BOX WARNING
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.
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SUMMARY
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:
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Treatment of moderate-to-severe vasomotor symptoms associated with the menopause.
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0.45 mg Cenestin
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0.625 mg Cenestin
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0.9 mg Cenestin
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1.25 mg Cenestin
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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.
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NEWS HIGHLIGHTSMedia Articles Related to Synthetic Conjugated Estrogens
Hormone Replacement Therapy Decreases Mortality In Younger Postmenopausal Woman
Source: Cardiovascular / Cardiology News From Medical News Today [2009.10.29]
Hormone replacement therapy (HRT) to treat menopausal estrogen deficiency has been in widespread use for over 60 years. Several observational studies over the years showed that HRT use by younger postmenopausal women was associated with a significant reduction in total mortality; available evidence supported the routine use of HRT to increase longevity in postmenopausal women.
AACE Issues New Medical Guidelines For Proper And Ethical Use Of Growth Hormone
Source: Endocrinology News From Medical News Today [2009.11.04]
The American Association of Clinical Endocrinologists (AACE) released new medical guidelines for the accurate diagnosis and effective ethical treatment of growth hormone deficiency in affected patients. Growth hormone replacement therapy has proven useful for children and adults with scientifically proven growth hormone deficiency.
Published Studies Related to Synthetic Conjugated Estrogens
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 outcomes after treatment of intra-bony defects with an EMD/synthetic bone graft or EMD alone: a multicentre randomized-controlled clinical trial. [2008.03.12]
Objectives: Comparison of the outcomes of a combination of an enamel matrix derivative and a synthetic bone graft (EMD/SBC) with EMD alone in wide intra-bony defects. Material and Methods: Seventy-three patients with chronic periodontitis were recruited in five centres in Germany.Conclusion: The results of the present study showed similar clinical outcomes following both treatment modalities.
Clinical Trials Related to Synthetic Conjugated Estrogens
Synthetic Vaccine in Patients With Chronic Myeloid Leukemia and Minimal Residual Disease [Active, not recruiting]
Primary Objective:
1. To evaluate the anti-leukemic effects of vaccination with CML breakpoint peptides as
measured by a one-log decrease in circulating BCR-ABL transcripts using reverse transcription
polymerase chain reaction (RT-PCR).
Secondary Objectives:
1. To evaluate the percentage of patients who become RT-PCR negative for BCR-ABL
transcripts during the study period.
2. To determine whether responses in patients with B3A2 versus B2A2 junctions, immunized
with junction-specific peptide vaccines, differ.
3. To evaluate the immunologic responses to a vaccine containing native and synthetic CML
peptides over 1 year.
4. To determine whether responses to peptide vaccine correlate with immunologic responses.
5. To determine whether responses to peptide vaccine correlate with specific human
leukocyte antigen (HLA) types.
6. To evaluate the safety of a vaccine containing native and synthetic CML peptides over 1
year treatment.
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.
Safety and Efficacy of Synthetic Human Secretin-Enhanced MRCP in Subjects With Abnormalities of the Pancreas [Enrolling by invitation]
The purpose of this study is to evaluate the safety and effectiveness of RG1068 (synthetic
human secretin) with MRCP in subjects with abnormalities of the pancreas.
Effect of Nutrition on Muscle Protein Synthesis [Not yet recruiting]
The present proposal is designed to examine the effect of carbohydrate and protein
co-ingestion on muscle protein synthesis during endurance type exercise activities. We
hypothesize that muscle protein synthesis is higher when protein is co-ingested during
exercise.
Subcuticular Suture Versus Synthetic Glue in Thyroidectomy Incision [Recruiting]
The aim of this study is to compare aesthetic results of two different type of sutures
(subcuticular versus synthetic glue) in post-thyroidectomy incisions. It is a randomized
clinical trial (single blinded) designed as a superiority study, since in the authors'
hypotheses glue can give better results compared with subcuticular suture in this particular
district. Secondary objective is to investigate if other factors (like the use of cold/warm
blade, the sex, the presence of diabetes, the lenght of incision) can influence aesthetic
results.
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