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Crinone (Progesterone Vaginal) - Summary



Crinone® (progesterone gel) is a bioadhesive vaginal gel containing micronized progesterone in an emulsion system, which is contained in single use, one piece polyethylene vaginal applicators. The carrier vehicle is an oil in water emulsion containing the water swellable, but insoluble polymer, polycarbophil. The progesterone is partially soluble in both the oil and water phase of the vehicle, with the majority of the progesterone existing as a suspension. Physically, Crinone® has the appearance of a soft, white to off-white gel. The active ingredient, progesterone, is present in either a 4% or an 8% concentration (w/w).

Assisted Reproductive Technology

Crinone® 8% is indicated for progesterone supplementation or replacement as part of an Assisted Reproductive Technology ("ART") treatment for infertile women with progesterone deficiency.

Secondary Amenorrhea

Crinone® 4% is indicated for the treatment of secondary amenorrhea. Crinone® 8% is indicated for use in women who have failed to respond to treatment with Crinone® 4%.

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Published Studies Related to Crinone (Progesterone Vaginal)

[Impacts on the duration of vaginal bleeding and the levels of serum estradiol (E2) and progesterone (P) for patients of midtrimester induction of labor treated with moxibustion at Guanyuan (CV 4) and Shenque (CV 8)]. [2011.09]
OBJECTIVE: To verify the efficacy of moxibustion at Guanyuan (CV 4) and Shenque (CV 8) on the duration of vaginal bleeding for patients with midtrimester induction of labor and explore its mechanism... CONCLUSION: Moxibustion at Guanyuan (CV 4) and Shenque (CV 8) may shorten the duration of vaginal bleeding for patients with midtrimester induction of labor. Probably through the increase of serum E2 level and the decrease of P level, the uterine contraction is effectively enhanced and the excretion of placental villi and deciduas is promoted. As a result, endometrial repair occurs rapidly.

Vaginal micronized progesterone and risk of preterm delivery in high-risk twin pregnancies: secondary analysis of a placebo-controlled randomized trial and meta-analysis. [2011.09]
OBJECTIVES: Progesterone treatment reduces the risk of preterm delivery in high-risk singleton pregnancies. Our aim was to evaluate the preventive effect of vaginal progesterone in high-risk twins... CONCLUSION: In high-risk twin pregnancies, progesterone treatment does not significantly improve outcome. Copyright (c) 2011 ISUOG. Published by John Wiley & Sons, Ltd.

Prevention of preterm delivery in twin gestations (PREDICT): a multicenter, randomized, placebo-controlled trial on the effect of vaginal micronized progesterone. [2011.09]
OBJECTIVE: Studies on high-risk singleton gestations have shown a preventive effect of progesterone treatment on preterm delivery. This study was conducted to investigate the preventive effect of vaginal micronized progesterone in a large population of twin gestations... CONCLUSION: Progesterone treatment did not prevent preterm delivery in twin gestations. There were no harmful effects to fetuses and infants of maternal progesterone treatment. Copyright (c) 2011 ISUOG. Published by John Wiley & Sons, Ltd.

Vaginal progesterone reduces the rate of preterm birth in women with a sonographic short cervix: a multicenter, randomized, double-blind, placebo-controlled trial. [2011.07]
OBJECTIVES: Women with a sonographic short cervix in the mid-trimester are at increased risk for preterm delivery. This study was undertaken to determine the efficacy and safety of using micronized vaginal progesterone gel to reduce the risk of preterm birth and associated neonatal complications in women with a sonographic short cervix... CONCLUSIONS: The administration of vaginal progesterone gel to women with a sonographic short cervix in the mid-trimester is associated with a 45% reduction in the rate of preterm birth before 33 weeks of gestation and with improved neonatal outcome. Copyright (c) 2011 ISUOG. Published by John Wiley & Sons, Ltd.

Comparison of oral dydrogestrone with progesterone gel and micronized progesterone for luteal support in 1,373 women undergoing in vitro fertilization: a randomized clinical study. [2011.05]
OBJECTIVE: To compare the efficacy of oral dydrogesterone with that of micronized vaginal P gel and micronized P capsule for luteal supplementation...

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Clinical Trials Related to Crinone (Progesterone Vaginal)

Multi-Center, Randomized, Open-Label, Parallel Group Study of a Vaginal Micronized Progesterone Tablet (Endometrin) Compared to Crinone 8% Vaginal Gel in Female Patients Undergoing In-Vitro Fertilization (IVF) [Completed]
This multicenter, randomized, open-label study will be performed in approximately 990 healthy females undergoing IVF. Each study center will follow their study center standard practice for IVF unless otherwise noted in this protocol. The study centers will be provided with the medications for down regulation, stimulation and ovulation induction. The subjects will be randomized to study medication on the day of oocyte retrieval or the day following and will continue treatment for up to 10 weeks. The subjects with a confirmed pregnancy will be required to return to the clinic several times during the course of the 10 week treatment period for serum pregnancy tests and transvaginal ultrasounds to monitor the pregnancy.

Evaluating the Roles of Estrogen and Progesterone in Heart Metabolism [Completed]
Estrogen and progesterone are two main female sex hormones. When a woman goes through menopause, the body's production of estrogen and progesterone significantly decreases. Recent studies have shown that the breakdown of fatty acids in cardiac muscle is important in maintaining a healthy heart, and that estrogen may enhance this process. Also, cardiovascular disease (CVD) occurs more frequently in postmenopausal women than in premenopausal women. This study will determine in postmenopausal women whether estrogen increases the heart's ability to use fats as energy and whether progesterone decreases this effect.

Artificial Endometrial Preparation for Frozen Thawed Embryo Transfer Applying Either Endometrin or Utrogestan [Suspended]
The transfer of frozen-thawed embryos can be performed in a natural ovulatory cycle or in a hormonally manipulated cycle with a comparable pregnancy rate of 15%-20% per ET. When a hormonally modulated ET cycle is scheduled,an artificial endometrial preparation is carried out using estrogen stimulation followed by a concomitant progesterone treatment. Two progestative drugs are currently used in conventional IVF treatment, Utrogetan and Endometrin. Although Endometrin has been be efficiently used to support the luteal phase after embryo transfer in IVF cycles, currently, there is no study that assess its efficacy for clinical use in frozen-thawed ET cycles. The present study aims to compare the outcome of frozen thawed ET cycles when either Endometrin or Utrogestan are used as the progestative substitution in an artificially prepared endometrium.

Comparing IM vs. Vaginal Progesterone for Pre-term Birth [Recruiting]
This is a randomized controlled trial comparing weekly intramuscular injection of 17 alpha hydroxylprogesterone caproate with daily vaginal progesterone in women with singleton pregnancies and history of prior spontaneous preterm birth in terms of maternal, fetal and neonatal outcomes.

Our aim is to assess the effects on maternal, fetal and neonatal outcomes of antenatal progesterone administered intramuscularly versus vaginally in women with singleton pregnancy and a history of prior preterm birth.

Vaginal Progesterone as a Treatment for Women Active Preterm Labor [Recruiting]
The purpose of this study is to compare how well vaginal progesterone works delaying the time to delivery in women with preterm labor compared to placebo. The study will also compare the effect of vaginal progesterone on neonatal outcomes, rate of spontaneous preterm delivery, cervical length and biomarkers of preterm delivery in women diagnosed with and treated with medication to stop preterm labor.

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Page last updated: 2011-12-09

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