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Randomised trial, 1999

Does danazol given only during the luteal phase help PMS and breast pain?

Danazol was highly effective for premenstrual breast pain but not for general PMS symptoms, with minimal side effects.

Moderate study design 100 women with premenstrual syndrome and premenstrual breast pain

What they did

100 women with PMS and premenstrual breast pain took either 200 mg of danazol or placebo daily during only the luteal phase (second half of the cycle). The study lasted 3 menstrual cycles in a double-blind design.

What they found

Danazol significantly improved breast pain in all 3 months compared to placebo. However, it did not improve other PMS symptoms or overall PMS scores. Side effects were minimal and equal between danazol and placebo groups.

What it means for you

Danazol may be a targeted option for premenstrual breast pain when used only in the luteal phase, which may reduce side effects. It does not help with other PMS symptoms. Longer studies are needed to confirm long-term safety.

100

Women in study

200 mg

Daily dose of danazol

3

Menstrual cycles studied

About the study

Original title
Randomized controlled trial of the management of premenstrual syndrome and premenstrual mastalgia using luteal phase-only danazol
Authors
O'Brien PM, Abukhalil IE
Journal
American journal of obstetrics and gynecology
Year
1999
Study design
Randomised trial
Participants
100
What was tested
Danazol 200 mg daily during luteal phase only or placebo

Topics