Estradiol + eclometrine (segesterone)

Unassigned

New Medicines

Annovera (US) · Contraception

Information

Annovera (US)
New molecular entity
Not Known
TherapeuticsMD

Development and Regulatory status

None
None
Approved (Licensed)

Aug 18: FDA advise that women aged >35 who smoke should not use Annovera, and the ring carries a boxed warning relating to cigarette smoking and serious cardiovascular events, similar to other hormonal contraceptives. The FDA is requiring postmarket studies on the risk of venous thromboembolism and the effects of tampon use and CYP3A modulating drugs on Annovera’s pharmacokinetics.[2]


Aug 18: Approved by FDA. It is expected that Annovera will be fully commercially available in late 2019 or early 2020.[2]


Jan 18: Filed for approval with US FDA.[2]

Category

A self-administered vaginal ring composed of ethinyl estradiol + segestrerone acetate (a 4th generation progestin). Each cycle will consist of 21 days of vaginal ring use followed by 7 vaginal ring-free days - can be used for up to 1 year.
The last survey on contraceptive use was done by the Office for National Statistics (ONS) in 2008-9 and at that time showed that 75% of women use some form of contraception [1].
Contraception
Vaginal

Trial or other data

Jan 18: Two pivotal PIII trials (NCT00455156 and NCT00263341) involving 2270 healthy women aged 18 to 40 years evaluated its safety and efficacy. These showed that ~2-4 women out of 100 may get pregnant during the first year they use Annovera as directed.[2,3]


A self-administered silicone rubber vaginal ring composed of ethinyl estradiol + segestrerone acetate (a 4th generation progestin) has been developed by the Population Council (USA) who is developing it with TherapeuticsMD in the USA. The ring is designed to last for 1 year before being replaced, allowing long term delivery of the drugs. It is washed and stored in a compact case for the seven days it´s not in use during a four-week menstrual cycle. It does not require refrigeration and can withstand storage up to 86°F (30°C).[2,3]