Mithra Pharmaceuticals closes enrolment in Phase III trial of contraceptive Estelle

7th February 2017 (Last Updated February 7th, 2017 18:30)

Belgium-based pharmaceutical firm Mithra Pharmaceuticals has closed enrolment in the Phase III trial of its oral contraceptive Estelle in Europe and Russia.

Belgium-based pharmaceutical firm Mithra Pharmaceuticals has closed enrolment in the Phase III trial of its oral contraceptive Estelle in Europe and Russia.

Estelle is a combined oral contraceptive (COC) developed using 15mg of E4 and 3mg of DRSP.

The open-label single arm Phase III European trial will assess the safety and efficacy of Estelle in approximately 1,550 patients over a period of 12 months.

The firm has screened 1,709 patients to date and expects that a minimum of 1,550 will qualify for the enrolment in the study.

Mithra Pharmaceuticals chief executive officer Francois Fornieri said: "Initial studies have shown the potential advantages of Estetrol, including a reduction in side effects such as the risk of venous thromboembolism, an increase in body weight  and undesired bleeding whilst on the pill.

"The firm has screened 1,709 patients to date and expects that a minimum of 1,550 will qualify for the enrolment in the study."

"We are on track to complete the trial in 2018 and hope to be able to provide women globally with a novel contraceptive option with a better safety and efficacy profile compared to currently available treatments.”

The study will assess the efficacy, cycle control and tolerance of the COC in patients aged between 18-50 years, 1,350 of which will be 18-35.

The trial's primary objective is to measure the number of pregnancies per 100 women every 12 months of exposure in patients aged 18-35.

With results expected by next year, the study is being conducted in around 69 centres across Europe and Russia.

A second Phase III study in the US and Canada began enrolment in September last year.