Estetrol/Drospirenone Drug-Drug interaction (DDI) Study (QCL118187)

• Research type

  Research Study

• Full title

  An open-label, two-way cross-over study to determine the effect of multiple doses of valproic acid on the pharmacokinetics and safety of a single oral dose of estetrol/drospirenone in healthy female subjects

• IRAS ID

  236120

• Contact name

• Sponsor organisation

  Estetra SPRL

• Eudract number

  2017-004280-12

• Duration of Study in the UK

  0 years, 3 months, 23 days

• Research summary

  The sponsor, Estetra SPRL, is developing a new combination oral contraceptive medicine (E4/DRSP). A contraceptive medicine is a medicine that prevents pregnancy from occurring. Combined oral contraceptives (commonly known as the combined contraceptive pill or “the combined pill”) are hormonal contraceptives that are taken as tablets by mouth. There are many brands of combined oral contraceptive but all contain two types of hormone; progestogen and oestrogen. This combination has been used as a method of contraception for over 50 years.

  The test medicine will contain a type of oestrogen called estetrol (E4) which is naturally produced by the human foetus’s liver during pregnancy and reaches the mother’s blood through the placenta. E4 is included within contraception as it prevents ovulation (the release of eggs from the ovaries).

  The test medicine will also contain Drospirenone (DRSP). DRSP is a progestogen that is currently used in a number of marketed contraceptive medicines. In addition to preventing ovulation, DRSP changes the lining of the womb and mucus at the neck of the womb to prevent sperm from entering and pregnancy from developing. It has also been shown to be beneficial in improving the condition of the users skin and stopping the body from holding too much water, which is a common problem with other progestogens.

  The ingredients being used in this test medicine have been man-made by chemical synthesis.

  The purpose of this study is to see how taking another marketed medication, called valproic acid (VAL), normally given for epilepsy (seizures), affects how well the body takes up E4/DRSP.

  The study will consist of 2 study periods involving up to 24 healthy female volunteers. Each volunteer will receive a single dose of test medicine by itself in one period and the test medicine with VAL in the other study period.

• REC name

  Wales REC 2

• REC reference

  18/WA/0007

• Date of REC Opinion

  24 Jan 2018

• REC opinion

  Favourable Opinion