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

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

Sponsors

Lead Sponsor: Bayer

Source Bayer
Brief Summary

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

Detailed Description

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.

Overall Status Completed
Start Date December 2005
Completion Date October 2008
Primary Completion Date October 2008
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Number of Days With Bleeding Including Spotting up to 1 year
Number of Unintended Pregnancies in Yaz Flexible Arm up to 2 years
Pearl Index Up to 2 years
Number of Unintended Pregnancies Due to Method Failure Up to 2 years
Adjusted Pearl Index Up to 2 years
Secondary Outcome
Measure Time Frame
Number of Days With Bleeding Excluding Spotting up to 1 year
Number of Bleeding Days During One Year of Treatment in Subjects With at Least 248 Days of Exposure Normalized to 372 Days up to 1 year
Number of Bleeding / Spotting Days by 90-day Reference Period up to 1 year
Number of Bleeding / Spotting Episodes in 90 Day Reference Period Up to one year
Days With Scheduled Versus Unscheduled Bleeding Up to one year
Enrollment 1166
Condition
Intervention

Intervention Type: Drug

Intervention Name: Flexible (extended) treatment of EE20/DRSP (YAZ, BAY86-5300)

Description: 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.

Arm Group Label: Flexible (extended) treatment of EE20/DRSP (YAZ, BAY86-5300)

Intervention Type: Drug

Intervention Name: Fixed extended treatment of EE20/DRSP (YAZ, BAY86-5300)

Description: 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.

Arm Group Label: Fixed extended treatment of EE20/DRSP (YAZ, BAY86-5300)

Intervention Type: Drug

Intervention Name: Standard 24+4 treatment of EE20/DRSP (YAZ, BAY86-5300)

Description: 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.

Arm Group Label: Standard 24+4 treatment of EE20/DRSP (YAZ, BAY86-5300)

Eligibility

Criteria:

Inclusion Criteria:

- Healthy women who desire contraception

- smokers ≤ 30 Years old

Exclusion Criteria:

- Contraindication against use of hormonal contraceptives

Gender: Female

Minimum Age: 18 Years

Maximum Age: 35 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Bayer Study Director Study Director Bayer
Location
Facility:
| Drummondville, Quebec, J2B 1H8, Canada
| Montreal, Quebec, H1T 1P6, Canada
| Pointe-Claire, Quebec, H9R 4S3, Canada
| Shawinigan, Quebec, G9N 2H6, Canada
| Ste-Foy, Quebec, G1V 4X7, Canada
| Quebec, G1S 2L6, Canada
| Ettlingen, Baden-Württemberg, 76275, Germany
| Karlsruhe, Baden-Württemberg, 76199, Germany
| Ansbach, Bayern, 91522, Germany
| Krumbach, Bayern, 86381, Germany
| Nürnberg, Bayern, 90491, Germany
| Dietzenbach, Hessen, 63128, Germany
| Frankfurt, Hessen, 60322, Germany
| Frankfurt, Hessen, 60439, Germany
| Frankfurt, Hessen, 65929, Germany
| Frankfurt, Hessen, 65936, Germany
| Mühlheim, Hessen, 63165, Germany
| Bovenden, Niedersachsen, 37120, Germany
| Hannover, Niedersachsen, 30459, Germany
| Osnabrück, Niedersachsen, 49074, Germany
| Bernburg, Sachsen-Anhalt, 06406, Germany
| Jessen, Sachsen-Anhalt, 06917, Germany
| Magdeburg, Sachsen-Anhalt, 39104, Germany
| Magdeburg, Sachsen-Anhalt, 39126, Germany
| Magdeburg, Sachsen-Anhalt, 39130, Germany
| Wurzen, Sachsen, 04808, Germany
| Gera, Thüringen, 07545, Germany
| Jena, Thüringen, 07747, Germany
| Kahla, Thüringen, 07768, Germany
| Berlin, 10115, Germany
| Berlin, 10247, Germany
| Berlin, 12435, Germany
| Berlin, 13187, Germany
| Hamburg, 21073, Germany
| Groningen, 9713 GZ, Netherlands
Location Countries

Canada

Germany

Netherlands

Verification Date

October 2014

Responsible Party

Type: Sponsor

Has Expanded Access No
Number Of Arms 3
Arm Group

Label: Flexible (extended) treatment of EE20/DRSP (YAZ, BAY86-5300)

Type: Experimental

Description: 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.

Label: Fixed extended treatment of EE20/DRSP (YAZ, BAY86-5300)

Type: Experimental

Description: 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.

Label: Standard 24+4 treatment of EE20/DRSP (YAZ, BAY86-5300)

Type: Active Comparator

Description: 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.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: None (Open Label)

Source: ClinicalTrials.gov