GA YAZ ACNE in China Phase III

NCT00818519 | Completed Phase 3 Results

• 3 other identifiers: 917723119632014-004612-10
• Study Type: interventional
• Target: 179
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of YAZ (drospirenone 3 mg / ethinylestradiol 20 µg) in comparison with placebo in female patients with moderate acne vulgaris over 6 treatment cycles.

Conditions

Acne Vulgaris

Keywords

Moderate Acne Vulgaris; Oral contraceptive; Female

Outcome Measures

Primary Outcomes (2)

• Percent Change From Cycle 6 to Baseline in the Total Lesion Count (Open and Closed Comedones, Papules, Pustules, and Nodules) in the FAS (Full Analysis Set)

  Acne lesions were counted by the trained designee over the entire face. All types of lesions were to be identified and separately counted, i.e., non-inflammatory open and closed comedones, and inflammatory papules, pustules, and nodules. The percent change from Cycle 6 to Baseline was calculated as (total lesion count at Baseline - total lesion count at Cycle 6)/(total lesion count at Baseline)\*100, so that improvement is indicated by a larger percent change.

  Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline

• Percent Change From Cycle 6 to Baseline in the Total Lesion Count (Open and Closed Comedones, Papules, Pustules, and Nodules) in the PPS (Per Protocol Set)

  Acne lesions were counted by the trained designee over the entire face. All types of lesions were to be identified and separately counted, i.e., non-inflammatory open and closed comedones, and inflammatory papules, pustules, and nodules. The percent change from Cycle 6 to Baseline was calculated as (total lesion count at Baseline - total lesion count at Cycle 6)/(total lesion count at Baseline)\*100, so that improvement is indicated by a larger percent change.

  Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline

Secondary Outcomes (11)

• Percentage of Participants Classified as "0" or "1" on the 6-point ISGA (Investigator Static Global Assessment) Scale at Screening Visit

  Screening visit

• Percentage of Participants Classified as "0" or "1" on the 6-point ISGA (Investigator Static Global Assessment) Scale at Cycle 1

  Cycle 1 (Day 15±3 days of Treatment Cycle 1)

• Percentage of Participants Classified as "0" or "1" on the 6-point ISGA (Investigator Static Global Assessment) Scale at Cycle 3

  Cycle 3 (Day 15±3 days of Treatment Cycle 3)

• Percentage of Participants Classified as "0" or "1" on the 6-point ISGA (Investigator Static Global Assessment) Scale at Cycle 6

  Cycle 6 (Day 15±3 days of Treatment Cycle 6)

• Percent Change From Cycle 6 to Baseline in Inflammatory Lesion Count (Papules, Pustules, and Nodules), Non-inflammatory Lesion Count

  Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline

Study Arms (2)

EE20/Drospirenone (YAZ, BAY86-5300)

EXPERIMENTAL

In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).

Drug: EE20/Drospirenone (YAZ, BAY86-5300)

Placebo

PLACEBO COMPARATOR

The participants of the placebo group received inert but identical-appearing, color-matched tablets.

Drug: Placebo

Interventions

EE20/Drospirenone (YAZ, BAY86-5300) DRUG

20µg ethinylestradiol, 3mg drospirenone, tablet, orally, opd

EE20/Drospirenone (YAZ, BAY86-5300)

Placebo DRUG

Inert tablet

Placebo

Eligibility Criteria

• Age: 14 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Women of age 14-45 years
• \>1 year post-menarche with moderate acne vulgaris who have no known contraindications to combined oral contraceptives
• Otherwise healthy, except for the presence of moderate acne

You may not qualify if:

• Pregnancy, lactation (less than three menstrual cycles since delivery, abortion, or lactation before start of treatment)
• Obesity (Body Mass Index \> 30 kg/m2)
• Hypersensitivity to any ingredient of the study drug
• Any disease or condition that may worsen under hormonal treatment

Sponsors & Collaborators

• Bayer: lead

Study Sites (7)

Unknown Facility

Guangzhou, Guangdong, 510630, China

Location

Unknown Facility

Changsha, Hunan, 410011, China

Location

Unknown Facility

Nanjing, Jiangsu, 210042, China

Location

Unknown Facility

Chengdu, Sichuan, 610041, China

Location

Unknown Facility

Beijing, 100032, China

Location

Unknown Facility

Beijing, 100853, China

Location

Unknown Facility

Shanghai, 200043, China

Location

Related Links

• Click here to find information about studies related to Bayer Healthcare products conducted in Europe

MeSH Terms

Conditions

Acne Vulgaris

Interventions

drospirenone and ethinyl estradiol combination

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: BAYER

clinical-trials-contact@bayerhealthcare.com

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2009
• First Posted: January 7, 2009
• Study Start: December 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: August 25, 2015
• Results First Posted: June 9, 2011

Record last verified: 2015-08

Locations

CN (7)