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

Bayer

Status and phase: Completed; Phase 3

Conditions: Contraception; Contraceptives, Oral; Ovulation Inhibition

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00567164

91698

311642 (Other Identifier)

Details and patient eligibility

About

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

Full description

The primary efficacy parameter is the number of observed unintended pregnancy during 1 year of treatment. Secondary efficacy parameter include bleeding parameters and menstrual related symptoms Safety parameters included assessment of adverse events, laboratory evaluations.

Enrollment: 1,887 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,887 participants in 3 patient groups

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

Experimental group

Description:

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

Treatment:

Drug: EE20/DRSP (BAY86-5300)

Drug: EE20/DRSP (BAY86-5300)

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

Experimental group

Description:

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.

Treatment:

Drug: EE20/DRSP (BAY86-5300)

Drug: EE20/DRSP (BAY86-5300)

Conventional regimen 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 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.

Treatment:

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