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

This study has been terminated.
(Poor recruitment)
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Alexandra Kimball, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00722800
First received: July 24, 2008
Last updated: January 16, 2014
Last verified: January 2014
Results First Received: May 6, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Hidradenitis Suppurativa
Interventions: Drug: drospirenone and ethinyl estradiol (YAZ)
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment methods used were Craig's list, Metro and our hospitals email. All subjects were seen at MGH.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One subject was ineligible because she was taking ibuprofen regularly.

Reporting Groups
  Description
Drospirenone and Ethinyl Estradiol (YAZ) drospirenone and ethinyl estradiol (YAZ) once a day for 6 months
Placebo Tablets Placebo tablet once a day for 6 months

Participant Flow:   Overall Study
    Drospirenone and Ethinyl Estradiol (YAZ)     Placebo Tablets  
STARTED     2     2  
COMPLETED     0     2  
NOT COMPLETED     2     0  
Withdrawal by Subject                 1                 0  
Physician Decision                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
One subject was excluded because she was regularly taking ibuprofen. The other subject changed her mind about study participation.

Reporting Groups
  Description
Drospirenone and Ethinyl Estradiol (YAZ) drospirenone and ethinyl estradiol (YAZ) once a day for 6 months
Placebo Tablets Placebo tablet once a day for 6 months
Total Total of all reporting groups

Baseline Measures
    Drospirenone and Ethinyl Estradiol (YAZ)     Placebo Tablets     Total  
Number of Participants  
[units: participants]
  2     2     4  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     2     2     4  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  34  ± 12.73     35.5  ± 14.85     34.75  ± 11.33  
Gender  
[units: participants]
     
Female     2     2     4  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     2     2     4  



  Outcome Measures
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1.  Primary:   Mean Improvement in the Sartorius Severity Score at Month 6.   [ Time Frame: 6 months ]

2.  Secondary:   Change From Baseline in VAS Pain Scale at Month 6.   [ Time Frame: 6 months from Baseline ]

3.  Secondary:   Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Month 6.   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Very small sample size.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Alexandra B. Kimball, MD
Organization: MGH
phone: 617-726-5066
e-mail: harvardskinstudies@partners.org


No publications provided


Responsible Party: Alexandra Kimball, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00722800     History of Changes
Other Study ID Numbers: 20080p-000843
Study First Received: July 24, 2008
Results First Received: May 6, 2013
Last Updated: January 16, 2014
Health Authority: United States: Institutional Review Board