The study demonstrated that NuvaRing(®) is a highly effective contraceptive method with an excellent cycle control. It is well tolerated and accepted by Indian women.

Objective To determine the influence of ''structured contraception counseling'' on Indian women's selection of contraceptive methods.Methods Women (C18 and B40 years) requesting contraception were enrolled at 36 sites. ''Structured contraception counseling'' was provided by a health care professional on the available contraceptive methods. 123Questionnaires on the women's pre-and post-counseling contraceptive choice, her perceptions, and the reasons behind her post-counseling decision were filled. Results Significant reductions were observed in the proportion of women who were indecisive (n = 260; 31.5 % pre-counseling vs. n = 30; 3.6 %, post-counseling [P \ 0.001]) and women opting for non-hormonal method (24.6 % pre-counseling vs. 6.8 % post-counseling, [P \ 0.001]). Of all the women counseled (n = 825), 89.6 % (739/825) of women chose a hormonal contraceptive method. There were significant difference (P \ 0.001) in the women's choice of contraceptive in the pre-and post-counseling sessions, respectively (combined oral contraceptive: 30.8 vs. 40.7 %; vaginal ring: 1.8 vs. 14.1 %; progestogen only pills: 1.6 vs. 7.9 %; injectabledepot medroxyprogesterone acetate: 5.9 vs. 13.6 %; levonorgestrel-intrauterine system: 3.8 vs. 13.3 %). Conclusions Structured contraception counseling using standardized protocol and aids resulted in a significant increase in the selection of modern contraceptive methods. Post-counseling majority of women opted for hormonal methods with an increase in selection of pills and newer alternatives.

Objective: To evaluate the opinions of Indian clinical experts and aid in clinical choices for the optimal use of vildagliptin-dapagliflozin fixed-dose combination (FDC) for treating type 2 diabetes (T2D) in Indian patients. Methods: The virtual round table meetings (RTMs) were conducted with healthcare professionals (HCPs) across India. A questionnaire that highlighted the role of vildagliptin-dapagliflozin FDC in treating T2D and determining the correct patient profile was created. The experts held the questionnaire discussion, and their comments were documented. The collected data were evaluated and categorized into four grades: Level A, very strong (≥80% responses); Level B, strong (≥50-79% responses); Level C, moderate (25-49% responses); Level D, neutral/no consensus (<25% responses). Results: More than 200 HCPs participated in 15 RTMs held between July 15 and October 22, 2022. With a consensus level A (Very strong), HCPs believed that vildagliptin-dapagliflozin FDC is an attractive option and suitable for a wide range of Indian T2D patient profiles, including those with atherosclerotic cardiovascular disease (ASCVD), those with a history of heart failure, older and obese individuals. The experts regarded vildagliptin-dapagliflozin FDC as the first-line treatment for T2D patients who were obese and hypertensive, with a consensus level of C (Moderate). Vildagliptin-dapagliflozin FDC was recommended as second-line treatment for obese and hypertensive T2D patients who are uncontrolled on metformin by experts with consensus level B (Strong). The clinical experts at consensus level B (Strong) agreed that T2D patients taking two oral antidiabetic drugs (OADs) and uncontrolled if HbA1c > 8% might be suitable candidates for initiating vildagliptin-dapagliflozin FDCs. Conclusion: Based on the present expert opinion-based consensus, most clinical experts believe that vildagliptin – dapagliflozin FDC is an appealing treatment option for a broad range of Indian T2D patients. Nevertheless, more multicentric studies are needed to support these recommendations.

CONTEXT:Infertility treatment involves a considerable amount of physical and psychological burden which may impact the outcome.AIM:The objective was to understand the amount of physical and psychological burden in women undergoing their first in vitro fertilization (IVF)/intra cytoplasmic sperm injection (ICSI) cycles.SETTING AND DESIGN:Multi-center, prospective, parallel, observational study.MATERIALS AND METHODS:The study was conducted across 12 IVF centers in India. A total of 692 women undergoing controlled ovarian stimulation as a part of the first cycle IVF/ICSI completed the trial. Women were recruited in 2 groups based on type of treatment (Group A - gonadotropin-releasing hormone [GnRH] antagonist; Group B - GnRH agonist) and were asked to fill questionnaires during the 2 treatment visits.RESULTS:The mean changes between Visit 1 (baseline) and Visit 2 in anxiety and depression (Hospital Anxiety and Depression Scale) scores in Group A for anxiety and depression were −0.5 (3.67), −0.1 (3.57) respectively and for Group B were −0.4 (3.68), 0.1 (3.67) respectively, which was not statistically significant. In Group A, the mean (±standard deviation [SD]) Hopkins Symptom Check List (HSCL) score was 17.9 (±5.17) in visit 1 and 19.1 (±5.45) Visit 2. The change between visits was 1.1 (P < 0.0001) with higher score reflecting higher somatic distress symptoms. In Group B, the mean (±SD) HSCL score was 18.2 (±5.19) in Visit 1 and 18.8 (±5.23) in visit 2. The change between visits was 0.6 (P < 0.0014). The difference of the mean change in physical burden between Group A and Group B was not statistically significant.CONCLUSION:A significant impact in both treatment protocols with respect to the physical burden was found between Visit 1 and Visit 2 but no difference in physical or psychological burden between the two treatment groups was observed.

Carbamazepine is a first-line antiepileptic drug (AED) used for the treatment of partial and tonic-clonic seizures. We conducted an open label, balanced, randomized, two-treatment, two-sequence, four-period, single oral dose, full-replicate crossover study to assess and compare the  bioequivalence of  test  product  Carbamazepine extended release tablets USP 400 mg with reference  product Tegretol®-XR 400 mg (Carbamazepine extended release tablets), respectively in  healthy subjects under fasting and fed conditions. Blood samples were collected pre-dose and at regular intervals post-dose up to 240.00 hours. The plasma concentration was analyzed by a validated LC-MS/MS method and the reference-scaled and the unscaled procedure was used to determine bioequivalence for the pharmacokinetics parameters, Cmax, AUC0–t, AUC0-inf, Tmax, T½, Kel and AUC extrapolated was calculated. The results showed that the geometric mean ratios of Cmax, AUC0–t and AUC0-inf were 113.04%, 108.33% and 108.15% respectively, in the fasting conditions and 113.99%, 110.13% and 111.41%, respectively, in the fed conditions and the 90% confidence intervals were all within the range of 80.00% to 125.00%. It can be concluded from the result that the test product Carbamazepine extended release tablets based on osmotic release system (OROS) are bioequivalent to the reference product Tegretol®-XR tablets. Keywords:  Bioequivalence, Carbamazepine, Sodium Channel Modulators and Epilepsy