibroids
Doppler-Guided Uterine Artery Occlusion (DUAO) Device for Fibroid Related Bleeding
The objective of this study is to evaluate the safety and effectiveness of Doppler guided uterine artery occlusion (D-UAO) for the reduction of fibroid associated bleeding.
- Trial name
- DUAO (NCT00496080)
- Testing
- Doppler-Guided Uterine Artery Occlusion Device (DUAO)
- Where
- 11 sites in United States, Canada and 1 more
- Volunteers
- 87 people
- Sponsor
- Ethicon, Inc.
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
Amenorrhea
A Trial to Evaluate DR-2021 in Women With Secondary Amenorrhea
This is a multicenter trial to compare the effectiveness of 4 doses of DR-2021 with placebo and oral micronized progesterone in inducing withdrawal bleeding in women with secondary amenorrhea.
- Trial name
- NCT00196391
- Testing
- DR-2021a, DR-2021b, DR-2021c
- Where
- 27 sites in United States
- Volunteers
- 180 people
- Sponsor
- Duramed Research
Menorrhagia
Lysteda Pediatric Research Equity Act (PREA) Pharmacokinetic Study in Adolescent Females With Heavy Menstrual Bleeding
This is a Phase 4, randomized, 2-way crossover, pharmacokinetic study of Lysteda (tranexamic acid) tablets administered as single doses of 0.65 g and 1.3 g in fasting adolescent female subjects ages 12-16 years with heavy…
- Trial name
- PREA (NCT01190150)
- Testing
- tranexamic acid
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Ferring Pharmaceuticals
Endometriosis
A Long-Term Study to Evaluate the Safety of Asoprisnil in the Treatment of Women With Endometriosis From Study M01-398
The objective of this study is to determine the long-term safety of asoprisnil 5 mg for 12 months in women with endometriosis from study M01-398.
- Trial name
- NCT00160420
- Testing
- Asoprisnil
- Volunteers
- 73 people
- Sponsor
- Abbott
Menorrhagia
A Clinical Study of the Aqua Therapeutics Thermal Therapy Vapor Ablation System in Premenopausal Women With Abnormal Uterine Bleeding
Abnormal uterine bleeding (AUB) is defined as "flow outside of normal volume, duration, regularity, or frequency". Acute AUB is excessive bleeding that requires immediate intervention to prevent further blood loss.
- Trial name
- AQTH-EA-PIV-24 (NCT07877051)
- Testing
- Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS)
- Where
- 3 sites in Georgia
- Volunteers
- 43 people
- Sponsor
- Aqua Therapeutics, 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
Symptomatic Uterine Fibroids
Post Market TRUST - U.S.A. 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
- NCT02163525
- Testing
- Global Fibroid Ablation (GFA), Abdominal or Laparoscopic Myomectomy, Uterine Artery Embolization (UAE)
- Where
- 9 sites in United States
- Volunteers
- 114 people
- Sponsor
- Acessa Health, Inc.
Menstrual Migraine (MM) Headaches
Effectiveness And Safety Of Frovatriptan For The Management (Acute Treatment) Of Menstrual Migraine
Females 18 years of age or older with at least one year history of menstrual migraine (MM) headaches participated in a Phase 4 clinical trial to evaluate the efficacy of frovatriptan when used at the early stage (International…
- Trial name
- NCT00904098
- Testing
- Frovatriptan, Usual Care
- Where
- 21 sites in United States
- Volunteers
- 192 people
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
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)