A Phase 3 interventional study of YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300) and Placebo in Acne Vulgaris, sponsored by Bayer. Completed at 22 sites in United States. Open to female participants aged 14 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-12-30.
Sponsored by Bayer · Phase 3, Interventional, and Treatment
The objectives of this study were to evaluate the efficacy and safety of drospirenone 3 mg/ethinyl estradiol 0.02 mg (DRSP/EE) in comparison with placebo in female subjects with moderate acne vulgaris during 6 treatment cycles
730 studies on the registry are indexed under Acne Vulgaris; 86 are open to participants now.
This study's enrollment of 541 is above the median of 69 across 628 interventional studies indexed under Acne Vulgaris.
Browse Acne Vulgaris studies →Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300)
Drug: Placebo
The study medication was packaged in 28-tablet blister packs. Each subject kit contained 6 blister packs plus 1 reserve blister pack.Subjects randomly assigned to the active treatment group received 24 consecutive days of hormonally active tablets (3mgDRSP/0.02mgEE) followed by 4 consecutive days of inactive tablets. The treatment period was 6 cycles (28 tablets per cycle).
The subjects randomly assigned to the placebo group received 28 inert but identical-appearing, color-matched tablets. The treatment period was 6 cycles (28 tablets per cycle)
Percent change in inflammatory lesion counts (including papules, pustules, and nodules), non-inflammatory lesion counts (including open and closed comedones), total lesion count, and the ISGA.
Time frame: From baseline to Cycle 6.
Change from baseline in count of papules
Time frame: Visits 3-5
Change from baseline in count of pustules
Time frame: Visits 3-5
Change from baseline in count of nodules
Time frame: Visits 3-5
Change from baseline in count of open comedones
Time frame: Visits 3-5
Change from baseline in count of closed comedones
Time frame: Visits 3-5
Percentage of subjects classified as "improved" according to the Investigator's Overall Improvement Rating
Time frame: Visits 3-5
Percentage of subjects classifying themselves as "improved" on the Subject's Overall Self-Assessment Rating
Time frame: Visits 3-5
This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.
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