Status:
TERMINATED
A Study to Examine the Safety and Efficacy of Drospirenone and Ethinyl Estradiol (YAZ) Versus Placebo In HS
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Bayer
Conditions:
Hidradenitis Suppurativa
Eligibility:
FEMALE
14-45 years
Phase:
PHASE2
Brief 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) ski...
Detailed Description
Hidradenitis suppurativa is a chronic suppurative and scarring disease primarily affecting the axillae and inguinal and perineal areas. The apocrine glands are the primary targets. It is characterized...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- Female Subjects 14-45 years of age who have achieved spontaneous menarche.
- Clinical diagnosis of hidradenitis suppurativa of stage II or greater on the Hurley scale.
- Willing and able to understand and sign informed consent.
- Able to complete study and comply with study procedures.
- EXCLUSION CRITERIA
- Change is use of oral or topical antibiotics in past 90 days.
- Use of intralesional steroids within 30 days.
- Use of isotretinoin in past six months.
- Use of biologics such as Infliximab (Remicade®) or Etanercept (Enbrel®) within the past 3 months or 5 half lives (whichever is shorter).
- History of renal insufficiency
- History of hepatic dysfunction
- History of adrenal Insufficiency
- 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
- History of hypertension
- History of Diabetes mellitus with vascular involvement
- Migraine headaches with focal neurological symptoms
- Major surgery with prolonged immobilization
- Known or suspected carcinoma of the breast
- History of Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia
- Undiagnosed abnormal genital bleeding
- Cholestatic jaundice of pregnancy or jaundice with prior pill use
- History of Liver tumor (benign or malignant) or active liver disease
- Smokers
- 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.
- Hypersensitivity to any component of the study drug
- 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.
- Subjects who are known to be pregnant or planning a pregnancy.
Exclusion
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00722800
Start Date
October 1 2008
End Date
December 1 2011
Last Update
February 10 2014
Active Locations (1)
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1
Clinical Unit for Research Trials in Skin
Boston, Massachusetts, United States, 02114