CRINONE 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.
Crinone® 8% is indicated for progesterone supplementation or replacement as part of an Assisted Reproductive Technology ("ART") treatment for infertile women with progesterone deficiency.
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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NEWS HIGHLIGHTSMedia Articles Related to Crinone (Progesterone Vaginal)
"CRINONE(R) 8% (progesterone Vaginal Gel) As Effective As Hormone Injections During IVF" Is Medscape's "Top News" From The ASRM 65th Annual Meeting
Source: Fertility News From Medical News Today [2009.11.12]
In their American Society of Reproductive Medicine (ASRM) conference wrap-up, Medscape highlighted the article published by them on October 27, 2009, which summarized the results from the largest prospective, randomized clinical study to compare vaginal progesterone to intramuscular progesterone injections (IM progesterone) for luteal support in infertility treatment.
Published Studies Related to Crinone (Progesterone Vaginal)
Effects of nonoral estradiol-micronized progesterone or low-dose oral estradiol-drospirenone therapy on metabolic variables and markers of endothelial function in early postmenopause. [2009.08]
OBJECTIVE: To evaluate the effects of low-dose oral hormone therapy and nonoral hormone therapy on endothelial function markers and on anthropometric, metabolic, and hormonal variables in early postmenopausal women... CONCLUSION(S): Neither treatment induced deleterious effects in the short term on variables related to cardiovascular risk in early postmenopausal women.
Progesterone for the prevention of preterm birth in twin pregnancy (STOPPIT): a randomised, double-blind, placebo-controlled study and meta-analysis. [2009.06.13]
BACKGROUND: Women with twin pregnancy are at high risk for spontaneous preterm delivery. Progesterone seems to be effective in reducing preterm birth in selected high-risk singleton pregnancies, albeit with no significant reduction in perinatal mortality and little evidence of neonatal benefit. We investigated the use of progesterone for prevention of preterm birth in twin pregnancy... INTERPRETATION: Progesterone, administered vaginally, does not prevent preterm birth in women with twin pregnancy. FUNDING: Chief Scientist Office of the Scottish Government Health Directorate.
Fixed-time AI pregnancy rate following insemination with frozen-thawed or fresh-extended semen in progesterone supplemented CO-Synch protocol in beef cows. [2009.04.15]
The objective of this study was to compare fixed-time AI pregnancy rate in Angus crossbred beef cows inseminated with frozen-thawed or fresh-extended semen. Two ejaculates from each of two Angus bulls were collected by artificial vagina and pooled for each bull... In conclusion, commercial beef cows inseminated with fresh-extended semen (3 x 10(6)sperm/straw) yielded comparable pregnancy rates to conventional frozen-thawed semen in a progesterone supplemented, CO-Synch fixed-time AI synchronization protocol and may provide an alternate to frozen semen for more efficient utilization of superior genetics.
Progesterone after previous preterm birth for prevention of neonatal respiratory distress syndrome (PROGRESS): a randomised controlled trial. [2009.02.24]
BACKGROUND: Neonatal respiratory distress syndrome, as a consequence of preterm birth, is a major cause of early mortality and morbidity during infancy and childhood...
Implanon versus medroxyprogesterone acetate: effects on pain scores in patients with symptomatic endometriosis--a pilot study. [2009.01]
BACKGROUND: Implanon has been reported to be effective in the treatment of dysmenorrhea. We compared the therapeutic efficacies of depot medroxyprogesterone acetate (DMPA) and Implanon with regard to pain relief in women with endometriosis... CONCLUSION: Concerning pain relief, the therapeutic efficacy of the contraceptive implant Implanon is not inferior to that of DMPA in symptomatic endometriosis.
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.
Progesterone Reduces Wakefulness in Sleep EEG and Has no Effect on Cognition in Healthy Postmenopausal Women [Completed]
Sleep is impaired in postmenopausal women (difficulty falling asleep, frequent awakenings).
Progesterone prompted benzodiazepine-like effects on sleep EEG in young normal male
subjects.
Aim of this study was to test if replacement therapy with progesterone improves sleep after
menopause.
Design, Setting, and Participants: A double blind cross-over design study with 2 treatment
intervals of 21 days duration separated by a 2 weeks washout was performed. A oral dose of
300mg micronized progesterone was given each for 21 days. At the beginning and the end of the
two intervals a sleep EEG was recorded and cognitive performance was assessed in 10 healthy
postmenopausal women (age: 54-70 yrs).
Comparison of Crinone 8% Intravaginal Gel and IM Progesterone Supplementation for In Vitro Fertilization [Recruiting]
The goal of this research study is to compare the pregnancy rates for two different types of
progesterone supplementation after in-vitro fertilization (IVF).
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