CompletedPhase 3ACTRN12622000103763

The comparison of the effects of piroxicam gel and oral vitamin E in treating cyclic breast pain

The comparison of the therapeutic effects of piroxicam gel and oral vitamin E in cyclic mastalgia

Sponsor

Daniel F Fouladi

Enrollment

70 participants

Start Date

Jan 21, 2020

Study Type

Interventional

Conditions

cyclic mastalgia

Summary

In this study, we compare the effectiveness (in reducing pain) and side effects of two types of routinely used treatments for cyclic breast pain: one treatment with oral vitamin E capsules and the other treatment with topical piroxicam gel.

Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 45 Yearss

Inclusion Criteria1

Patients with cyclic mastalgia of grade 3 or more on visual analogue scale requiring treatment

Exclusion Criteria5

Pregnancy
Concomitant or previous medical condition
Irregular menses
Presence of evidences indicating an underlying etiology for the breast pain by physical examination and/or in imaging studies
Positive allergy to the used medications or placebos

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Interventions

Topical 0.5% piroxicam gel, 4 times daily, liberal amount applied to point of tenderness plus oral placebo capsule containing glucose taken once daily in one group for 2 consecutive months. To moni

Topical 0.5% piroxicam gel, 4 times daily, liberal amount applied to point of tenderness plus oral placebo capsule containing glucose taken once daily in one group for 2 consecutive months. To monitor adherence, patients will be asked to self report weekly.

Locations(3)

Zanjan, Iran, Islamic Republic Of

East Azerbayjan, Iran, Islamic Republic Of

Sistan and Baluchestan, Iran, Islamic Republic Of

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ACTRN12622000103763