A Study to Examine the Safety and Efficacy of Drospirenone and Ethinyl Estradiol (YAZ) Versus Placebo In HS
Status:
Terminated
Trial end date:
2011-12-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to find out if taking a birth control pill, YAZ, is safe and
effective for treating hidradenitis suppurativa. Hidradenitis suppurativa (HS) is a chronic
(long lasting) skin disorder that mostly affects the armpits and groin area. It appears as
blackheads and one or more red, tender bumps that may enlarge, break open, and drain pus.
Scarring may result after several attacks of the disease.
The exact cause of HS isn't known. However, it is believed that the plugging of hair
follicles and bacterial infection that occur in acne also occur in HS. Many of the
medications used for treating acne are also used for HS. However, none of the medications are
consistently effective.
YAZ is a combination birth control pill. Nearly all birth control pills are made up of a
combination of estrogen and progestin hormones. YAZ contains ethinyl estradiol (an estrogen)
and drospirenone (a progestin). People who develop acne have sebaceous glands that are
over-stimulated by male sex hormones (androgens). Sebaceous glands secrete an oily substance
into a hair follicle to lubricate hair or skin. The progestin in YAZ actually blocks the male
sex hormones (androgens) that cause acne. Hormones seem to play a role in HS as the condition
occurs after puberty. It affects more women than men and HS often gets worse around the time
a women has her menstrual period.
YAZ has been approved by the U.S. Food and Drug Administration (FDA) to treat moderate acne
in women who desire an oral contraceptive for birth control.
This study uses a placebo. A placebo looks like the study drug but contains no active drug.
We use placebos in research studies to learn if the effects seen in research subjects are
truly from the study drug or from other reasons.