A double-blind, randomized, cross-over, multi-center efficacy and safety study of ibuprofen plus hyoscine butylbromide for pain management due to primary dysmenorrhea
- Conditions
- The efficacy and safety of ibuprofen plus hyoscine butylbromide for pain management due to primary dysmenorrhea will be investigated. Primary dysmenorrhea is the most common gynecological complaint in reproductive women. It is characterized by painful uterine contraction or menstrual cramps, occurring during menstruation without pelvic pathologies. Pain usually occurs intensely on the first or second day or the first 24–36 hours of menstruation.Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
- Registration Number
- EUCTR2022-000843-57-BG
- Lead Sponsor
- RONTIS HELLAS S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 54
[1]Female patients =18 and =40 years of age
[2]Patients with a history of primary dysmenorrhea
[3]Patients with moderate to severe pain in at least 5 of the last 6 menstrual cycles
[4]Patients willing and able (e.g., mental and physical condition) to participate in all aspects of the study as evidenced by providing signed written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 54
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
[1]History of hypersensitivity or intolerance to the active substances or any of the excipients of the study medication
[2]History of hypersensitivity reactions (e.g., asthma, urticaria, angioedema or rhinitis) after taking other NSAIDs (e.g., acetylsalicylic acid or similar)
[3]Any condition which might cause secondary dysmenorrhoea (e.g., endometriosis, salpingitis, adhesions)
[4]Other likely causes of abdominal pain (e.g., gastric or peptic ulcer, inflammatory bowel disease, leiomyoma, pelvic inflammatory disease)
[5]History of gastrointestinal bleeding
[6]Conditions involving an increased tendency to bleeding
[7]History of frequent dyspepsia, heartburn or indigestion
[8]Severe heart failure (NYHA Class IV), hepatic failure and renal failure
[9]Any of the following conditions:
a)untreated narrow angle glaucoma,
b)gastric outlet obstruction,
c)intestinal atony,
d)tachycardia,
e)mechanical stenosis of the gastrointestinal tract, myasthenia gravis,
f)megacolon
[10]History of significant disease deemed by the investigator to render the patients unsuitable for inclusion
[11]Concomitant major depression
[12]Concomitant condition that may interfere with the absorption, distribution, metabolism, or excretion of the study medication
[13]Previous (within 7 days before first study drug administration) intake or administration of analgesic, anti-inflammatory, antispasmodic or other therapy for dysmenorrhoea
[14]Previous (within 7 days before first study drug administration) intake or administration of medications that might confound the assessment of pain relief, such as psychotropic drugs, antidepressants, sedative-hypnotics, NSAIDs, muscle relaxants*
[15]Intake of oral contraceptives during the last 2 menstrual cycles preceding the trial
[16]Administration of hormonal contraceptive devices during the last 2 menstrual cycles preceding the trial
[17]Administration of long-acting depot contraceptives within the last 6 months preceding the trial
[18]Patient is currently enrolled in, or has completed less than 30 days before the screening examination of the present trial another clinical trial with an investigational drug
[19]Previous enrolment in this study
[20]Pregnant or breast-feeding women
[21]Women of childbearing potential unable or unwilling to undergo pregnancy tests and to practice adequate contraceptive measures. Reliable methods for women during the trial are:
a)combination of 2 barrier methods: female/male condoms, diaphragms, spermicides
b)surgical intervention (e.g., tubal ligation),
c)non-hormonal intrauterine device (IUD)
d)sexual abstinence
[22]Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the study
[23]Alcohol/drug dependence or abuse (excluding tobacco abuse)
[24]Unreliability or lack of cooperation
[25]Any other condition of the patient (e.g., serious or unstable medical or psychological condition, acute psychosis) that in the opinion of the investigator may compromise evaluation of the study treatment or may jeopardize patient’s safety, compliance or adherence to protocol requirements
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method