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Randomised trial, 1987

Does danazol help premenstrual tension symptoms?

Danazol may help some symptoms better than placebo, particularly breast pain, lethargy, anxiety and increased appetite by the third month. However, 13 of 40 women dropped out during the study, mostly because they felt the treatment was not helping.

Early or limited evidence 40 women with premenstrual tension

What they did

Forty women with premenstrual tension were randomly assigned to receive placebo or 100, 200, or 400 mg danazol daily for 3 months in a double-blind pilot study.

What they found

Thirteen patients withdrew by the third month due to lack of improvement. In danazol-treated women, breast pain, irritability, anxiety and lethargy were significantly lower in months 2-3 compared to placebo. Most placebo symptoms improved in month 1 but only 3 remained improved by month 3. Eight symptoms improved on 200 mg danazol by month 3. More than 75% of women still taking danazol were free of breast pain, lethargy, anxiety and increased appetite. Results for other symptoms were no better than placebo.

What it means for you

Danazol may reduce some premenstrual symptoms better than placebo by the third month. However, a substantial number of women (13 out of 40) did not see improvement and stopped the study, and the benefit was only clear for a few symptoms.

8

Symptoms improved on 200 mg danazol by month 3

>75%

Free of major symptoms on danazol

13

Women who withdrew

About the study

Original title
A clinical trial using danazol for the treatment of premenstrual tension
Authors
Watts JF, Butt WR, Logan Edwards R
Journal
British journal of obstetrics and gynaecology
Year
1987
Study design
Randomised trial
What was tested
Placebo or 100, 200, or 400 mg danazol daily for 3 months

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