ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER
Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding. There is no evidence that the use of "natural" estrogens results in a different endometrial risk profile than synthetic estrogens at equivalent estrogen doses. (See WARNINGS, Malignant neoplasms, Endometrial cancer.)
CARDIOVASCULAR AND OTHER RISKS
Estrogens with and without progestins should not be used for the prevention of cardiovascular disease. (See WARNINGS, Cardiovascular disorders.)
The Women's Health Initiative (WHI) study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5 years of treatment with oral conjugated equine estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) relative to placebo. (See CLINICAL PHARMACOLOGY, Clinical Studies.)
Other doses of oral conjugated estrogens with medroxyprogesterone, and other combinations and dosage forms of estrogens and progestins were not studied in the WHI clinical trials and, in the absence of comparable data, these risks should be assumed to be similar. Because of these risks, estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.
Synthetic conjugated estrogens, A tablets contain a blend of nine (9) synthetic estrogenic substances. The estrogenic substances are sodium estrone sulfate, sodium equilin sulfate, sodium 17(alpha)-dihydroequilin sulfate, sodium 17(alpha)-estradiol sulfate, sodium 17(beta)-dihydroequilin sulfate, sodium 17(alpha)-dihydroequilenin sulfate, sodium 17(beta)-dihydroequilenin sulfate, sodium equilenin sulfate and sodium 17(beta)-estradiol sulfate.
Cenestin therapy is indicated for the:
Treatment of moderate-to-severe vasomotor symptoms associated with the menopause.
0.45 mg Cenestin
0.625 mg Cenestin
0.9 mg Cenestin
1.25 mg Cenestin
Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.
Published Studies Related to Synthetic Conjugated Estrogens
A randomized, multiple-dose parallel study to compare the pharmacokinetic parameters of synthetic conjugated estrogens, A, administered as oral tablet or vaginal cream. [2011.04]
OBJECTIVE: A randomized, parallel-design study was conducted to determine the pharmacokinetic profile of synthetic conjugated estrogens A (SCE-A) vaginal cream (0.625 mg SCE-A/g) when administered at intervals (1 g once daily for 7 d, then twice weekly) over a 27-day period as compared with the pharmacokinetic profile of 0.3 mg SCE-A tablets administered once daily orally for 27 days... CONCLUSIONS: After intravaginal application of SCE-A vaginal cream, absorption of estrogens was lower compared with absorption after oral administration. At steady state, the systemic exposure of equilin, estradiol, and estrone was significantly lower after twice-weekly administration of 1 g SCE-A vaginal cream compared with that achieved with an oral daily dose of a 0.3 mg SCE-A tablet. (c) 2011 by The North American Menopause Society
Protein-containing synthetic surfactant versus protein-free synthetic surfactant for the prevention and treatment of respiratory distress syndrome. [2009.10.07]
CONCLUSIONS: In the one trial comparing protein containing synthetic surfactants compared to protein free synthetic surfactant for the prevention of RDS, no statistically different clinical differences in death and chronic lung disease were noted. Clinical outcomes between the two groups were generally similar although the group receiving protein containing synthetic surfactants did have decreased incidence of respiratory distress syndrome. Further well designed studies comparing protein containing synthetic surfactant to the more widely used animal derived surfactant extracts are indicated.
Twice-weekly synthetic conjugated estrogens vaginal cream for the treatment of vaginal atrophy. [2009.07]
OBJECTIVE: The aim of this study was to evaluate low-dose synthetic conjugated estrogens A (SCE-A) cream administered twice weekly for the treatment of moderate to severe vulvovaginal atrophy (VVA) in a symptomatic postmenopausal population... CONCLUSIONS: A low dose (1 g = 0.625 mg) of SCE-A vaginal cream administered twice weekly was shown to be effective compared with placebo in treating VVA in postmenopausal women for the three coprimary efficacy measures of maturation index, pH, and severity of the MBS.
Randomized, multicenter, double-blind, placebo-controlled trial to evaluate the efficacy and safety of synthetic conjugated estrogens B for the treatment of vulvovaginal atrophy in healthy postmenopausal women. [2008.10]
OBJECTIVE: To evaluate the safety and efficacy of synthetic conjugated estrogens B (SCE-B; 0.3 mg/d) for 12 weeks in the treatment of vulvovaginal atrophy in symptomatic, postmenopausal women... Significant improvement was seen in vaginal maturation index, vaginal pH, and severity of MBS from baseline to the end of treatment.
A Randomised Study of Two Doses of Biosynthetic Human Growth Hormone on Final Height of Pubertal Children with Growth Hormone Deficiency. [2008.06.12]
Aims: To determine the effectiveness of different doses of r-hGH therapy during puberty in children with growth hormone deficiency (GHD). Methods: Randomized controlled trial of different doses of r-hGH therapy administered during puberty in 49 children with GHD...
Clinical Trials Related to Synthetic Conjugated Estrogens
Autologous Versus Synthetic Versus Biological Sling for Trans-Obturator Correction of Urinary Stress Incontinence [Recruiting]
The treatment of urinary stress incontinence with trans-obturator approach, know as
transobturatory tape (TOT), is a largely used sling-adopting procedures. The efficacy and
safety of this minimally invasive surgery have been demonstrated, also in comparison with
similar procedures, i. e transvaginal tape (TVT).
To date the results of TOT in terms of efficacy and safety described in literature mainly
refer to procedure in which synthetic materials are used, whereas few data regarding the use
of biological materials are available. Moreover, despite the well known benefits of the
available synthetic and eterologue kit, their use may be limited by the high cost of these
materials. At this proposal it can be suggested as alternative option the possibility to
perform the procedure using an autologous tissue, i. e. rectus fascia, and reusable
introductory needles. Based on these considerations the aim of this trial will be to compare
autologous, synthetic and biological mesh for TOT in women with urinary stress incontinence.
Impact of Nitrate Ingestion on Protein Synthesis [Not yet recruiting]
A diet rich in leafy green vegetables has been shown to reduce the risk of developing
chronic metabolic disease. The health benefits from these particular vegetables may be
attributed to their high nitrate content. Recent work suggests that dietary nitrate triggers
endogenous nitric oxide release, thereby stimulating vasodilation and improving muscle
perfusion in an insulin-independent manner. We hypothesize that in an insulin-resistant
state, nitrate co-ingestion will increase muscle perfusion, thereby improving post-prandial
delivery of nutrients to skeletal muscle tissue. Specifically, a more efficient delivery of
food derived amino acids will stimulate post-prandial muscle protein synthesis and, as such,
compensate for a blunted muscle protein synthetic response to food intake in the elderly.
This proposal will investigate the efficacy of nitrate co-ingestion as a means to augment
muscle protein synthesis in elderly, type 2 diabetes patients and may lead to a novel
therapy in the clinical care of type 2 diabetes patients.
Primary and Secondary Ventral Hernia Repair Using Long-term Resorbable Versus Non-resorbable Large Pore Synthetic Mesh. [Not yet recruiting]
Since abdominal wall hernia repair is currently performed with the use of a mesh, side
effects associated with the mesh are frequently reported during long term follow-up. These
side effects are related to shrinkage of the mesh, adhesions to the bowl, pain, and
inflammation of the skin and bowl. To reduce or prevent these effects, a fully resorbing
mesh has been developed, which provides sufficient support and strength to allow efficient
recovery of the abdominal wall, but also disappear from your body in three years time, so
that you no longer have any synthetic material in your body. Previous resorbing meshes also
disappeared but over a much shorter period of time, so that the hernia was insufficiently
healed, with recurrence as a result.
The TIGR™ mesh (the resorbable mesh used in the study) is in principle a synthetic mesh,
made of two commonly used polymers, however it will retain 50% of its initial strength after
six months. This in theory is enough to provide support of the collagen healing process
during the initial wound-healing phase, but also to support the transition of initial
collagen to functional collagen.
The aim of this study is to compare TIGR™ with large pore mesh used in the repair of the
anterior abdominal wall repair (incisional hernia, umbilical hernia, etc..Inguinal hernias
are not part of the study).
Therefore the patients will be divided into two groups, one group will be treated with a
resorbing mesh, the other group will be treated with a permanent mesh. Otherwise there will
be no difference in the medication or the surgical techniques used.
Biologic Mesh Versus Synthetic Mesh in Repair of Ventral Hernias [Recruiting]
This study will compare the safety, efficacy and cost effectiveness of a permanent synthetic
mesh versus a biologic prosthesis for the repair of ventral hernias in the setting of
The findings of this study will have a major impact on the field of hernia surgery as it
will provide objective guide to mesh selection, optimize surgical approaches and ultimately
maximize patient outcomes.
Protein Blends (Soy, Whey and Casein) for Muscle Synthesis [Recruiting]
Soy protein is a high quality, plant-based protein that is comparable to milk, meat and
eggs. Soy protein has a digestion rate (intermediate) compared to whey (fast) and casein
(slow). This intermediate rate may allow soy protein to have an extended window of muscle
protein synthesis that has not been monitored in previous studies. While most of the sports
nutrition "recovery" products are dairy-based protein blends (high in branched-chain amino
acids), soy protein offers additional benefits that can make an important contribution to
these types of sports nutrition products. Soy protein contains approximately 300% more
arginine and 30% more glutamine compared to whey protein and these two amino acids may bring
additional benefits (immunity and hydration, respectively) to athletes. A "blend" of
high-quality proteins (soy and dairy) may be the optimal sports nutrition product for
athletes to consume following training.
Page last updated: 2011-12-09