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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12622000103763

Enrollment

Registered

2022-01-24

Start date

2020-01-21

Completion date

2020-03-02

Last updated

2022-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 monitor adherence, patients will be asked to self report weekly.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 45 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

-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

Outcome results