Continuous Norethisterone Acetate versus Cyclical Drospirenone 3 mg/Ethinyl Estradiol 20 µg for the Management of Primary Dysmenorrhea in Young Adult Women.

STUDY OBJECTIVE: To evaluate the efficacy of continuous norethisterone acetate (NET-A), 5 mg (group N) vs cyclical combined oral contraceptive pill (COC) consisting of drospirenone 3 mg/ethinyl estradiol 20 µg pills (group P) in treating dysmenorrhea in young adult women. DESIGN, SETTING, AND PARTICIPANTS: This prospective, open-label, nonrandomized study included 38 Jordanian patients: 20 patients in group N and 18 patients in group P. INTERVENTIONS: Continuous NET-A 5 mg daily or cyclical COC. MAIN OUTCOME MEASURES: Pain scores, adverse effects, analgesic use, school absence, and cost. RESULTS: Thirty-eight patients used NET-A or COC for 6 months. All participants had almost the same starting levels of visual analogue scale (VAS) scores. Both drugs were similar in suppressing dysmenorrhea at the 3-month follow-up visit; VAS score mean (±SD) in group N and P were 1.30 ± 1.22 and 1.28 ± 0.83 (P = .22), respectively, and after 6 months, with mean VAS scores (±SD) of 1.30 ± 1.22 and 1.28 ± 0.83, respectively (P = .95). The cost of the treatment in the N group was much less than in the P group. Participants in the N group were less likely to use pain killers: 20% and 44% in the N and P groups, respectively (P = .006) in the first month and only 5% and 17% (P = .019) in the N and P groups, respectively, at the 3-month follow-up, and none of them used any analgesics at the 6-month follow-up. CONCLUSION: A continuous NET-A regimen is a well tolerated, effective, and inexpensive option for dysmenorrhea treatment and was as good as COC.

Ovulation inhibition doses of progestins: a systematic review of the available literature and of marketed preparations worldwide.

BACKGROUND: The objective of this analysis was to provide a comprehensive review of ovulation inhibition data of progestins currently available worldwide. This analysis may serve as a reference tool for research on new progestin molecules. STUDY DESIGN: We used literature search engines to detect data of progestin monotherapies on ovulation inhibition in humans. Only treatments with stable dosing during a cycle were accepted. In a second step, we tried to estimate the 99% ovulation inhibiting doses and their fiducial confidence limits using the probit dose-response model. Finally, we analyzed the progestin doses of combined oral contraceptives currently on the market. RESULTS: We found original data on 29 marketed and nonmarketed progestins in a total of 60 publications, published between 1956 and May 2010. Details on methods used for determining ovulation, number of doses and daily dose of each tested progestin, number of subjects, cycles and ovulations are summarized in a table. We designed one example of a dose-response curve using the statistical model. For most progestins, literature data were insufficient for this purpose. A total of 13 progestins are components of oral contraceptives currently on the market worldwide, five of them in combination with 20 mcg ethinyl estradiol (EE). CONCLUSION: This review provides a comprehensive overview of all progestins ever tested for their ovulation inhibition potency and a summary of all preparations currently on the world market, including their regimens and their combinations with EE.

Behind-the-counter status and availability of emergency contraception.

OBJECTIVE: The objective of the study was to determine whether the 2006 Food and Drug Administration approval of Plan B for behind-the-counter status increased availability. STUDY DESIGN: We conducted a survey in 2005 and 2007 of pharmacies listed in Atlanta, GA, Boston, MA, and Philadelphia, PA. We measured ability to dispense Plan B within 24 hours. Also measured were reasons for lack of availability and cost of Plan B. RESULTS: Pharmacists were interviewed at 1087 pharmacies (75% response rate) in 2005 and 795 pharmacies (82% response rate) in 2007. In 2007, 8% of pharmacies were unable to provide Plan B within 24 hours, compared with 23% of pharmacies in 2005 (P < .001). The total refusal rate in 2007 was half the rate of 2005 (2% vs 4%, P = .004). The average cost of Plan B was $43. CONCLUSION: Availability of Plan B in Atlanta and Philadelphia increased after it was awarded behind-the-counter status.

Cost-effectiveness analysis of levonorgestrel intrauterine system and thermal balloon ablation for heavy menstrual bleeding.

OBJECTIVE: To compare the cost-effectiveness of levonorgestrel intrauterine system (LNG-IUS) (Mirena; Schering Co., Turku, Finland) and thermal balloon ablation (Thermachoicetrade mark; Gynecare Inc., Menlo Park, CA, USA) for the treatment of heavy menstrual bleeding. DESIGN: An open, pragmatic, prospective randomised trial. SETTING: A menstrual disorders clinic at National Women's Hospital, Auckland, New Zealand. POPULATION: Seventy-nine women with self-defined heavy menstrual bleeding randomised to the LNG-IUS (40 women) or the thermal balloon ablation (39 women). METHODS: Decision tree modelling using primary source data was used to identify the incremental cost-effectiveness of the two treatments. MAIN OUTCOME MEASURES: Direct and indirect costs of medical treatment, including treatment costs, subsequent medical procedures, lost income and medical treatment for failed procedures. The change in quality of life as assessed by the Short Form-36 (SF-36) measured between time of treatment and 24 months was the primary outcome measure. Economic modelling examined the expected cost and outcome for a woman entering each treatment. Sensitivity analysis explored the robustness of the results. RESULTS: The expected cost of treatment was $NZ1241 ($US869) for the LNG-IUS and $NZ2418 ($US1693) for the thermal balloon ablation. The LNG-IUS was associated with an increase of 15 points on the SF-36 scale, compared with 12 points for the thermal balloon ablation. Sensitivity analysis indicates that the results are robust to a 25% decrease in the price of the primary cost drivers and to variations in the rates of failed treatment between the conditions. CONCLUSION: The LNG-IUS would appear to be cost-effective when compared with the thermal balloon ablation for treatment of heavy menstrual bleeding.

Cost savings from use of emergency contraceptive pills in Australia.

BACKGROUND: Emergency contraception, which prevents pregnancy after unprotected sexual intercourse, has the potential to reduce significantly the incidence of unintended pregnancy and the consequent need for abortion and to reduce medical care costs. AIM: To determine the savings generated by use of Postinor-2, the levonorgestrel regimen of emergency hormonal contraception, in Australia. METHODS: We modelled the cost savings when women obtain Postinor-2 directly from a pharmacist where cost savings are measured as the cost of pregnancies averted by use of Postinor-2 per dollar spent on Postinor-2. RESULTS: Each dollar spent on a single treatment with Postinor-2 saves A$2.27-A$3.81 in direct medical care expenditures on unintended pregnancy depending on assumptions about savings from costs avoided by preventing mistimed births. Postinor-2 is cost-saving even under the least favourable assumption that mistimed births when prevented today occur 2 years later. Results are robust even to large changes in model input parameters. CONCLUSION: Emergency contraception is cost saving. More extensive use of emergency contraception could save considerable medical and social costs by reducing unintended pregnancies, which are expensive.

Is Cerazette the minipill of choice?

Around 5% of women aged 16-49 years in Great Britain use a progestogen-only pill (POP; 'minipill') as contraception. These pills are used as alternatives to combined oral contraceptives (COCs), compared to which they are less reliable at preventing pregnancy: the estimated contraceptive failure rate of POPs is 0.5 pregnancies per 100 woman-years when used consistently and correctly, compared with 0.1 per 100 woman-years for COCs. Cerazette (Organon), a new POP, is being promoted by the company as "the first oestrogen free pill to consistently inhibit ovulation", as having "the efficacy of a combined pill, with the reassurance of an oestrogen free pill" and offering "reliable contraception for women of any reproductive age". Here, we consider whether Cerazette offers advantages over established POPs.

Acceptability of Norplant at a well-woman clinic in Turkey.

OBJECTIVE: To make an assessment of the acceptability and cost of subdermal implants, a new method in Turkey, in a free-choice environment. METHODS: The records of women attending a university well-woman clinic in Istanbul, Turkey, were analyzed retrospectively. Among other contraceptives registered in the country, the women were offered subdermal contraceptive implants (Norplant) during counselling sessions. The women who chose implants were invited to attend for follow-up three times during the first 12 months and were advised to return annually thereafter. An estimation of cost was performed for Norplant, using the government price of the implant and the wage rates of public-sector staff. An estimation of cost was also performed for oral contraceptives. RESULTS: Among the 5650 women who applied to the Clinic for contraception between 1 January 1995 and 31 December 1998, 274 women decided to use implants, giving an initial acceptance rate of 5.1%. Continuation rates were 91.8%, 71.6% and 42.5% at 12 months, 24 months and 36 months, respectively. There were no pregnancies within the study period. The only demographic characteristic that was positively related to the acceptability of Norplant was younger age. The cost of contraception with Norplant was found to be lower than that for oral contraceptives. CONCLUSION: The high initial acceptance and continuation rates, combined with its high efficacy, make Norplant a valuable tool for Turkey's National Family Planning Program. Contraception with Norplant is also a cost-effective method, at least for the public sector.

Increased number of induced abortions in Norway after media coverage of adverse vascular events from the use of third-generation oral contraceptives.

After the press release in Lancet (October 18, 1995) of increased risks for adverse vascular events in users of pills containing desogestrel and gestodene the total sales of oral contraceptives dropped over a two-month period by 17%, while sales of the only desogestrel brand available (Marvelon) dropped by over 70% in Norway. From sales, we can estimate that more than 45,000 women either changed from Marvelon to a second or first-generation brand or stopped using OCs. In total, more than 25,000 women discontinued OC use in Norway during November and December of 1995. Abortion data from one Norwegian county, representing 6-7% of the Norwegian population, show no statistically significant changes in the total number of induced abortions from the first quarter of 1996 as compared with that of the first quarter in preceding years. However, abortion rates that had been steadily decreasing from 1992 through 1995 in women 24 years old or younger, were promptly interrupted by a significant 36% increase during the first quarter of 1996. Most of the additional cases were found among single, childless students. The observed increased abortion rate among younger women is most probably linked to changes in contraceptive use during the pill scare of the late October through December of 1995, during which time these women conceived.

PIP: Reports appearing in the mass media in October 1995 citing a two-fold increase in the risk of venous thromboembolism in users of third-generation compared to second-generation oral contraceptives (OCs) were followed, in Norway, by a 17% drop in total OC sales and a 70% drop in sales of the only third-generation OC (Marvelon) on the market. More than 25,000 Norwegian women discontinued OC use in November-December 1995. Abortion data from one Norwegian county, representing 6-7% of the country's population, showed no significant changes in the total number of induced abortions in the first quarter of 1996 compared to the first quarter of preceding years. However, the steady decrease in the abortion rate for women 24 years of age or younger recorded in 1992-95 was interrupted by a 36% increase during the first quarter of 1996 (5.7/1000, compared with 4.2/1000 in the first quarter of 1995). Most of the growth in abortion cases occurred among single, childless students--a subgroup in which OC use tends to be high. Although this finding suggests that the mass media's "pill scare" may have led many young women to discontinue OC use or switch to less effective formulations, evaluation of the full effect of this event cannot be completed without national data on induced abortion and the completion of birth registration.

A cost-benefit analysis of four hormonal contraceptive methods.

This paper presents the results of a cost-benefit analysis conducted for pregnancy prevention treatment with four hormonal methods of contraception using a managed-care viewpoint. The therapies analyzed are medroxy-progesterone acetate injection (Depo-Provera), levonorgestrel subdermal implants (Norplant), progestogenonly oral tablets (Nor-QD), and combination progestogen/estrogen oral tablets (Ortho-Novum 7/7/7). Cost and benefits associated with the use of therapies are identified and analyzed based on the cost per patient-day of effective pregnancy prevention. The analysis demonstrates that all four methods have a positive net benefit, with Depo-Provera having the highest net benefit. This information can provide decision makers within a pharmacy and therapeutics committee of a managed-care organization the framework on which to base formulary decisions.