Can initial vaginal bleeding patterns in etonogestrel implant users predict subsequent bleeding in the first 2 years of use?

ObjectivesTo evaluate if a simple method for characterizing vaginal bleeding patterns in etonogestrel contraceptive implant users can predict subsequent patterns and bleeding-related discontinuation over the first 2 years of use.Study designWe reanalyzed phase 3 study bleeding data for non-breastfeeding participants from the United States, Europe, Russia and Chile during the first 2 years of implant use to characterize and correlate bleeding patterns. We used 90-day reference periods with period 1.1 starting at Day 29 and ending at Day 118. We dichotomized bleeding patterns as "favorable" (amenorrhea, infrequent bleeding and normal frequency bleeding without prolonged bleeding) or "unfavorable' (prolonged and/or frequent bleeding) and tracked user groups based on these bleeding patterns in reference period 1.1 through Year 1 and from Year 1 through Year 2, respectively.ResultsWe evaluated data from 537 and 428 women with up to 1 and 2 years use, respectively. Of the 325 (60.5%) women with favorable bleeding in reference period 1.1, 275 (84.6%) reported favorable bleeding also in reference period 2, 197 (60.6%) reported favorable bleeding throughout Year 1, and favorable bleeding in 75-85% of reference periods in Year 2. Among 212 (39.5%) women with unfavorable bleeding in reference period 1.1, 118 (55.7%) continued with unfavorable bleeding in reference period 2, while about 40%-50% reported favorable patterns in RP 2, 3 and/or 4. Initial favorable bleeding resulted in lower discontinuation rates than initial unfavorable bleeding in years 1 (3.7% vs 12.7%, p≪.0001) and 2 (2.5% vs 16.5%, p≪.0001).ConclusionImplant users with favorable bleeding in the first reference period are likely to continue with favorable bleeding over the next 2 years. Initial bleeding patterns predict overall continuation rates in years 1 and 2. Implications Statement When evaluating vaginal bleeding in any 90-day reference period over 2 years of etonogestrel implant use, approximately 80% of women with favorable and 40% with unfavorable bleeding patterns will have favorable bleeding in the next reference periods. These findings can facilitate counseling regarding bleeding for women using the etonogestrel implant

Global Consensus Position Statement on the Use of Testosterone Therapy for Women

The only evidence-based indication for testosterone for women is for HSDD. There are insufficient data for using testosterone for any other symptom/condition or for disease prevention

Global fee prohibits postpartum provision of the most effective reversible contraceptives

Early postpartum access to highly effective reversible contraceptives (intrauterine contraceptives (IUCs) and the implant) and sterilization is key to helping women prevent unintended pregnancy.[1] Yet most current hospital reimbursement policies deny postpartum women access to IUCs and implants prior to hospital discharge. For women whose deliveries are covered by private insurance or Medicaid, hospitals receive a global fee based on the diagnosis-related group (DRG) for all delivery-related care. Postpartum sterilization is carved out by insurance companies and Medicaid as a procedure that may be billed separately from the global fee, which in turn means that hospitals are not financially driven to deny such procedures. In contrast, in most states, postpartum IUCs and implants are not carved out for separate reimbursement and the costs of the devices must be deducted from the DRG payment. Since the wholesale acquisition costs for IUCs and implants range from $600 to$775, covering those costs would be fiscally rash. Consequently, most hospitals do not permit postpartum placement of the most effective reversible methods, a policy that not only hinders women’s ability to space their pregnancies but also prohibits an important option for those who have completed childbearing but do not wish to be sterilized. Equally, for women who are covered by Medicaid and desire postpartum sterilization, the twin requirements of a minimum 30-day waiting period after signing the consent form and having that form present in the delivery room still inhibit access.[2] For these women, postpartum placement of IUCs and implants would be a valuable alternative. Although the Affordable Care Act (ACA) may go a long way towards expanding outpatient access to the most effective methods of contraception, it does not specifically facilitate inpatient access to IUC or the implant for new mothers prior to hospital discharge

The US etonogestrel implant mandatory clinical training and active monitoring programs: 6-year experience

ObjectiveThe objective was to monitor the effectiveness of the etonogestrel implant clinical training program through a voluntary active monitoring program (AMP).Study designUS health care providers underwent mandatory training by the manufacturer on etonogestrel implant insertion, localization and removal. After training, health care providers could enroll in a voluntary AMP to provide outcome data to meet a postmarketing commitment of the manufacturer with the US Food and Drug Administration (FDA). Those who volunteered completed and faxed forms to the manufacturer after implant insertion and removal detailing the procedure and device-related outcomes, including insertion-, localization- or removal-associated events. Experts reviewed outcome data quarterly, which the Sponsor then reported to the FDA.ResultsAmong 42,337 health care providers completing the training program, 4294 (10.1%) volunteered to participate in the AMP. The 26,198 forms submitted over 6.4 years included more insertion (n=20,497) forms than removal forms (n=5701). The volunteers reported 646 events on 566 (2.2%) forms related to insertion (n=197), localization (n=34), removal (n=357) and "other" (n=58). Clinically important events included noninsertion (n=4), serum etonogestrel positive but implant not found (n=1), and possible nerve (n=66) or vascular (n=5) injury. The reports did not include any insertion-, localization- or removal-associated hospitalizations. Eight (0.14%) removal reports described referral for surgical implant removal.ConclusionEvents related to insertion, localization or removal of the etonogestrel implant are uncommon among US providers who received mandatory training in the use of the implant.ImplicationsThis report presents results from the first mandatory US contraceptive training program. Health care providers volunteered to report information about etonogestrel implant insertion, localization and removal. Although the data do not demonstrate whether a mandatory program improves outcomes, they elucidate the utility and real-life experience that clinical training programs can provide

Extended regimen combined oral contraception: A review of evolving concepts and acceptance by women and clinicians

The clinical utility of extended regimen combined oral contraceptives (COCs) is increasingly being recognised. Our objective was to understand the attitudes of women and clinicians about the use of these regimens. We present the rationale for extended regimen COCs from a historical perspective, and trace their evolution and growing popularity in light of their clinical benefits. We conclude by offering potential strategies for counselling women about extended regimen COC options

Practical advice for avoidance of pain associated with insertion of intrauterine contraceptives

Few studies in the scientific literature provide clear direction on the prevention or management of pain associated with intrauterine contraceptive (IUC) placement. Those that have been published have studied small numbers of women and fail to provide definitive conclusions. There are also no guidelines available detailing recognised standard approaches to this problem. The consensus recommendations in this review focus primarily on non-pharmacological and often non-evidence-based interventions. This review includes general considerations, practical recommendations for both routine and more difficult cases and guidance on the optimal choice of instruments. General considerations, including pre-insertion counselling, the setting for the procedure, the confidence and technique of the provider and the interplay between the provider and assistant, can influence women's level of anxiety and, in turn, influence their perception of pain and their overall experience. Further studies are required to refine the optimal strategy for managing pain associated with IUC insertion4015460sem informaçã

Practical Advice For Avoidance Of Pain Associated With Insertion Of Intrauterine Contraceptives.

Few studies in the scientific literature provide clear direction on the prevention or management of pain associated with intrauterine contraceptive (IUC) placement. Those that have been published have studied small numbers of women and fail to provide definitive conclusions. There are also no guidelines available detailing recognised standard approaches to this problem. The consensus recommendations in this review focus primarily on non-pharmacological and often non-evidence-based interventions. This review includes general considerations, practical recommendations for both routine and more difficult cases and guidance on the optimal choice of instruments. General considerations, including pre-insertion counselling, the setting for the procedure, the confidence and technique of the provider and the interplay between the provider and assistant, can influence women's level of anxiety and, in turn, influence their perception of pain and their overall experience. Further studies are required to refine the optimal strategy for managing pain associated with IUC insertion.4054-6

Comment On 'practical Advice For Avoidance Of Pain Associated With Insertion Of Intrauterine Contraceptives': Authors' Response.

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