NCT00651469

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
534

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2003

Geographic Reach
1 country

27 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2004

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 2, 2008

Completed
Last Updated

December 30, 2014

Status Verified

December 1, 2014

First QC Date

March 31, 2008

Last Update Submit

December 29, 2014

Conditions

Acne Vulgaris

Keywords

Moderate Acne VulgarisAcne

Outcome Measures

Primary Outcomes (1)

  • 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.

    From baseline to Cycle 6

Secondary Outcomes (7)

  • Change from baseline in count of papules

    Visits 3-5

  • Change from baseline in count of pustules

    Visits 3-5

  • Change from baseline in count of nodules

    Visits 3-5

  • Change from baseline in count of open comedones

    Visits 3-5

  • Change from baseline in count of closed comedones

    Visits 3-5

  • +2 more secondary outcomes

Study Arms (2)

Arm 1

EXPERIMENTAL
Drug: YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300)

Arm 2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300)DRUG

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 1
PlaceboDRUG

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)

Arm 2

Eligibility Criteria

Age14 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Female age 14-45, with 10 to 100 comedones (noninflammatory lesions), 10 to 50 inflammatory lesions (papules or pustules), and not more than 35 nodules (\<5mm) on the face).

You may not qualify if:

  • Standard contraindications for use of combined oral contraceptives (class label) plus
  • 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 pellings, 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (27)

Unknown Facility

Birmingham, Alabama, 35209, United States

Location

Unknown Facility

Huntsville, Alabama, 35801, United States

Location

Unknown Facility

Mesa, Arizona, 85201, United States

Location

Unknown Facility

Los Angeles, California, 90010, United States

Location

Unknown Facility

San Diego, California, 92108, United States

Location

Unknown Facility

Washington D.C., District of Columbia, 20010-2975, United States

Location

Unknown Facility

Miami, Florida, 33175, United States

Location

Unknown Facility

St. Petersburg, Florida, 33702, United States

Location

Unknown Facility

Tampa, Florida, 33607, United States

Location

Unknown Facility

Boise, Idaho, 83704, United States

Location

Unknown Facility

Chicago, Illinois, 60631, United States

Location

Unknown Facility

Indianapolis, Indiana, 46250, United States

Location

Unknown Facility

New Orleans, Louisiana, 70115, United States

Location

Unknown Facility

Wellesley, Massachusetts, 02481, United States

Location

Unknown Facility

Kansas City, Missouri, 64114, United States

Location

Unknown Facility

Albuquerque, New Mexico, 87106, United States

Location

Unknown Facility

Winston-Salem, North Carolina, 27103, United States

Location

Unknown Facility

Winston-Salem, North Carolina, 27157, United States

Location

Unknown Facility

Cincinnati, Ohio, 45230, United States

Location

Unknown Facility

Hershey, Pennsylvania, 17033-0850, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, 19114, United States

Location

Unknown Facility

Warwick, Rhode Island, 02886, United States

Location

Unknown Facility

Austin, Texas, 78759, United States

Location

Unknown Facility

Dallas, Texas, 75230, United States

Location

Unknown Facility

Houston, Texas, 77024, United States

Location

Unknown Facility

San Antonio, Texas, 78229, United States

Location

Unknown Facility

Tacoma, Washington, 98405, United States

Location

Related Publications (2)

  • Koltun W, Maloney JM, Marr J, Kunz M. Treatment of moderate acne vulgaris using a combined oral contraceptive containing ethinylestradiol 20 mug plus drospirenone 3mg administered in a 24/4 regimen: a pooled analysis. Eur J Obstet Gynecol Reprod Biol. 2011 Apr;155(2):171-5. doi: 10.1016/j.ejogrb.2010.12.027. Epub 2011 Feb 2.

    PMID: 21288628RESULT

  • Maloney JM, Dietze P Jr, Watson D, Niknian M, Lee-Rugh S, Sampson-Landers C, Korner P. Treatment of acne using a 3-milligram drospirenone/20-microgram ethinyl estradiol oral contraceptive administered in a 24/4 regimen: a randomized controlled trial. Obstet Gynecol. 2008 Oct;112(4):773-81. doi: 10.1097/AOG.0b013e318187e1c5.

    PMID: 18827119DERIVED

MeSH Terms

Conditions

Acne Vulgaris

Interventions

drospirenone and ethinyl estradiol combinationdrospirenone

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR
Expanded Access
Yes

Study Record Dates

First Submitted

March 31, 2008

First Posted

April 2, 2008

Study Start

January 1, 2003

Study Completion

July 1, 2004

Last Updated

December 30, 2014

Record last verified: 2014-12

Locations

US(27)