Primary dysmenorrhoea Urological and Genital Diseases Dysmenorrhoea
Conditions
Interventions
The subjects will be recruited from female students attending clinical classes in medicine (Faculty of Medicine) or nursing (High Institute of Nursery) at Ain Shams University Maternity Hospital. Sixt
10 cm, severe pain) with values greater than 5 defined as moderate or severe. The Verbal Scale is a 4-point verbal score (on a categorical of: 0, none
1, mild
2, moderate
and 3, severe menstrual pain). Multidimensional scoring system defines the severity of dysmenorrhoea as mild, moderate and severe based on pain, limited activities and medication taken. The presence o
Sponsors
Ain Shams University Maternity Hospital (Egypt)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Female students attending clinical classes in medicine (Faculty of Medicine) or nursing (High Institute of Nursery) at Ain Shams University Maternity Hospital and having moderate or severe spasmodic dysmenorrhoea (history of at least 6 consecutive months of moderate to severe dysmenorrhoea, with the pain starting one day before or on the day of onset of bleeding and lasting at least 1 day during menstruation) and requiring analgesic use for pain relief, in each of the last 3 consecutive cycles preceding admission into the study. 2. Aged 18 - 28 years of age at the time of the study 3. Regular cycles lasting 21 to 35 days with the actual menses periods lasting three to seven days 4. Signed written informed consent by the student to participate in the study
Exclusion criteria
Exclusion criteria: 1. Students who are/were married or planning to get married during the study period 2. Students on hormonal therapy during the last 6 months or those planning to take hormonal therapy including oral contraceptives during the study period 3. Known or suspected secondary dysmenorrhoea (major abdominal or pelvic surgery, endometriosis, pelvic inflammatory disease [PID], ovarian cysts, pathological vaginal secretion, chronic abdominal pain, inflammatory bowel disease, irritable bowel syndrome) 4. History of significant chronic constipation and/or recurrent colitis 5. Serious medical condition: having evidence of clinically relevant gynaecological, cardiovascular, haematologic, hepatic, gastrointestinal (especially active or severe peptic ulceration, or history thereof), renal, pulmonary (especially bronchial asthma or history thereof), endocrinologic, autoimmune diseases, neurologic or psychiatric disease, based on a clinical assessment and routine laboratory investigations 6. Regular intake of medications that are not allowed in the study (pain medications for any other reason including non-steroidal anti-inflammatory drugs [NSAIDs], digoxin, antidepressants, tranquilizers, hypnotics, sedatives, or sex hormones) 7. Any concomitant disease of condition that might require any intake of analgesic medication 8. Unwilling to comply with the protocol 9. Participation in another clinical trial in the last 3 months prior to the start of this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Pain intensity difference at each point (PID-point) and the sum of pain intensity difference at the six designated points (SPID-6) 2. Difference in multidimensional scoring 3. The percentage of patients taking rescue medication 4. Time interval to rescue medication 5. Patient's global evaluation of study medication Measured before taking intake of the medication (0 hour) and after 4, 12, 24, 48 - 60 and 96 - 120 hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| Measures of safety: 1. Adverse events 2. Drug tolerability Measured before taking intake of the medication (0 hour) and after 4, 12, 24, 48 - 60 and 96 - 120 hours. | — |
Countries
Egypt
Outcome results
None listed