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: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: Bayer
• Treatments: Drospirenone; Drospirenone and ethinyl estradiol combination; Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Ethinyl Estradiol; Polyestradiol phosphate

Criteria

INCLUSION CRITERIA

1. Female Subjects 14-45 years of age who have achieved spontaneous menarche.

2. Clinical diagnosis of hidradenitis suppurativa of stage II or greater on the Hurley scale.

3. Willing and able to understand and sign informed consent.

4. Able to complete study and comply with study procedures.

EXCLUSION CRITERIA

1. Change is use of oral or topical antibiotics in past 90 days.

2. Use of intralesional steroids within 30 days.

3. Use of isotretinoin in past six months.

4. Use of biologics such as Infliximab (Remicade®) or Etanercept (Enbrel®) within the past 3 months or 5 half lives (whichever is shorter).

5. History of renal insufficiency

6. History of hepatic dysfunction

7. History of adrenal Insufficiency

8. History of vascular or metabolic disease including existing or previous arterial thromboembolic diseases (myocardial infarction, stroke), existing or previous venous thromboembolic diseases (deep vein thrombosis, pulmonary embolism), and any condition which could increase the risk to suffer any of the above mentioned disorders

9. History of hypertension

10. History of Diabetes mellitus with vascular involvement

11. Migraine headaches with focal neurological symptoms

12. Major surgery with prolonged immobilization

13. Known or suspected carcinoma of the breast

14. History of Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia

15. Undiagnosed abnormal genital bleeding

16. Cholestatic jaundice of pregnancy or jaundice with prior pill use

17. History of Liver tumor (benign or malignant) or active liver disease

18. Smokers

19. Regular intake of medications that may increase potassium levels such as NSAIDS, potassium sparing diuretics, potassium supplementation, ACE inhibitors, Angiotensin-II receptor antagonists, heparin and aldosterone antagonists.

20. Hypersensitivity to any component of the study drug

21. Clinically significant abnormal findings or conditions (other than acne), which might, in the opinion of the Principal Investigator, interfere with study evaluations or pose a risk to subject safety during the study.

22. Subjects who are known to be pregnant or planning a pregnancy.