Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Flexible treatment of EE20/DRSP · 1 trial · 1 indication
The number of bleeding days per volunteer was calculated by summing up all days with bleeding intensity spotting or worse. The primary evaluation was the comparison of the flexible extended vs the standard regimen for this primary target variable, which was done for data within the first year of treatment only. As no further comparison or testing was done, no multiplicity issue arose.
Pregnancies with conception date within 4 days after end of study medication were regarded as during treatment.
The Pearl Index (PI) is defined as the number of pregnancies per 100 woman years. The 2-year PI was obtained by dividing the number of pregnancies that occurred during the two years of treatment by the time (in 100 women years) that the women were under risk of getting pregnant. 95% confidence interval according to European Medicine Agency Note for guidance on clinical investigation of steroid contraceptives in women.
Not included in this analysis are pregnancies due to subject failure eg. non-compliance with tablet intake rules.
The adjusted Pearl Index was based on pregnancies due to method failures and compliant treatment cycles, i.e. cycle length between 24 and 124 day, pill break not longer than 7 days, and number of pills taken not smaller than 90% of the number of days in that cycle minus 7 days.
| Arm | Type | Description |
|---|---|---|
| Flexible (extended) treatment of EE20/DRSP (YAZ, BAY86-5300) | EXPERIMENTAL | 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. |
| Fixed extended treatment of EE20/DRSP (YAZ, BAY86-5300) | EXPERIMENTAL | 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. |
| Standard 24+4 treatment 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 (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. |
| Name | Type | Description |
|---|---|---|
| Flexible (extended) treatment of EE20/DRSP (YAZ, BAY86-5300) | DRUG | 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. |
| Fixed extended treatment of EE20/DRSP (YAZ, BAY86-5300) | DRUG | 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. |
| Standard 24+4 treatment of EE20/DRSP (YAZ, BAY86-5300) | DRUG | 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. |
Inclusion Criteria: * Healthy women who desire contraception * smokers ≤ 30 Years old Exclusion Criteria: * Contraindication against use of hormonal contraceptives
Flexible treatment of EE20/DRSP is an oral contraceptive regimen being developed by Bayer AG. It combines ethinyl estradiol 20 mcg (EE20) and drospirenone (DRSP) in a flexible or extended dosing schedule rather than the standard 21-day on, 7-day off cycle. It is a small molecule product in the endocrine therapeutic area.
Flexible treatment of EE20/DRSP is used for contraception. The regimen is designed to allow longer cycles of active hormone intake, which can reduce the frequency of scheduled withdrawal bleeding compared with conventional oral contraceptive schedules. It is intended for use in women of reproductive age.
Bayer AG develops Flexible treatment of EE20/DRSP. Bayer trades on the OTC market under the ticker BAYRY. The product is also referenced by the names YAZ and BAY86-5300, so readers searching those terms are looking at the same ethinyl estradiol and drospirenone combination.
Flexible treatment of EE20/DRSP is in Phase 3 clinical development. It is an investigational regimen and is not described as approved. The Phase 3 program has completed, with one trial recorded and no active trials currently listed for this flexible dosing approach.
Flexible treatment of EE20/DRSP has been studied in the Phase 3 trial NCT00266032, titled Study on Safety and Efficacy of an Oral Contraceptive in Long Cycles. That completed trial enrolled 1,166 female participants aged 18 years and older across Canada, Germany, and the Netherlands, and used an active-controlled design.
Flexible treatment of EE20/DRSP is also known as YAZ and BAY86-5300. These names refer to the same ethinyl estradiol 20 mcg and drospirenone combination from Bayer. The flexible or extended treatment label describes the dosing schedule studied, while YAZ is the brand name associated with the product.