Evaluate Safety and Efficacy of an Oral Contraceptive (OC) Preparation Versus Placebo for 6 Treatment Cycles in Women With Moderate Acne
NCT ID: NCT00656981
Last Updated: 2014-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
541 participants
INTERVENTIONAL
2003-01-31
2004-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm 1
YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300)
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).
Arm 2
Placebo
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)
Interventions
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YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300)
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).
Placebo
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)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Subjects with acne and atopia, comedonal acne or acne conglobate, sandpaper acne or acne with multiple large nodes, cysts, fistular comedones, or abscessing fistular ducts
* Use of comedogenic covering cream, comedogenic sunscreens, other sex hormone preparations or any other anti-acne therapy (eg, light therapy, oleic acids, chemical peelings, mechanical extraction of comedones)
* Acne therapy with sex hormone preparations given over 3 months or longer and proved to be unsuccessful
* Preparations that have had an acne-inducing effect, eg, iodinated or bromated drugs, tuberculostatics, lithium, Vitamin B1, B6, B12, D3, corticoids, ACTH, anabolics, quinine, disulfiram, methoxypsoralen, phenobarbital, phenytoin, trimethadione, thyroid depressants, and certain oily cosmetics
14 Years
45 Years
FEMALE
Yes
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Mobile, Alabama, United States
Kingman, Arizona, United States
Encino, California, United States
San Diego, California, United States
San Diego, California, United States
Westlake Village, California, United States
Castle Rock, Colorado, United States
Denver, Colorado, United States
Palm Springs, Florida, United States
St. Petersburg, Florida, United States
Venice, Florida, United States
Boise, Idaho, United States
Shawnee, Kansas, United States
Louisville, Kentucky, United States
Fridley, Minnesota, United States
East Steauket, New York, United States
New York, New York, United States
Medford, Oregon, United States
Portland, Oregon, United States
Byran, Texas, United States
Arlington, Virginia, United States
Seattle, Washington, United States
Countries
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Other Identifiers
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306996
Identifier Type: -
Identifier Source: secondary_id
91231
Identifier Type: -
Identifier Source: org_study_id