Diana Mansour

The effects of Implanon on menstrual bleeding patterns.

Objectives To evaluate an integrated analysis of bleeding patterns associated with use of the subdermal contraceptive implant Implanon® (etonogestrel, Organon, part of Schering-Plough) and to provide physician guidance to optimize patient counselling. Methods Data from 11 clinical trials were reviewed (N = 923). Assessments included bleeding-spotting records, dysmenorrhoea, and patient-perceived reasons for discontinuation. Bleeding patterns were analysed via reference period (RP) analyses. Results Implanon® use was associated with the following bleeding irregularities: amenorrhoea (22.2%) and infrequent (33.6%), frequent (6.7%), and/or prolonged bleeding (17.7%). In 75% of RPs, bleeding-spotting days were fewer than or comparable to those observed during the natural cycle, but they occurred at unpredictable intervals. The bleeding pattern experienced during the initial phase predicted future patterns for the majority of women. The group of women with favourable bleeding patterns during the first three months tended to continue with this pattern throughout the first two years of use, whereas the group with unfavourable initial patterns had at least a 50% chance that the pattern would improve. Only 11.3% of patients discontinued owing to bleeding irregularities, mainly because of prolonged flow and frequent irregular bleeding. Most women (77%) who had baseline dysmenorrhoea experienced complete resolution of symptoms. Conclusion Implanon® use is associated with an unpredictable bleeding pattern, which includes amenorrhoea and infrequent, frequent, and/or prolonged bleeding. The bleeding pattern experienced during the first three months is broadly predictive of future bleeding patterns for many women. Effective preinsertion counselling on the possible changes in bleeding patterns may improve continuation rates.

Efficacy of contraceptive methods: A review of the literature

Objectives To provide a comprehensive and objective summary of contraceptive failure rates for a variety of methods based on a systematic review of the literature. Methods Medline and Embase were searched using the Ovid interface from January 1990 to February 2008, as well as the reference lists of published articles, to identify studies reporting contraceptive efficacy as a Pearl Index or life-table estimate. Reports that recruited less than 400 subjects per study group and those covering less than six cycles/six months were excluded. In addition, unlicensed products or those not internationally available, emergency contraception, and vasectomy studies were excluded. Results Information was identified and extracted from 139 studies. One-year Pearl Indices reported for short-acting user-dependent hormonal methods were generally less than 2.5. Gross life-table rates for long-acting hormonal methods (implants and the levonorgestrel releasing-intrauterine system [LNG-IUS]) generally ranged between 0–0.6 per 100 at one year, but wider ranges (0.1–1.5 per 100) were observed for the copper intrauterine devices (0.1–1.4 per 100 for Cu-IUDs with surface area ≥300 mm2 and 0.6–1.5 per 100 for those with surface area <300 mm2). Barrier and natural methods were the least effective. Conclusions Our review broadly confirms the hierarchy of contraceptive effectiveness in descending order as: (1) female sterilisation, long-acting hormonal contraceptives (LNG-IUS and implants); (2) Cu-IUDs with ≥300 mm2 surface area; (3) Cu-IUDs with <300 mm2 surface area and short-acting hormonal contraceptives (injectables, oral contraceptives, the patch and vaginal ring), and (4) barrier methods and natural methods.

Bleeding pattern and cycle control with an estradiol-based oral contraceptive: a seven-cycle, randomized comparative trial of estradiol valerate/dienogest and ethinyl estradiol/levonorgestrel

BACKGROUND This study compared the bleeding pattern, cycle control and safety of an oral contraceptive (OC) comprising estradiol valerate/dienogest (E2V/DNG; administered using a dynamic dosing regimen) with a monophasic OC containing ethinyl estradiol 20 mcg/levonorgestrel 100 mcg (EE/LNG). E2V releases estradiol (E2), which is identical to endogenously produced 17beta-estradiol. STUDY DESIGN This was a randomized, multicenter, double-blind, double-dummy trial lasting seven cycles in healthy women aged 18-50 years. RESULTS Overall, 798 women were randomized and received allocated treatment (399 per group). There were significantly fewer bleeding/spotting days reported by women who received E2V/DNG than those who received EE/LNG [17.3+/-10.4 vs. 21.5+/-8.6, respectively, p<.0001, Reference Period 1 (Days 1-90); and 13.4+/-9.vs. 15.9+/-7.1, respectively, p<.0001, Reference Period 2 (Days 91-180)]. Through Cycles 1-7, the occurrence of scheduled withdrawal bleeding per cycle was 77.7-83.2% with E2V/DNG and 89.5-93.8% with EE/LNG (p<.0001 per cycle). The duration and intensity of scheduled withdrawal bleeding were reduced with E2V/DNG vs. EE/LNG. The incidence of intracyclic bleeding was similar with E2V/DNG (10.5%-18.6%) and EE/LNG (9.9%-17.1%) (p>.05 per cycle). No unintended pregnancies occurred with E2V/DNG, but there was one unintended pregnancy with EE/LNG. Adverse drug reactions occurred in 10.0% and 8.5% of women taking E2V/DNG and EE/LNG, respectively. Overall, 79.4% of women were satisfied with E2V/DNG and 79.9% with EE/LNG. CONCLUSIONS A novel OC composed of E2V/DNG is associated with an acceptable bleeding profile that is comparable to that of an EE-containing OC.

Efficacy and tolerability of a monophasic combined oral contraceptive containing nomegestrol acetate and 17β-oestradiol in a 24/4 regimen, in comparison to an oral contraceptive containing ethinylestradiol and drospirenone in a 21/7 regimen

ABSTRACT Objectives The primary objective was to assess the efficacy, cycle control and tolerability of a monophasic combined oral contraceptive (COC) containing nomegestrol acetate (NOMAC) and 17β-oestradiol (E2). Effects on acne were evaluated as a secondary objective. Results were compared to those of a COC containing drospirenone (DRSP) and ethinylestradiol (EE). Methods Women (aged 18–50 years) were randomised to receive NOMAC/E2 (2.5 mg/1.5 mg) in a 24/4-day regimen (n = 1591) or DRSP/EE (3 mg/30 μg) in a 21/7-day regimen (n = 535) for 13 cycles. Results Estimated Pearl Indices for NOMAC/E2 and DRSP/EE were 0.38 and 0.81 in women aged ≤ 35 years and 0.31 and 0.66 for all women (18–50 years), respectively. Scheduled withdrawal bleedings were shorter and lighter among users of NOMAC/E2 and were sometimes absent altogether. Intracyclic bleeding/spotting was infrequent in both groups, and decreased over time. Type and frequency of adverse events were similar to those typically reported for COCs. Conclusions These data show that NOMAC/E2 provides high contraceptive efficacy with acceptable cycle control as well as an overall adverse event profile similar to that of DRSP/EE.

Peri-abortion contraceptive care: can we reduce the incidence of repeat abortions?

Introduction It is of great importance for repeat unwanted pregnancies to be prevented rather than aborted. We therefore sought to: determine the reasons for contraceptive failure in women seeking repeat abortions; audit the peri-abortion contraception services offered at our hospital, and make recommendations regarding peri-abortion contraception services based on the above findings. Method A self-administered questionnaire was used to determine the contraceptive practices and details of peri-abortion contraceptive counselling received by 50 women undergoing a repeat, and 83 women undergoing a first-time, abortion. Results Ninety-eight percent of women undergoing a repeat abortion reported using contraception at the time of conception, as compared to 83% of women undergoing a first-time abortion. This difference was significant (p = 0.009). Condoms were the main method used by 57% of women undergoing a repeat and 70% of women undergoing a first-time abortion. The oral contraceptive pill (OCP), including both combined oral contraceptive and progestogen-only pill, was the main method used by 37% of women undergoing a repeat and 25% undergoing a first-time abortion. Both these methods were found to be ineffective because of user-dependent failures. All women received peri-abortion contraceptive counselling, but the perceived contents varied. Follow-up contraceptive appointments were made in less than half of women. Although most women chose an optimal contraceptive method as a result of the counselling, compliance with the chosen method in women undergoing repeat abortions was poor. Conclusions Standards of audit were met with regards to receipt of contraceptive counselling and agreeing a contraceptive method before discharge. The content of this counselling needs to be improved. The ineffectiveness of the OCP and barrier methods of contraception needs to be highlighted during counselling. Adequate follow-up arrangements need to be provided to ensure compliance of the chosen method of contraception.

Oral contraceptives and venous thromboembolism consensus opinion from an international workshop held in Berlin, Germany in December 2009.

This document provides the consensus opinion from an international workshop regarding oral contraceptives and the risk of venous thromboembolism (VTE). It discusses the background and purpose of the workshop the benefits and risks of oral contraceptives describes the serious complication of VTE and assesses the VTE risks of new oral contraceptive products. It also includes information on recently published studies focused on oral contraceptives and VTE.

Fertility after discontinuation of contraception: a comprehensive review of the literature

BACKGROUND Fear of adverse effects on subsequent fertility following reversible contraceptive use is an important concern for some women. STUDY DESIGN We undertook a comprehensive and objective review of the literature for prospective studies reporting pregnancy rates in women following contraceptive cessation. One-year pregnancy rates and pregnancy outcomes are summarized. RESULTS We identified and analyzed 17 studies according to preset criteria. Typical 1-year pregnancy rates following cessation of oral contraceptives or the levonorgestrel-releasing intrauterine system (LNG-IUS) ranged between about 79% and 96% and those for copper intrauterine devices (IUDs) were almost as high, ranging between about 71% and 91%. One-year pregnancy rates following cessation of contraceptive implants were between 77% and 86%, with one study showing a rate lower than 50%. For injectable contraceptives [(a) norethisterone enanthate and (b) 5 mg estradiol cypionate and 25 mg medroxyprogesterone (Cyclofem)], only two studies were reported, with 1-year pregnancy rates following cessation of 73% and 83%, respectively. There was no evidence of increased pregnancy complications or adverse fetal outcomes following cessation of any of the reversible methods reported. CONCLUSIONS Overall, 1-year pregnancy rates following cessation of oral contraceptives, contraceptive implants and monthly injections, copper IUDs and the LNG-IUS are broadly similar to those reported following discontinuation of barrier methods or use of no contraceptive method.

The benefits and risks of using a levonorgestrel-releasing intrauterine system for contraception

The contraceptive profile of the levonorgestrel-releasing intrauterine system (LNG-IUS; Mirena®) is well established, with efficacy similar to that achieved with sterilization and rapid return to fertility after discontinuation of use. The LNG-IUS is typically associated with transient menstrual disturbance during the first few months of use, but this usually settles with continued use, with a concomitant decrease in menstrual blood loss. Overall, the safety profile of the LNG-IUS has been well established across a wide population of women, and the available data do not suggest that the LNG-IUS adversely affects bone health or increase the risk of adverse cardiovascular events or breast and uterine cancers. This article reviews the literature to provide updated information on the risks and benefits associated with the LNG-IUS, particularly focusing on its use in contraception.

A collaborative clinic between contraception and sexual health services and an adult congenital heart disease clinic

Background The success of cardiac surgery has created a new group of patients: those with ‘adult congenital heart disease’ (CHD) who may need specialist advice about contraception and pregnancy. The study objective was to investigate whether women with CHD were receiving appropriate advice on contraception. Methods The study setting comprised a combined adult CHD and contraception and sexual health clinic operating alongside each other, once a month, at Freeman Hospital, Newcastle-upon-Tyne, UK. Data were collected on 46 consecutive female patients attending the clinic between April 2002 and October 2003. Results Sixteen of the 46 (35%) women had never discussed contraception with a health professional. Nine of these women were sexually active and were using condoms. Seven of these women chose to start hormonal contraception following consultation. Ten of the 30 (33%) women who had previously discussed contraception with either their general practitioner or family planning clinic had received inappropriate advice. Of these 30 women, 24 needed contraception: 12 (50%) continued with their current method, 10 (42%) started hormonal contraception having previously used either condoms or no contraception and two (8%) changed their current hormonal method to a more effective long-term method (progestogen-only pill to progestogen implant). There had been eight unplanned pregnancies in seven patients. There was poor knowledge among the women about long-acting hormonal methods, particularly progestogen injectables and implants. Conclusions Our experience has highlighted the substandard provision of sexual health services for adults with CHD. Many of these women receive either no advice or inappropriate advice about contraception. Suitable effective reversible methods are often denied by health professionals who are concerned about the safety of hormonal contraceptives in women with ‘heart problems’. Preconception advice and birth control information should be given to all female patients with CHD, as correct information will avoid the potential risks of an unplanned pregnancy. A monthly regional combined clinic staffed by a cardiologist and family planning doctor provides the ideal opportunity for education of patients and health professionals alike. Good practice is then disseminated across specialities and into the community, encouraging multidisciplinary guidelines and pathways of referral to be developed.

Prevalence of heavy menstrual bleeding and experiences of affected women in a European patient survey

To examine the prevalence and impact of heavy menstrual bleeding (HMB) among women in Europe, and their experience of HMB assessment and management.