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.
Outcome Comparison of Allograft and Synthetic Bone Substitute in High Tibial Osteotomy [Recruiting]
This study is conducted to determine whether a new synthetic bone substitute is better than
allogenic bone graft for addressing bone defect in medial open wedge high tibial osteotomy
in terms of postoperative pain, postoperative bleeding, operation time and bone healing. The
investigators hypothesized the new synthetic bone substitute would bring better outcomes in
the outcome variables mentioned above.
A Clinical Trial to Evaluate the Safety and Efficacy of DR-2041(Synthetic Conjugated Estrogens, A) for Treatment of Vulvovaginal Atrophy [Completed]
This is a four-arm, randomized, double-blind, parallel group, placebo-controlled study to
compare the effects of two doses of DR-2041(Synthetic Conjugated Estrogens, A) Vaginal Cream
on vulvovaginal atrophy in postmenopausal women with or without a hysterectomy and/or
Safety and Immunogenicity of a Personalized Synthetic Long Peptide Breast Cancer Vaccine Strategy in Patients With Persistent Triple-Negative Breast Cancer Following Neoadjuvant Chemotherapy [Not yet recruiting]
The most important consideration in the design of this clinical trial is to ensure the safe
translation of the personalized synthetic long peptide vaccine strategy. The Food and Drug
Administration (FDA) dictates that initial studies of biologic therapies be performed in
such a way that there is a balance between the potential risks and benefits in individual
patients. Consistent with these recommendations, the investigators will target patients with
triple-negative breast cancer who do not have a pathologic complete response after
neoadjuvant chemotherapy. These patients typically have no gross evidence of disease
following standard of care therapy (neoadjuvant chemotherapy, surgery and radiation therapy)
but are at extremely high-risk for disease recurrence. Targeting this patient population
provides a window-of-opportunity to design and manufacture the personalized cancer vaccines,
maximizes the potential benefit from the vaccine as the regulatory networks associated with
metastatic disease are not present, and balances risk in this patient population with
extremely high risk for disease recurrence but no other treatment options.
Synthetic Mesh Materials In Sling Surgery [Completed]
The purpose of this study is to determine the clinical results contributions to surgical
success,and complications of mixed type of mesh materials as well as prolen mesh materials
in sling surgery in a 3 year follow-up the first time in literature.
Page last updated: 2011-12-09