Phase 4 Study Comparison of Two Combined Oral Contraceptive Regimens and an Intravaginal Hormonal Ring Against Placebo for Management of Bleeding Problems in Women Using Implanon, the Sub-dermal Contraceptive Implant

Most Implanon users experience a reduction in the frequency and volume of menstrual bleeding, but a substantial minority experience unpredictable and frequent and/or prolonged episodes of bleeding. This is a double blind, placebo controlled, randomised study with an additional randomised non-blinded arm. Two hundred women between the ages of 18-45 years, who are Implanon users with prolonged or frequent breakthrough bleeding (WHO definition) will be recruited and randomised into 4 equal-sized treatment groups of 50 women assigned to Marvelon 7 days or 21 days, NuvaRing 21 days or placebo. Recruited subjects will maintain a daily menstrual diary chart for a minimum of 90 days prior to randomisation, and will be enrolled into the treatment phase provided that they have met one of the World Health Organization criteria for prolonged or frequent bleeding Following the initial 90 day record, eligible women will begin designated treatment on day 1 of the next episode of bleeding or spotting. Analysis of the subsequent menstrual pattern will begin from day 1 of that bleeding/spotting episode and will continue through 90 days.

开始日期2011-07-01

申办/合作机构

Family Planning NSW

[+1]

ACTRN12609000391279 / Recruiting临床4期

Comparative 12 month study of menstrually-signalled use of an ethinyl oestradiol and levonorgestrel low-dose pill and a low-dose contraceptive vaginal ring containing ethinyl oestradiol and etonogestrel to assess the number of bleeding spotting days

开始日期2009-03-07

申办/合作机构

Family Planning NSW

[+2]

100 项与 Family Planning NSW 相关的临床结果

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项与 Family Planning NSW 相关的文献（医药）

2023-08-01·Visual Communication

Practice and product: a social semiotic approach to visual communication in sexual and reproductive health promotion

作者: Zonjic, Nikolina ; van Leeuwen, Theo

This article investigates the use of visual communication in sexual and reproductive health information resources produced by an Australian Family Planning organization for different populations – people from culturally and linguistically diverse backgrounds (especially recent immigrants from Syria and Afghanistan), Aboriginal and Torres Strait Islander people, and young people from both these groups. Co-authored by a semiotician and the manager of the organization’s Health Promotion Team, it combines visual analysis of semiotic products with firsthand experience of the organization’s semiotic practices. The article shows how the same medical information leads to different health information products for different groups on the basis of ideas about what can be considered culturally acceptable to these groups. In this way, it demonstrates a social semiotic approach to the analysis of visual communication in which the findings of analysing visual products are understood in relation to the practices of their production.

2023-06-27·The Journal of Sexual Medicine

(012) Vulvovaginal Atrophy (VVA) Treatment Compliance Correlates with Improved Outcome

作者: Eden, J ; Bateson, D ; Baber, R ; Hickey, M ; Colombo, G ; Brennan, J

AbstractIntroductionTo effectively manage chronic conditions such as VVA, daily or semi-daily patient compliance to a treatment regimen is essential. Despite the fact that risk of cancer or cancer recurrence prevents many women from treating their VVA with hormone therapy, patient compliance to over-the-counter moisturizers and lubricants is relatively low: 40% of women find them completely unsatisfactory due to difficulty of use and lack of desired treatment outcome. As an alternative to current therapies, an at-home, easy-use therapeutic ultrasound device was developed with the potential to increase treatment compliance and help women successfully manage their VVA. This study aimed to optimize patient compliance by increasing ease of device use, minimizing therapy side effects, and tracking self-reported patient data electronically.ObjectivesTo assess the correlation between patient-reported and objectively tracked actual compliance to therapy, as well as the association between treatment compliance and improvement in patient condition.MethodsThis randomized (1:1), double-blind, sham-controlled trial assessed the effectiveness of a daily, at-home ultrasound therapy, applied to the vaginal introitus for 8 min/day over the course of 12 weeks, on menopausal vaginal dryness in an ambulatory setting (Clinicaltrials.gov NCT00583-1). In 30 post- menopausal women (ages 48-70), device use compliance was collected via a self-reported electronic diary completed daily on a mobile phone. Objective compliance data were obtained from a logger installed in all devices, which recorded the duration and time the device was used every day. Participants self- assessed change (from baseline to 12 weeks) in VVA symptoms (vaginal dryness, soreness, irritation, dyspareunia) measured by the Vaginal Assessment Scale (VAS) with a 4-level response score ranging from none, mild, moderate, to severe. Healthcare providers evaluated change in vaginal tissue response (tissue elasticity, vaginal fluid, pH, mucosa, and vaginal moisture) assessed by the Vaginal Health Index (VHI) giving a numerical score (1-5) for each of the 5 parameters.ResultsAfter week-12 follow-up, participants in the operating group self-reported compliance (mean ± SE%) of 85.4 ± 5.4% and the device log objectively tracked compliance of 80.7 ± 7.2% (paired t-test, P=0.17). The sham group had self-reported compliance of 89.5 ± 2.1% and the device log compliance of 82.5 ± 5.2% (P=0.14). There was no significant difference (ANOVA) between operating and sham groups compliance for self-reported (P =0.46) or objective log data (P =0.83). With both operating and sham groups combined, there was a significant strong correlation (r=0.76, P<0.0001) between self-reported and device log compliance. Linear regression showed a significant positive dose-response between treatment and change in VHI score from baseline to week 12 (r=0.51, P=0.04). A smaller positive correlation was observed between treatment compliance and participants’ self-assessed change in VAS score (r=0.40, P=0.28).ConclusionsObjective device use compliance was high (80.7-82.5%) across both groups assessed, indicating general participant desire to receive the therapy. In addition, participants with higher treatment rates had better scores in VHI, which indicated decreased VVA severity. For post-menopausal women, high adherence to the daily at-home ultrasound therapy proved efficacious in improving their condition of VVA and could offer a new therapeutic option.DisclosureYes - Madorra.Industry funding only - investigator initiated and executed study – Yes.

2020-01-01·Australian Health Review4区 · 医学

Corrigendum to: Cost–benefit analysis of enhancing the uptake of long-acting reversible contraception in Australia

4区 · 医学

Article

作者: Kristine Concepcion ; Jane Estoesta ; Deborah Bateson ; Jessica Botfield ; Sarina Lacey ; Kevin McGeechan

ObjectiveLong-acting reversible contraception (LARC) is the most effective form of reversible contraception, but its use in Australia is low compared with other countries. The aim of this study was to evaluate the economic effect of an increase in LARC uptake to international rates.MethodsAn economic model was designed to assess two scenarios, namely increasing the current rate of LARC uptake of 12.5% to the international benchmark of 14.8% among: (1) women currently using the oral contraceptive pill (OCP); and (2) women at risk of pregnancy and not using contraception. Model inputs included cost of contraceptive methods, discontinuation rates and abortion and miscarriage costs associated with unintended pregnancies.ResultsWomen who switch from an OCP to LARC would save A$114–157 per year. Those not currently using any contraception who adopt LARC would incur costs of A$36–194 per year, but would reap savings from the reduction in unintended pregnancies. Over 5 years there would be a net saving of A$74.4 million for Scenario 1 and A$2.4 million for Scenario 2.ConclusionGreater use of LARC would result in a net gain in economic benefits to Australia. These benefits are largely driven by women switching from an OCP to LARC who have reduced costs, as well as women wishing to avoid pregnancy who choose to use LARC rather than no method. This evidence will support women making an informed contraceptive choice and policy makers in increasing the accessibility of LARC.What is known about the topic?LARC is the most effective form of reversible contraception, but uptake in Australia is relatively low.What does this paper add?There are economic benefits to society for women who switch from an OCP to LARC, as well as for women who switch from no contraception to LARC.What are the implications for practitioners?The findings of this study will support women in making an informed contraceptive choice and policy makers in increasing the accessibility of LARC.

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