Company:

Ferring

Progestin

Progesterone 100mg; vaginal insert.

To support embryo implantation and early pregnancy by supplementation of corpus luteal function as part of an Assisted Reproductive Technology (ART) treatment program for infertile women.

Progesterone supplementation is used to provide support for the luteal phase, preparing the endometrium for implantation of the embryo, and for early pregnancy. Endometrin is a quickly dissolving tablet containing micronized progesterone that is vaginally inserted. After insertion, the tablet disperses locally, rapidly achieving local levels of progesterone.

An active-controlled study evaluated the efficacy of 10 weeks of treatment with two different dosing regimens of Endometrin (100mg twice daily and 100mg three times daily). Efficacy was assessed on the end-point of ongoing pregnancies, defined as the presence of at least one fetal heartbeat seen on ultrasound at 6 weeks post-embryo transfer. The ongoing pregnancy rates for those treated with both regimens were non-inferior to the ongoing pregnancy rate for patients treated with the active comparator.

100mg vaginally 2 or 3 times daily starting at oocyte retrieval for up to 10 weeks total duration. ≥35yrs: efficacy not clearly established; see literature.

Not applicable.

Breast carcinoma. Liver dysfunction or disease. Missed abortion. Ectopic pregnancy. Thrombophlebitis or thromboembolic disorders.

Depression. Discontinue if signs of thrombotic disorders (eg, thrombophlebitis, cerebrovascular disorders, pulmonary embolism, retinal thrombosis) occur. Pregnancy outcome: see literature. Nursing mothers.

Concomitant other vaginal products (eg, antifungals): not recommended.

GI upset, abdominal pain, post-oocyte retrieval pain, ovarian hyperstimulation syndrome, headache, uterine spasm, vaginal bleeding, fatigue, urinary tract infection.

Inserts—21 (w. applicators)

11/7/07