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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03323671
Other study ID # 27011975
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received October 27, 2015
Last updated December 17, 2017
Start date August 1, 2017
Est. completion date December 1, 2017

Study information

Verified date December 2017
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Preemptive analgesia before the release of pain mediators


Description:

spasmodic dysmenorrhea is one of the most distressing symptoms in women. adolescents shows a usual absence from school . prostaglandin release is one of the most accepted theory responsible for spasmodic dysmenorrhea.

Non steroidal anti inflammatory Drugs were proved to be one of the alternative medications for spasmodic dysmenorrhea.

Getting the idea of what is called preemptive anesthesia by blocking the receptors before catching pain mediators the study participants will be divided randomly into 2 group group 1 receiving ttt 2 days before the anticipated menstruation and group 2 receiving ttt only during menstruation as analgesia


Recruitment information / eligibility

Status Completed
Enrollment 84
Est. completion date December 1, 2017
Est. primary completion date December 1, 2017
Accepts healthy volunteers No
Gender Female
Age group 15 Years to 25 Years
Eligibility Inclusion Criteria:

- nulliparous ladies

- with regular menstrual cycle pattern

- those experienced history of dysmenorrhea (primary or spasmodic)

- patients able to sallow tables

Exclusion Criteria:

- irregular cycles

- any associated local causes( pelvic infection, endometriosis, fibroid or others)

- patients with familial Mediterranean fever or other intermenstrual attacks of abdominal pain

- gastric or duodenal ulcers or gastritis

- other contraindications to non steroidal anti-inflammatory drugs

- patients with severe diminution of vision or color discrimination

- patients with any depressive or mood disorders

- patients receiving any hormonal treatment

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
preemptive mefenamic acid
preemptive analgesia before menstrual pain
mefenamic acid
mefenamic acid given only during menstruation

Locations

Country Name City State
Egypt Mansoura University Mansourah

Sponsors (1)

Lead Sponsor Collaborator
Hanan Nabil

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary change in the Degree of pain severity of pain according to visual pain analog scale 4 months
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