Norethindrone is superior to combined oral contraceptive pills in short-term delay of menses and onset of breakthrough bleeding: a randomized trial.
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ABSTRACT:
SUBMITTER: Dean J
PROVIDER: S-EPMC6537409 | biostudies-literature | 2019 May
REPOSITORIES: biostudies-literature
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Norethindrone is superior to combined oral contraceptive pills in short-term delay of menses and onset of breakthrough bleeding: a randomized trial.
Dean Joshua J Kramer Katherine J KJ Akbary Fauzia F Wade Shaunte S Hüttemann Maik M Berman Jay M JM Recanati Maurice-Andre MA
BMC women's health 20190528 1
<h4>Background</h4>To determine whether oral norethindrone acetate is superior to combined oral contraceptives (OCP) in delaying menstruation and preventing breakthrough bleeding when started late in the cycle.<h4>Methods</h4>This article comprises of a case control study followed by a pilot randomized controlled study. In the first study, four women who presented late in their cycle and desired avoiding vaginal bleeding within 10 days before a wedding were started on norethindrone 5 mg three ti ...[more]
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Project description:Importance:The Veterans Affairs (VA) health care system is the largest integrated health care system in the United States. Like most US health plans, the VA currently stipulates a 3-month maximum dispensing limit for all medications, including oral contraceptive pills (OCPs). However, 12-month OCP dispensing has been shown to improve continuation of use, decrease coverage gaps, and reduce unintended pregnancy in other practice settings. Objective:To estimate the financial and reproductive health implications for the VA of implementing a 12-month OCP dispensing option, with the goal of informing policy change. Design, Setting, and Participants:A decision model from the VA payer perspective was developed to estimate incremental costs to the health care system of allowing the option to receive a 12-month supply of OCPs up front, compared with the standard 3-month maximum, during a 1-year time horizon. A model cohort of 24?309 reproductive-aged, heterosexually active, female VA enrollees who wish to avoid pregnancy for at least 1 year was assumed. Probabilities of continuation of OCP use, coverage gaps, pregnancy, and pregnancy outcomes were drawn from published data. Costs of OCP provision and pregnancy-related care and the number of women using OCPs were drawn from VA administrative data. One-way and probabilistic sensitivity analyses were performed to assess model robustness. Main Outcomes and Measures:Incremental per-woman and total costs to the VA of allowing for 12-month dispensing of OCPs compared with standard 3-month dispensing. Results:The 12-month OCP dispensing option, modeled from the VA health system perspective using a cohort of 240 309 women, resulted in anticipated VA annual cost savings of $87.12 per woman compared with the cost of 3-month dispensing, or an estimated total savings of $2?117?800 annually. Cost savings resulted from an absolute reduction of 24 unintended pregnancies per 1000 women per year with 12-month dispensing, or 583 unintended pregnancies averted annually. Expected cost savings with 12-month dispensing were sensitive to changes in the probability of OCP coverage gaps with 3-month dispensing, the probability of pregnancy during coverage gaps, and the proportion of pregnancies paid for by the VA. When simultaneously varying all variables across plausible ranges, the 12-month strategy was cost saving in 95.4% of model iterations. Conclusions and Relevance:Adoption of a 12-month OCP dispensing option is expected to produce substantial cost savings for the VA while better supporting reproductive autonomy and reducing unintended pregnancy among women veterans.
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Project description:OBJECTIVE:To estimate whether serum etonogestrel concentrations influence bleeding patterns and related side effects in contraceptive implant users. METHODS:We conducted a prospective cross-sectional study with healthy, reproductive-aged women using etonogestrel implants for 12-36 months. Participants completed a brief questionnaire to assess their current bleeding pattern and any experience of abnormal bleeding with the implant. We then measured serum etonogestrel concentrations. We also reviewed the charts of participants to determine whether a prescription for oral contraceptive pills was ever given for treatment of implant-related bothersome bleeding. We performed multivariable logistic regression to test for associations between serum etonogestrel concentrations and both bleeding patterns and related side effects. RESULTS:We enrolled 350 women, and 59.4% reported having experienced abnormal bleeding with the contraceptive implant. Only 14.9% of participants reported amenorrhea and 37.7% reported monthly periods. Among participants with reviewable medical records (n=253), roughly 20% had received a prescription for oral contraceptive pills during implant use. Increasing serum etonogestrel concentrations were significantly associated with increasing odds of reporting abnormal bleeding (adjusted odds ratio [aOR] 1.005, P=.015) and increasing odds of having received an oral contraceptive pill prescription (aOR 1.008, P=.002). For every 100 pg/mL increase in serum etonogestrel concentration, contraceptive implant users in this study had 1.6 times the odds of reporting abnormal bleeding and 2.3 times the odds of having received a prescription as treatment for bothersome bleeding. CONCLUSION:We found both objective and subjective evidence that higher levels of progestin from the contraceptive implant were associated with bleeding side effects experienced by women in this study. Pharmacologic variation may influence the side effects women experience with a variety of hormonal contraceptive methods, in turn affecting patient satisfaction and discontinuation rates.
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