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First oral combined estetrol contraceptive available in UK

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The first oral contraceptive tablet using a combination of estetrol (E4) and drospirenone (DRSP) is available in the UK.

Oral contraceptive pills

Gedeon Richter has announced that its combined oral contraceptive Drovelis® is the first tablet containing estetrol (E4) and drospirenone (DRSP) to be made available on the NHS in England.

 

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The drug (14.2mg estetrol and 3mg drospirenone) is the first oral combined contraceptive containing a new, synthetic natural oestrogen to be offered to patients in the UK.

“For the first time, we are now able to prescribe a combined hormonal contraceptive tablet containing synthetic E4, plus the well-known progestogen DRSP,” explained Dr Diana Mansour, Consultant in Community Gynaecology and Reproductive Health Care, Newcastle upon Tyne.

The Medicines and Healthcare products Regulatory Agency (MHRA) granted a UK licence for the product in 2021.

This Marketing Authorisation was based on two successful Phase III randomised control trials. The first: E4 FREEDOM trial, conducted in Europe and Russia, enrolled 1,553 women aged between 18 and 50 years. The second: Study MIT-Es0001-C302 enrolled 1,864 women between 16 and 50 years in the US and Canada.

The primary endpoint for both trials was 13-cycle Pearl Index (PI) (number of pregnancies per 100 woman-years of exposure) for women aged 18 to 35 years and 16 to 35 years, respectively.  

The PI from E4 FREEDOM for E4/DRSP in at-risk cycles was 0.47 (95 percent Confidence Interval (CI): 0.15-1.11). The PI from Study MIT-Es0001-C302 reported more pregnancies compared to E4 FREEDOM, with an at-risk cycle PI of 2.65 (95 percent CI: 1.73, 3.88).

The secondary endpoint for both trials was to evaluate the contraceptive efficacy, bleeding patterns and overall safety of the drug in women of the reproductive years 18-50 and 16-50.

The current known safety profile for the new drug combination is corroborative with the safety data for combined oral contraceptives.

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