Efficacy and Safety of Two Flexible Extended Regimens of BAY86-5300 (SH T00186D) in Comparison With the Conventional Regimen of YAZ

NCT00567164 | Completed Phase 3 Results

• 2 other identifiers: 91698311642
• Study Type: interventional
• Target: 1,887
• Locations: 1 country
• Sites: 85

Brief Summary

The purpose of this study is to determine whether the study drug is safe and effective.

Conditions

Contraception; Ovulation Inhibition; Contraceptives, Oral

Keywords

Oral Contraception; Birth Control pill; Healthy women requesting oral contraception; Contraceptive efficacy

Outcome Measures

Primary Outcomes (1)

• Pearl Index

  The Pearl Index (PI) is the number of pregnancies per 100 woman years. The PI is obtained by dividing the number of pregnancies during treatment (conception date on/after the 1st day of treatment and not later than last day of treatment +14 days) by the treatment exposure time (in 100 women years) that the women were under risk of getting pregnant. The Pearl Index was not calculated individually for either the Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) treatment arm, nor for the Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) treatment arm, because the low sample size in these treatment arms (approximately. 200 subjects per group) did not allow a reliable PI calculation of these groups alone.

  Up to 1 year

Secondary Outcomes (23)

• Number of Bleeding Days (Including Spotting Days)

  Up to 1 year

• Number of Bleeding Days (Excluding Spotting Days)

  Up to 1 year

• Number of Days With Bleeding (Including and Excluding Spotting) Within 90-day Reference Period 1.

  Day 1 to Day 90

• Number of Days With Bleeding (Including and Excluding Spotting) Within 90-day Reference Period 2.

  Day 91 to Day 180

• Number of Days With Bleeding (Including and Excluding Spotting) Within 90-day Reference Period 3

  Day 181 to Day 270

Study Arms (3)

Flexible (extended) regimen no. 1 of EE20/DRSP (BAY86-5300)

EXPERIMENTAL

Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment

Drug: EE20/DRSP (BAY86-5300)

Flexible (extended) regimen no. 2 of EE20/DRSP (BAY86-5300)

EXPERIMENTAL

Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.

Drug: EE20/DRSP (BAY86-5300)

Conventional regimen of EE20/DRSP (YAZ, BAY86-5300)

ACTIVE COMPARATOR

13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of tablets without active substance (together resulting in one cycle of 24+4 standard treatment). 13 withdrawal bleeding episodes during one year of treatment were expected.

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

Interventions

EE20/DRSP (BAY86-5300) DRUG

Combination tablet containing 0.02 mg ethinyl estradiol as betadex clathrate and 3.0 mg drospirenone

Also known as: SH T00186D

Flexible (extended) regimen no. 1 of EE20/DRSP (BAY86-5300)

EE20/DRSP (YAZ, BAY86-5300) DRUG

Fixed package per cycle containing combination tablets containing 0.02 mg ethinyl estradiol as betadex clathrate and 3.0 mg drospirenone (24 per cycle) + tablets without active substance (4 per cycle)

Also known as: SH T00186D

Conventional regimen of EE20/DRSP (YAZ, BAY86-5300)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- Healthy women between 18 and 45 requesting oral contraception. Smokers may not exceed 35 years of age.

You may not qualify if:

• \- The use of steroidal oral contraceptives, or any drug that could alter oral contraception metabolism will be prohibited during the study.

Sponsors & Collaborators

• Bayer: lead

Study Sites (85)

Unknown Facility

Montgomery, Alabama, 36116, United States

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Chandler, Arizona, 85224, United States

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Mesa, Arizona, 85203, United States

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Mesa, Arizona, 85213, United States

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Phoenix, Arizona, 85031, United States

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Tempe, Arizona, 85283, United States

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Tucson, Arizona, 85712, United States

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Tucson, Arizona, 85741, United States

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Anaheim, California, 92801-2811, United States

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Beverly Hills, California, 90212, United States

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Pacific Palisades, California, 90272, United States

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San Diego, California, 92103, United States

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San Diego, California, 92108, United States

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Santa Ana, California, 92705, United States

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Vallejo, California, 94589, United States

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Colorado Springs, Colorado, 80909, United States

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Denver, Colorado, 80218, United States

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Greenwood Village, Colorado, 80111, United States

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Littleton, Colorado, 80123, United States

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Waterbury, Connecticut, 06708, United States

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Boynton Beach, Florida, 33472-2952, United States

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Brooksville, Florida, 34613, United States

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Clearwater, Florida, 33759, United States

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Coral Gables, Florida, 33134, United States

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Crystal River, Florida, 34429, United States

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Jacksonville, Florida, 32259, United States

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Lake Worth, Florida, 33461, United States

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Miami, Florida, 33186, United States

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Naples, Florida, 34102, United States

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North Miami, Florida, 33161, United States

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Pembroke Pines, Florida, 33024, United States

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Plantation, Florida, 33313, United States

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South Miami, Florida, 33143, United States

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St. Petersburg, Florida, 33709, United States

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West Palm Beach, Florida, 33409, United States

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Atlanta, Georgia, 30328, United States

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Decatur, Georgia, 30034, United States

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Boise, Idaho, 83702, United States

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Boise, Idaho, 83704, United States

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Idaho Falls, Idaho, 83404, United States

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Champaign, Illinois, 61820, United States

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Chicago, Illinois, 60612, United States

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Newburgh, Indiana, 47630, United States

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Wichita, Kansas, 67207, United States

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Lexington, Kentucky, 40509, United States

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Marrero, Louisiana, 70072, United States

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Paw Paw, Michigan, 49079, United States

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Chesterfield, Missouri, 63017, United States

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Kansas City, Missouri, 64114, United States

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Lincoln, Nebraska, 68510, United States

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Las Vegas, Nevada, 89104, United States

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Las Vegas, Nevada, 89109, United States

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LasVegas, Nevada, 89106, United States

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Moorestown, New Jersey, 08057, United States

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New Brunswick, New Jersey, 08901, United States

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Rochester, New York, 14618, United States

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Durham, North Carolina, 27713, United States

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New Bern, North Carolina, 28562, United States

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Winston-Salem, North Carolina, 27103, United States

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Bismarck, North Dakota, 58501, United States

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Cleveland, Ohio, 44122, United States

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Columbus, Ohio, 43213, United States

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Oklahoma City, Oklahoma, 73112, United States

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Portland, Oregon, 97239-3011, United States

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Portland, Oregon, 97239, United States

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Jenkintown, Pennsylvania, 19046, United States

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Philadelphia, Pennsylvania, 19114, United States

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Pittsburgh, Pennsylvania, 15206, United States

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Columbia, South Carolina, 29201, United States

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Mt. Pleasant, South Carolina, 29464, United States

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Chattanooga, Tennessee, 37404, United States

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Jackson, Tennessee, 38305-3618, United States

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Knoxville, Tennessee, 37920, United States

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Memphis, Tennessee, 38120, United States

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Nashville, Tennessee, 37203, United States

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Colleyville, Texas, 76034, United States

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Corpus Christi, Texas, 78414, United States

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Dallas, Texas, 75234, United States

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Houston, Texas, 77054, United States

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Houston, Texas, 77074, United States

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West Jordan, Utah, 84088, United States

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Richmond, Virginia, 23233, United States

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Richmond, Virginia, 23294, United States

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Seattle, Washington, 98105, United States

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Spokane, Washington, 99207, United States

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Related Publications (1)

• Jensen JT, Garie SG, Trummer D, Elliesen J. Bleeding profile of a flexible extended regimen of ethinylestradiol/drospirenone in US women: an open-label, three-arm, active-controlled, multicenter study. Contraception. 2012 Aug;86(2):110-8. doi: 10.1016/j.contraception.2011.12.009. Epub 2012 Jan 26.

  PMID: 22281416 RESULT

MeSH Terms

Interventions

drospirenone and ethinyl estradiol combination

Limitations and Caveats

The Flexible (extended) Regimen no. 1 Group was enrolled under slightly different eligibility criteria for age, BMI, and fertility status than the other two treatment groups. This did not affect the results or interpretation of the results.

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: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2007
• First Posted: December 4, 2007
• Study Start: October 1, 2007
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: March 12, 2014
• Results First Posted: March 12, 2014

Record last verified: 2014-01

Locations

US (85)