Clinical trials: Menstrual Cycle Disorder
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
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
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
Leiomyoma, Menorrhagia
Study to Evaluate the Safety of Asoprisnil in the Treatment of Uterine Fibroids
The objective of this study is to determine the long-term safety of asoprisnil in women with abnormal uterine bleeding associated with uterine fibroids.
- Conditions
- Leiomyoma, Menorrhagia, Metrorrhagia
- Trial name
- NCT00156195
- Testing
- Asoprisnil
- Volunteers
- 523 people
- Sponsor
- Abbott
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
Contraception
KYleena Satisfaction Study / Observational Study on User Satisfaction With the Levonorgestrel Intrauterine Delivery System Kyleena (LNG-IUS 12) in New Contraceptive Users and After Switching From Another Contraceptive Method
The main goal of this non-interventional study (NIS) is to evaluate user satisfaction with Kyleena in a real-life setting and to identify factors which influence user satisfaction, taking into account previously used…
- Trial name
- KYSS (NCT03182140)
- Testing
- Kyleena
- Where
- 19 sites in United States, Belgium and 6 more
- Volunteers
- 1,134 people, healthy volunteers welcome
- Sponsor
- Bayer
Dysmenorrhea
The Impact of Oral Probiotics on Improving the Quality of Life in Patients With Dysmenorrhea.
Menstrual pain is mainly divided into primary dysmenorrhea and secondary dysmenorrhea, the former is caused by menstrual uterine muscle movement; the latter is caused by certain diseases, such as Endometriosis, Uterine fibroids…
- Trial name
- NCT07530081
- Testing
- High dose Probiotic, Low dose probiotic
- Where
- Taiwan
- Volunteers
- 150 people
- Sponsor
- Glac Biotech Co., Ltd
Premenopause, Iron-deficiency
A Clinical Study on Adherence and Efficacy of Different Doses of Active Iron in Treatment Resistant Subjects
A randomized, placebo controlled, parallel group, double blind study to compare the 3-month adherence and efficacy of Active Iron in subjects with or at-risk of iron deficiency and a history of intolerance to oral iron.
- Conditions
- Premenopause, Iron-deficiency, Iron Adverse Reaction, Iron Deficiency Anemia
- Trial name
- NCT04778072
- Testing
- Ferrous sulfate 14mg once daily, Ferrous sulfate 25mg once daily, Ferrous sulfate 25mg twice daily
- Where
- Ireland
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Solvotrin Innovations Ltd
Menstrual Pain
Effectiveness of PEA Compared to Placebo on Acute Menstrual Pain
This is a double blind, randomised, placebo-controlled trial to evaluate orally-dosed Palmitoylethanolamide (PEA) compared to placebo on menstrual pain in otherwise healthy participants 18 years and over.
- Trial name
- NCT05810116
- Testing
- Levagen+, Microcrystalline cellulose
- Where
- Australia
- Volunteers
- 80 people
- Sponsor
- RDC Clinical Pty Ltd
Dysmenorrhea
YAZ Post-marketing Surveillance in Japan
This study is a regulatory post marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received YAZ for dysmenorrhea.
- Trial name
- NCT01375998
- Testing
- EE20/DRSP(YAZ, BAY86-5300)
- Where
- Japan
- Volunteers
- 3,273 people
- Sponsor
- Bayer
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
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
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.
PMS, Menstrual Discomfort
Study to Evaluate Your Super's Moon Balance and Its Impact on Premenstrual Syndrome
This is an open-label observational single-group clinical trial to study the efficacy of a commercially available dietary supplement and its effect on common PMS and menstrual symptoms, as well as health-related biomarkers.
- Conditions
- PMS, Menstrual Discomfort, Menstrual Pain
- Trial name
- NCT05237661
- Testing
- Moon Balance
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Your Super, INC.
Endometriosis, Pelvic Pain
Efficacy of Manual Therapy to Improve Quality of Life and Decrease Pain in Subjects With Endometriosis
This study will compare subjects with a history of pelvic or menstrual pain diagnosed with endometriosis treated at Clear Passage with untreated control subjects.
- Conditions
- Endometriosis, Pelvic Pain, Dysmenorrhea
- Trial name
- Endo2017 (NCT03118154)
- Testing
- Manual Physical Therapy
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Clear Passage Therapies, Inc
Dysmenorrhea
Efficacy and Safety Study of Lidocaine Vaginal Gel for Recurrent Dysmenorrhea (Painful Periods)
The purpose of this study is to determine whether lidocaine vaginal gel is safe and effective for preventing or reducing the severity of dysmenorrhea (painful menstrual periods) compared to placebo (inactive gel).
- Trial name
- Lidocaine 04 (NCT00651313)
- Testing
- Lidocaine
- Where
- 4 sites in United States
- Volunteers
- 81 people, healthy volunteers welcome
- Sponsor
- Juniper Pharmaceuticals, 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
PMS, Menstrual Cramp
A Randomized Placebo-Controlled Study to Evaluate the Effects of a Gummy and Capsule Supplement on Symptoms of Premenstrual Syndrome
This virtual, randomized, placebo-controlled clinical trial evaluates the effectiveness of a PMS capsule and PMS gummy in alleviating premenstrual syndrome symptoms over 12 weeks.
- Conditions
- PMS, Menstrual Cramp, Mood Change
- Trial name
- NCT06763809
- Testing
- PMS Capsule, PMS Gummy
- Where
- United States
- Volunteers
- 176 people, healthy volunteers welcome
- Sponsor
- Semaine Health
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
Premenstrual Syndrome (PMS)
Oxaloacetate Supplementation for Emotional PMS
Emotional Premenstrual Syndrome (PMS) affects millions of women worldwide. For Emotional PMS, including depression, anxiety, perceived stress and aggression, there are very few options.
- Trial name
- OAA4PMS (NCT03509714)
- Testing
- Jubilance (100 mg Oxaloacetate/150 mg Ascorbic Acid)
- Volunteers
- 48 people
- Sponsor
- Terra Biological LLC