Study on Safety and Efficacy of an Oral Contraceptive in Long Cycles

Official Title: “A Multicenter, Open, Randomized, Parallel Group Comparison to Assess the Safety and Efficacy of the Oral Contraceptive SH T00186D (0.02 mg Ethinylestradiol as Betadex Clathrate and 3 mg Drospirenone) in Two Variations of an Extended Regimen vs. a Standard Regimen (24 + 4 Days) in 1122 Healthy Female Volunteers for One Year, Followed by a One Year Safety Extension”

The purpose of the study is to determine safety and efficacy of long-cycle regimens of an oral contraceptive.

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG (BSP AG), Germany.

Bayer Schering Pharma AG, Germany is the sponsor of the trial.

The previously posted secondary Outcome Measure "Parameters of safety and tolerability" has been removed from result posting as it is covered by the Adverse Event section.

Intervention(s) in this Clinical Trial

• Drug: Flexible (extended) treatment of EE20/DRSP (YAZ, BAY86-5300)
  • 3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, 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 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
• Drug: Fixed extended treatment of EE20/DRSP (YAZ, BAY86-5300)
  • 3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected.
• Drug: Standard 24+4 treatment of EE20/DRSP (YAZ, BAY86-5300)
  • 13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets (20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone) followed by 4 days of placebo tablets, 13 withdrawal bleeding episodes during one year of treatment were expected.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Flexible (extended) treatment of EE20/DRSP (YAZ, BAY86-5300)
  • 3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, 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 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
• Experimental: Fixed extended treatment of EE20/DRSP (YAZ, BAY86-5300)
  • 3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected.
• Active Comparator: Standard 24+4 treatment of EE20/DRSP (YAZ, BAY86-5300)
  • 13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets (20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone) followed by 4 days of placebo tablets, 13 withdrawal bleeding episodes during one year of treatment were expected.

Primary Measures

• Number of Days With Bleeding Including Spotting
  • Time Frame: up to 1 year
    Safety Issue?: No
• Number of Unintended Pregnancies in Yaz Flexible Arm
  • Time Frame: up to 2 years
    Safety Issue?: No
• Pearl Index
  • Time Frame: Up to 2 years
    Safety Issue?: No
• Number of Unintended Pregnancies Due to Method Failure
  • Time Frame: Up to 2 years
    Safety Issue?: No
• Adjusted Pearl Index
  • Time Frame: Up to 2 years
    Safety Issue?: No

Secondary Measures

• Number of Days With Bleeding Excluding Spotting
  • Time Frame: up to 1 year
    Safety Issue?: No
• Number of Bleeding Days During One Year of Treatment in Subjects With at Least 248 Days of Exposure Normalized to 372 Days
  • Time Frame: up to 1 year
    Safety Issue?: No
• Number of Bleeding / Spotting Days by 90-day Reference Period
  • Time Frame: up to 1 year
    Safety Issue?: No
• Number of Bleeding / Spotting Episodes in 90 Day Reference Period
  • Time Frame: Up to one year
    Safety Issue?: No
• Days With Scheduled Versus Unscheduled Bleeding
  • Time Frame: Up to one year
    Safety Issue?: No

Inclusion Criteria:

• Healthy women who desire contraception
• smokers ≤ 30 Years old

Exclusion Criteria:

• Contraindication against use of hormonal contraceptives

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 35 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: Bayer Industry

Overall Clinical Trial Officials and Contacts

Bayer Study Director Study Director Bayer  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00266032

Study ID Number: 91450

ClinicalTrials.gov Identifier: NCT00266032

Health Authority: Canada: Health Canada

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