[Script Info]
Title: 
[Events]
Format: Layer, Start, End, Style, Name, MarginL, MarginR, MarginV, Effect, Text
Dialogue: 0,0:00:09.45,0:00:12.74,Default,,0000,0000,0000,,Progesterone is a key pregnancy hormone with modulating effects
Dialogue: 0,0:00:12.74,0:00:15.74,Default,,0000,0000,0000,,that are essential for successful reproduction.
Dialogue: 0,0:00:17.76,0:00:22.99,Default,,0000,0000,0000,,For patients going through In Vitro Fertilization and other Assisted Reproductive Technologies,
Dialogue: 0,0:00:22.99,0:00:26.21,Default,,0000,0000,0000,,progesterone supplementation is standard practice.
Dialogue: 0,0:00:26.93,0:00:32.21,Default,,0000,0000,0000,,During oocyte retrieval, removal or disruption of the granulosa cells lining the follicle,
Dialogue: 0,0:00:32.21,0:00:35.56,Default,,0000,0000,0000,,can impair progesterone production from the corpus luteum.
Dialogue: 0,0:00:36.74,0:00:40.32,Default,,0000,0000,0000,,Use of GnRH analogues used to prevent early ovulation
Dialogue: 0,0:00:40.32,0:00:43.31,Default,,0000,0000,0000,,can also suppress luteal function.
Dialogue: 0,0:00:47.93,0:00:52.21,Default,,0000,0000,0000,,(First-Generation Progesterone Supplements)
Dialogue: 0,0:00:53.25,0:00:59.01,Default,,0000,0000,0000,,Intramuscular injection of progesterone in an oil-based suspension is one common delivery method.
Dialogue: 0,0:01:00.09,0:01:05.25,Default,,0000,0000,0000,,It is not approved by the FDA for women undergoing IVF or other ART treatments.
Dialogue: 0,0:01:06.25,0:01:10.03,Default,,0000,0000,0000,,Oil-based injections have been associated with a number of side effects,
Dialogue: 0,0:01:10.03,0:01:15.82,Default,,0000,0000,0000,,including pain at the injection site, inflammatory reactions and abscess formation.
Dialogue: 0,0:01:16.18,0:01:19.26,Default,,0000,0000,0000,,The aid of another person is often required.
Dialogue: 0,0:01:19.80,0:01:24.97,Default,,0000,0000,0000,,In 1997, Crinone progesterone gel 8% was approved by the FDA
Dialogue: 0,0:01:24.97,0:01:30.86,Default,,0000,0000,0000,,for vaginal administration during ART treatment for infertile women with progesterone deficiency.
Dialogue: 0,0:01:31.50,0:01:37.79,Default,,0000,0000,0000,,Crinone gel is a water-insoluble Polycarbophil emulsion that contains micronized progesterone.
Dialogue: 0,0:01:40.05,0:01:45.63,Default,,0000,0000,0000,,Crinone is delivered once or twice a day to the vagina via a prefilled disposable applicator.
Dialogue: 0,0:01:47.13,0:01:51.36,Default,,0000,0000,0000,,Once administered, the gel adheres to the vaginal wall through hydrogen bonds.
Dialogue: 0,0:01:52.26,0:01:54.47,Default,,0000,0000,0000,,Vaginal moisture penetrates the emulsion,
Dialogue: 0,0:01:54.47,0:01:57.48,Default,,0000,0000,0000,,beginning a slow process of progesterone release
Dialogue: 0,0:01:57.48,0:02:00.10,Default,,0000,0000,0000,,and absorption by the vaginal epithelia.
Dialogue: 0,0:02:01.30,0:02:04.20,Default,,0000,0000,0000,,Because it is bioadhesive and water insoluble,
Dialogue: 0,0:02:04.20,0:02:06.71,Default,,0000,0000,0000,,the gel can remain adhered to the vaginal wall
Dialogue: 0,0:02:06.71,0:02:09.54,Default,,0000,0000,0000,,even after the progesterone has been absorbed.
Dialogue: 0,0:02:10.68,0:02:16.73,Default,,0000,0000,0000,,With each additional dose, 1.125 grams of gel are delivered and can contribute to build up.
Dialogue: 0,0:02:17.09,0:02:21.08,Default,,0000,0000,0000,,This may require manual removal prior to embryo transfer.
Dialogue: 0,0:02:22.74,0:02:26.48,Default,,0000,0000,0000,,If gel accumulates, vaginal discharge appearing as white globules
Dialogue: 0,0:02:26.48,0:02:30.22,Default,,0000,0000,0000,,may occur as the gel is discarded and exits the body.
Dialogue: 0,0:02:35.28,0:02:39.32,Default,,0000,0000,0000,,(ENDOMETRIN Vaginal Insert\NAdvancing the ART of Luteal Phase Support)
Dialogue: 0,0:02:41.20,0:02:46.49,Default,,0000,0000,0000,,In 2007, endometrial progesterone vaginal insert was approved by the FDA
Dialogue: 0,0:02:46.49,0:02:50.89,Default,,0000,0000,0000,,as an alternative to vaginal gel for women undergoing ART treatment.
Dialogue: 0,0:02:52.97,0:02:55.98,Default,,0000,0000,0000,,ENDOMETRIN is a 100-milligram vaginal insert
Dialogue: 0,0:02:55.100,0:02:58.28,Default,,0000,0000,0000,,administered two or three times daily
Dialogue: 0,0:02:58.28,0:03:00.74,Default,,0000,0000,0000,,with a sterile disposable applicator.
Dialogue: 0,0:03:02.24,0:03:07.48,Default,,0000,0000,0000,,In a moist environment, the bicarbonate delivery system of the insert is highly soluble.
Dialogue: 0,0:03:09.50,0:03:13.73,Default,,0000,0000,0000,,Vaginal moisture penetrates the insert, causing an acid-based reaction.
Dialogue: 0,0:03:14.69,0:03:18.76,Default,,0000,0000,0000,,The insert breaks down, releasing progesterone into the aqueous environment.
Dialogue: 0,0:03:19.20,0:03:24.79,Default,,0000,0000,0000,,Progesterone, being a hydrophobic molecule, rushes towards the vaginal epithelia,
Dialogue: 0,0:03:24.79,0:03:30.33,Default,,0000,0000,0000,,where it is absorbed by serum proteins and delivered to the endometrium via local circulation.
Dialogue: 0,0:03:31.07,0:03:34.51,Default,,0000,0000,0000,,Unlike crinone, which is dosed 90 milligrams once daily,
Dialogue: 0,0:03:34.51,0:03:38.72,Default,,0000,0000,0000,,ENDOMETRIN is dosed 100 milligrams two or three times daily
Dialogue: 0,0:03:38.72,0:03:42.50,Default,,0000,0000,0000,,due to differences in the pharmacokinetic profile of the two products.
Dialogue: 0,0:03:42.78,0:03:48.50,Default,,0000,0000,0000,,In a randomized open-label pharmacokinetic study with 18 women aged 18-40,
Dialogue: 0,0:03:48.72,0:03:54.53,Default,,0000,0000,0000,,both doses of endometrium reached steady-state progesterone concentrations in about 24 hours,
Dialogue: 0,0:03:54.53,0:03:58.49,Default,,0000,0000,0000,,while the gel did not reach steady state by the end of the fifth day.
Dialogue: 0,0:03:58.63,0:04:02.83,Default,,0000,0000,0000,,Efficacy was not a parameter being examined in this PK study.
Dialogue: 0,0:04:05.35,0:04:07.53,Default,,0000,0000,0000,,because of its bicarbonate formulation,
Dialogue: 0,0:04:07.53,0:04:14.77,Default,,0000,0000,0000,,The majority of each ENDOMETRIN vaginal insert ends up as water and carbon dioxide, resulting in minimal discharge.
Dialogue: 0,0:04:17.51,0:04:21.78,Default,,0000,0000,0000,,With the introduction of these FDA-approved vaginal progesterone preparations,
Dialogue: 0,0:04:21.90,0:04:26.20,Default,,0000,0000,0000,,relying on painful intramuscular injections is no longer necessary.
Dialogue: 0,0:04:27.72,0:04:36.50,Default,,0000,0000,0000,,Both FDA-approved vaginal preparations have been proven as efficacious as IM delivery of progesterone in randomized prospective trials.
Dialogue: 0,0:04:36.98,0:04:40.78,Default,,0000,0000,0000,,However, only ENDOMETRIN provides rapid progesterone uptake
Dialogue: 0,0:04:40.78,0:04:43.73,Default,,0000,0000,0000,,while causing no build-up and minimal discharge.
Dialogue: 0,0:04:47.43,0:04:50.57,Default,,0000,0000,0000,,ENDOMETRIN progesterone vaginal insert is indicated to
Dialogue: 0,0:04:50.57,0:04:56.94,Default,,0000,0000,0000,,support embryo implantation and early pregnancy by supplementation of corpus luteum function
Dialogue: 0,0:04:56.94,0:05:03.24,Default,,0000,0000,0000,,as part of an Assisted Reproductive Technology (ART) treatment program for infertile women.
Dialogue: 0,0:05:03.80,0:05:05.87,Default,,0000,0000,0000,,Important Safety Information
Dialogue: 0,0:05:06.15,0:05:10.19,Default,,0000,0000,0000,,ENDOMETRIN should not be used in individuals with any of the following conditions:
Dialogue: 0,0:05:10.19,0:05:14.81,Default,,0000,0000,0000,,previous allergic reactions to progesterone or any of the ingredients of endometrium,
Dialogue: 0,0:05:14.81,0:05:18.34,Default,,0000,0000,0000,,known missed abortion or ectopic pregnancy, liver disease,
Dialogue: 0,0:05:18.34,0:05:20.25,Default,,0000,0000,0000,,known or suspected breast cancer,
Dialogue: 0,0:05:20.25,0:05:25.07,Default,,0000,0000,0000,,active arterial or venous thromboembolism or severe thrombophlebitis,
Dialogue: 0,0:05:25.07,0:05:27.03,Default,,0000,0000,0000,,or a history of these events.
Dialogue: 0,0:05:27.21,0:05:31.12,Default,,0000,0000,0000,,The physician should be alert to the earliest signs of myocardial infarction,
Dialogue: 0,0:05:31.12,0:05:35.55,Default,,0000,0000,0000,,cerebrovascular disorders, arterial or venous thromboembolism
Dialogue: 0,0:05:35.55,0:05:38.46,Default,,0000,0000,0000,,(venous thromboembolism or pulmonary embolism),
Dialogue: 0,0:05:38.46,0:05:40.100,Default,,0000,0000,0000,,thrombophlebitis or retinal thrombosis.
Dialogue: 0,0:05:41.08,0:05:44.77,Default,,0000,0000,0000,,ENDOMETRIN should be discontinued if any of these are suspected.
Dialogue: 0,0:05:44.77,0:05:47.75,Default,,0000,0000,0000,,Patients with a history of depression need to be closely observed.
Dialogue: 0,0:05:47.75,0:05:50.43,Default,,0000,0000,0000,,Consider discontinuation if symptoms worsen.
Dialogue: 0,0:05:50.69,0:05:56.15,Default,,0000,0000,0000,,ENDOMETRIN should not be recommended for use with other vaginal products (such as antifungal products)
Dialogue: 0,0:05:56.15,0:06:00.23,Default,,0000,0000,0000,,as this may alter progesterone release and absorption from the vaginal insert.
Dialogue: 0,0:06:00.69,0:06:04.29,Default,,0000,0000,0000,,The most common adverse reactions reported (greater than 5%)
Dialogue: 0,0:06:04.29,0:06:07.26,Default,,0000,0000,0000,,were post-oocyte retrieval pain, abdominal pain,
Dialogue: 0,0:06:07.26,0:06:10.28,Default,,0000,0000,0000,,nausea, and ovarian hyperstimulation syndrome.
Dialogue: 0,0:06:10.70,0:06:13.57,Default,,0000,0000,0000,,Please see full prescribing information.