Treatment continuation and satisfaction in women using combined oral contraception with nomegestrol acetate and oestradiol: a multicentre, prospective cohort study (BOLERO).

OBJECTIVE: The aim of the study was to examine treatment continuation and satisfaction over 1 year among women receiving nomegestrol acetate (NOMAC)/oestradiol (E2) combined oral contraception (COC) in real-world clinical practice. METHODS: The 17ß-Estradiol and Nomegestrol Acetate (BOLERO) Study is an observational, non-interventional, prospective, multicentre cohort study of premenopausal women (aged 18-50 years) who received prescription NOMAC/E2 (2.5 mg/1.5 mg) for contraception during routine clinical practice. Assessments were carried out at enrolment and at 3, 6 and 12 months. Probability of treatment continuation through 12 months (primary outcome) was examined using Kaplan-Meier survival analysis. Secondary outcomes included treatment satisfaction, menstrual cycle-related symptoms, libido and adverse events (AEs). RESULTS: Of 298 enrolled women, 292 were evaluable. The probability of NOMAC/E2 continuation through 12 months was 73.7% (95% confidence interval [CI] 68.0%, 78.5%). Satisfaction with NOMAC/E2 increased from 56.9% (37/65) of women at initial evaluation to 89.2% (58/65) of women at 12 months. Physician ratings at 12 months showed satisfactory to very satisfactory in 84.0% (168/200) of women. Libido was not affected. Menstrual cycle-related symptoms significantly declined from enrolment (6.04 ± 4.32) to 3 months (3.25 ± 3.05) and 12 months (2.62 ± 2.74; p < .0001). Treatment-related AEs were reported by 38.7% (113/292) of women. CONCLUSION: The real-world experience of women receiving NOMAC/E2 indicated very good treatment continuation, high satisfaction and significantly improved menstrual cycle-related symptoms.

Changes in sexual function after medical or surgical termination of pregnancy.

INTRODUCTION: Voluntary termination of pregnancy (TOP) is a social issue; however, even if it is one of the most common procedures performed in the world, few studies evaluated sexual function changes after medical or surgical TOP. AIM: The aim of this study was to evaluate how first trimester TOP by either surgical (group 1) or medical procedure (group 2) affects sexual function. METHODS: This prospective observational study included 211 patients (132 in group 1 and 79 in group 2) who requested first trimester TOP between September 2010 and May 2012. Medical TOP (mifepristone and misoprostol) was offered to patients up to 49 days of gestation. Surgical TOP was performed up to 12 weeks. The Female Sexual Function Index (FSFI) was used to evaluate sexual function before TOP, after 1, 3, and 6 months from TOP. MAIN OUTCOME MEASURES: Changes in the FSFI values and number of sexual active patients after 1, 3, and 6 months from the TOP and the self-reported quality of sexual life at 6 months, with the two different procedures, were the main outcome measures. RESULTS: At 4-week follow-up, 23.6% of women in group 1 did not resume sexual intercourse compared with 5.4% of women in group 2 (P = 0.003). At 6 months, 3.3% of women in the group 1 and no women in the group 2 did not resume sexual intercourses (P = 0.123). Compared with women in group 2, those in group 1 had lower FSFI score and number of sexual intercourses at 1, 3, and 6 months follow-up (P < 0.001). CONCLUSIONS: This study shows that the number of sexually active women and the overall FSFI are reduced in women undergoing surgical TOP compared with those undergoing medical TOP. Counseling regarding sexual function changes should be included in the discussion of morbidity related to medical or surgical TOP.

Efficacy and acceptability of long-term norethindrone acetate for the treatment of rectovaginal endometriosis.

OBJECTIVE: To study the efficacy of long-term treatment with norethindrone acetate (NETA) in patients with rectovaginal endometriosis. STUDY DESIGN: This retrospective cohort study included 103 women with pain symptoms caused by rectovaginal endometriosis. Patients received NETA alone (2.5mg/day up to 5mg/day) for 5 years. Primary outcome was the degree of satisfaction with treatment after 5 years of progestin therapy. Secondary outcomes were the assessment of any variation in pain symptoms and the volumetric assessment of the disease by magnetic resonance imaging (MRI). RESULTS: Sixty-one women completed the 5-year follow-up (61/103, 59.2%) with 16 women withdrawing because of adverse effects (38.1%). Overall, 68.8% (42/61) of the women who completed the study were satisfied or very satisfied of this long term NETA treatment. This represents a 40.8% (42/103) of the patients enrolled. Intensity of chronic pelvic pain and deep dyspareunia significantly decreased during treatment (p<0.001 versus baseline at 1 and 5year). Dyschezia improved after 1-year respect to baseline (p=0.008) but remained stable between first and second year (p=0.409). At the end of 5 years treatment, a radiological partial response was observed in 33 patients (55.9%, n 33/59); a stable disease in 19 patients (32.2%, n 19/59). Seven women (7/59, 11.9%) displayed a volumetric increase of rectovaginal endometriosis under NETA treatment. CONCLUSION: Five-year therapy with NETA is safe and well tolerated by women with rectovaginal endometriosis. Due to its low cost and good pharmacological profile, it represents a good candidate for long-term treatment in this setting.

Second surgery for recurrent unilateral endometriomas and impact on ovarian reserve: a case-control study.

OBJECTIVE: To investigate the impact on ovarian reserve of second laparoscopic surgery for recurrent unilateral endometriomas. DESIGN: Case-control study. SETTING: University teaching hospital. PATIENT(S): This study included patients who underwent stripping of endometriomas (diameter ≥4 cm) and were followed-up at our institution. Case subjects had second surgery for recurrent unilateral endometriomas (n = 18); control subjects had no recurrence and no second surgery (n = 18). INTERVENTION(S): This case-control study was based on a retrospective analysis of a prospectively collected database including patients who underwent surgery for endometriomas at our institution. MAIN OUTCOME MEASURE(S): The primary outcome of the study was to assess the changes in antimüllerian hormone (AMH) levels in each study group and between the two study groups. The secondary outcomes of the study were to assess the changes in basal FSH, antral follicle count (AFC), and ovarian volume in each study group and between the two study groups. RESULT(S): In both study groups, primary surgery decreased AMH, increased basal FSH, and decreased the AFC of the operated ovary. Before second surgery, case subjects had AMH, basal FSH, and AFC similar to control subjects. After second surgery, case subjects had lower AMH, higher basal FSH, and lower AFC of the affected ovary than before surgery; the volume of the operated ovary was lower than that of the contralateral ovary. CONCLUSION(S): The laparoscopic stripping of recurrent ovarian endometriomas is associated with a high risk of ovarian reserve damage and ovarian failure. CLINICAL TRIAL REGISTRATION NUMBER: NCT02047838.