Efficacy,safety, and tolerability of a levonorgestrel/ethinyl estradiol transdermal delivery system: Phase 3 clinical trial results

ObjectiveTo assess the contraceptive efficacy, safety, and tolerability of a contraceptive transdermal delivery system, (TDS; TWIRLA^?) containing levonorgestrel (LNG) and ethinyl estradiol (EE).Study designThis single-arm, open-label, multicenter, 1-year (13 cycle), phase 3 study enrolled sexually active women ≥18 years old at risk for pregnancy irrespective of body mass index (BMI). Women used patches in 28-day cycles (3 consecutive administrations of 7-day patches followed by 7 days off-treatment/patch-free week). We assessed contraceptive efficacy by the Pearl Index (PI) in women 18 to 35 years, excluding cycles without intercourse or when other contraceptive methods were used.ResultsThe study enrolled 2032 demographically diverse women in the US, of which 35.3% had a BMI ≥30 kg/m². In the primary efficacy analysis, the PI (95% confidence interval) was 5.8 (4.5–7.2) pregnancies per 100 woman-years. PIs trended higher as BMI increased; the PI was 4.3 (2.9–5.8) in women with BMI <30 kg/m² and 8.6 (5.8–11.5) in women with BMI ≥30 kg/m². Hormone-related treatment-emergent adverse events included nausea (4.1%) and headache (3.6%); 11% of women discontinued due to adverse events. Four women (all with BMIs ≥30 kg/m²) reported thromboembolic events considered related to treatment.ConclusionsThe low-dose LNG/EE TDS was effective in preventing pregnancy in a population of women representative of US demographics. Efficacy was reduced in women with BMI ≥30 kg/m². The TDS safety and tolerability profile was consistent with other similar dose combined hormonal contraceptives. Results of this phase 3 study supported the US Food and Drug Administration approval of TWIRLA^? for prevention of pregnancy in women with BMI <30 kg/m².ImplicationsTDS (120 µg/day levonorgestrel and 30 µg/day ethinyl estradiol) is an effective, low-dose transdermal contraceptive patch with favorable tolerability profile approved for prevention of pregnancy in women with BMI <30 kg/m². TDS has reduced effectiveness in women with BMI ≥30 kg/m².     

Tailored hormonal therapy in secretory adrenocortical cancer

Mitotane is often considered the front-line hormonal therapyof adrenocortical carcinoma (ACC). An illustrative case concerningthis issue and the rationale to ponder other alternatives isreported. A 69 year-old woman, diagnosed with ACC was admittedwith hypertensive crisis, supraventricular tachycardia, congestiveheart-failure, diarrhoea and rabdomyolisis. Two years earlier,she had undergone     

Factors Associated with Sexually Transmitted Infections Among Young Ghanaian Women

Objective

To identify factors associated with a history of sexually transmitted infections in Ghanaian women 15 – 24 years.

Design

The study was a cross-sectional data analysis of 1280 sexually experienced females from the 2003 Ghana Demographic Health Survey. Using chi square and t-test, those with a history or symptoms of STI were compared with those denying such a history on demographic, individual and partner level variables. Significant variables were entered into logistic regression to identify variables associated with STI.

Results

The STI group comprised 12% of the study population. Compared to those denying a history of STI, the STI group was less likely to know where to get condoms (37% vs 23%, p=.001) but more likely to use a condom at their last sexual encounter (27% vs 17%, p=.003). Women in the STI group were significantly less likely to discuss family planning with their partners but more likely to have 2 or more partners in the preceding 12 months. Logistic regression showed that factors associated with STI among sexually active Ghanaian female youth included not knowing where to get condoms and not discussing family planning with partner.

Conclusion

Majority of sexually experienced Ghanaian female youth do not know where to get condoms. Lack of knowledge of source of condoms was identified as a risk factor for STI for these women.     

Hepatitis B and C in doctors and dentists in Nigeria

We surveyed a random sample (n = 75) of doctors and dentists at University College Hospital, Ibadan, Nigeria. They were offered anonymous testing for hepatitis B surface antigen (HBsAg), hepatitis Be antigen (HBeAG), antibodies to hepatitis B core antigen (anti-HBc) and to hepatitis C virus (anti-HCV), by enzyme immunoassay. The results suggest a high prevalence of hepatitis B virus (HBV) with a high potential of transmissibility, as well as a high prevalence of HCV infection. The majority of the doctors and dentists use universal precaution for protection against viral hepatitis on < 50% of the occasions when they carry out procedures on their patients. Infection with HBV was associated with type of specialty (surgeons, dentists) and lack of HBV vaccination (p < 0.05). After logistic regression, these factors were independently associated with HBV infection (p < 0.05). Sixty (80%) had not received prior HBV vaccination. Unvaccinated personnel were more likely to be surgeons, dentists, < 37 years of age, and have fewer years of professional activity (p < 0.05). After logistic regression, only fewer years of professional activity remained independently associated with lack of vaccination (p < 0.05). To reduce the occupational exposure of HBV, universal precautions must be rigorously adhered to when the doctors and dentists carry out procedures on their patients, and all health-care workers should be vaccinated with HBV vaccine and the HCV vaccine, when it becomes available.