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

Bayer

Status and phase: Completed; Phase 3

Conditions: Contraception

Treatments: Drug: Fixed extended treatment of EE20/DRSP (YAZ, BAY86-5300); Drug: Standard 24+4 treatment of EE20/DRSP (YAZ, BAY86-5300); Drug: Flexible (extended) treatment of EE20/DRSP (YAZ, BAY86-5300)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00266032

2005-002125-32 (EudraCT Number)

91450

308683 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,166 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Contraindication against use of hormonal contraceptives

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,166 participants in 3 patient groups

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

Experimental group

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.

Treatment:

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

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

Experimental group

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.

Treatment:

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

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

Active Comparator group

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.

Treatment:

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