A Study to Examine the Safety and Efficacy of Drospirenone and Ethinyl Estradiol (YAZ) Versus Placebo In HS

NCT00722800 | Terminated Phase 2 Results

• 1 other identifier: 20080p-000843
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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) 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.

Conditions

Hidradenitis Suppurativa

Keywords

YAZ; oral contraceptive; hidradenitis suppurativa

Outcome Measures

Primary Outcomes (1)

• Mean Improvement in the Sartorius Severity Score at Month 6.

  The Sartorius Severity score reflects changes in hidradenitis suppurative symptoms, namely the number of lesions (abscesses, nodules, and fistulas) and the longest distance between lesions. A total score is derived based on assessments at up to 8 distinct anatomical regions and ranges from 5 to indefinite. Smaller numbers are better scores and indicate less lesion involvement, thus decreases (negative changes) from baseline indicate improvement in severity of disease.

  6 months

Secondary Outcomes (2)

• Change From Baseline in VAS Pain Scale at Month 6.

  6 months from Baseline

• Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Month 6.

  6 months

Study Arms (2)

A

EXPERIMENTAL

drospirenone and ethinyl estradiol

Drug: drospirenone and ethinyl estradiol (YAZ)

B

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

drospirenone and ethinyl estradiol (YAZ) DRUG

1 tablet daily for 24 weeks

A

Placebo DRUG

1 tablet daily for 24 weeks

B

Eligibility Criteria

• Age: 14 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Bayer: collaborator

Study Sites (1)

Clinical Unit for Research Trials in Skin

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

drospirenone; Ethinyl Estradiol; drospirenone and ethinyl estradiol combination

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Intervention Hierarchy (Ancestors)

Norpregnatrienes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Limitations and Caveats

Very small sample size.

Results Point of Contact

• Title: Alexandra B. Kimball, MD
• Organization: MGH

harvardskinstudies@partners.org

617-726-5066

Study Officials

• Alexandra B Kimball, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 24, 2008
• First Posted: July 28, 2008
• Study Start: October 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: February 10, 2014
• Results First Posted: January 16, 2014

Record last verified: 2014-01

Locations

US (1)