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

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ClinicalTrials.gov Identifier: NCT00722800
Recruitment Status : Terminated (Poor recruitment)
First Posted : July 28, 2008
Results First Posted : January 16, 2014
Last Update Posted : February 10, 2014
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Alexandra Kimball, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Hidradenitis Suppurativa
Interventions Drug: drospirenone and ethinyl estradiol (YAZ)
Drug: Placebo
Enrollment 4
Recruitment Details Recruitment methods used were Craig's list, Metro and our hospitals email. All subjects were seen at MGH.
Pre-assignment Details One subject was ineligible because she was taking ibuprofen regularly.
Arm/Group Title Drospirenone and Ethinyl Estradiol (YAZ) Placebo Tablets
Hide Arm/Group Description drospirenone and ethinyl estradiol (YAZ) once a day for 6 months Placebo tablet once a day for 6 months
Period Title: Overall Study
Started 2 2
Completed 0 2
Not Completed 2 0
Reason Not Completed
Withdrawal by Subject             1             0
Physician Decision             1             0
Arm/Group Title Drospirenone and Ethinyl Estradiol (YAZ) Placebo Tablets Total
Hide Arm/Group Description drospirenone and ethinyl estradiol (YAZ) once a day for 6 months Placebo tablet once a day for 6 months Total of all reporting groups
Overall Number of Baseline Participants 2 2 4
Hide Baseline Analysis Population Description
One subject was excluded because she was regularly taking ibuprofen. The other subject changed her mind about study participation.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 2 participants 4 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
 100.0%
2
 100.0%
4
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2 participants 2 participants 4 participants
34  (12.73) 35.5  (14.85) 34.75  (11.33)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 2 participants 4 participants
Female
2
 100.0%
2
 100.0%
4
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants 2 participants 4 participants
2 2 4
1.Primary Outcome
Title Mean Improvement in the Sartorius Severity Score at Month 6.
Hide Description 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.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Drospirenone and Ethinyl Estradiol (YAZ) Placebo Tablets
Hide Arm/Group Description:
drospirenone and ethinyl estradiol (YAZ) once a day for 6 months
Placebo tablet once a day for 6 months
Overall Number of Participants Analyzed 2 2
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.5  (2.1213) 12  (33.9411)
2.Secondary Outcome
Title Change From Baseline in VAS Pain Scale at Month 6.
Hide Description For this pain assessment, the participant indicated the level of average pain experienced over the past 24 hours on a horizontal line, 10 cm in length. A score of 0 indicated "no pain" and a score of 10 indicated "worst pain". The value indicates the change from the baseline participant assessment on the 0 to 10 scale. A negative value indicates a reduction in pain intensity.
Time Frame 6 months from Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Drospirenone and Ethinyl Estradiol (YAZ) Placebo Tablets
Hide Arm/Group Description:
drospirenone and ethinyl estradiol (YAZ) once a day for 6 months
Placebo tablet once a day for 6 months
Overall Number of Participants Analyzed 2 2
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.25  (1.06066) 2  (8.485281)
3.Secondary Outcome
Title Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Month 6.
Hide Description Dermatology Life Quality Index (DLQI) Score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. The DLQI score ranges from 0 (best) to 30 (worst).
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Drospirenone and Ethinyl Estradiol (YAZ) Placebo Tablets
Hide Arm/Group Description:
drospirenone and ethinyl estradiol (YAZ) once a day for 6 months
Placebo tablet once a day for 6 months
Overall Number of Participants Analyzed 2 2
Mean (Standard Deviation)
Unit of Measure: points
3  (1.4142) 8.5  (19.0919)
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Drospirenone and Ethinyl Estradiol (YAZ) Placebo Tablets
Hide Arm/Group Description drospirenone and ethinyl estradiol (YAZ) once a day for 6 months Placebo tablet once a day for 6 months
All-Cause Mortality
Drospirenone and Ethinyl Estradiol (YAZ) Placebo Tablets
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Drospirenone and Ethinyl Estradiol (YAZ) Placebo Tablets
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/2 (0.00%)      0/2 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Drospirenone and Ethinyl Estradiol (YAZ) Placebo Tablets
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/2 (50.00%)      1/2 (50.00%)    
Gastrointestinal disorders     
Nausea   0/2 (0.00%)  0 1/2 (50.00%)  1
Respiratory, thoracic and mediastinal disorders     
Upper respiratory infection   0/2 (0.00%)  0 1/2 (50.00%)  1
Skin and subcutaneous tissue disorders     
fistula with bacterial infection R-axilla   1/2 (50.00%)  1 0/2 (0.00%)  0
Indicates events were collected by systematic assessment
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
Responsible Party: Alexandra Kimball, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00722800     History of Changes
Other Study ID Numbers: 20080p-000843
First Submitted: July 24, 2008
First Posted: July 28, 2008
Results First Submitted: May 6, 2013
Results First Posted: January 16, 2014
Last Update Posted: February 10, 2014