Can a Three Months Treatment With Oral Desogestrel Prior to Insertion of the Etonogestrel Subdermal Implant Improve Continuation Rate at One Year?
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 67
- 主要终点
- Tolerance of Implanon
研究概览
简要总结
Objective: The etonogestrel subdermal implant (ESI) is an effective and safe method of contraception. Although highly efficient, ESI produces often side effects that reduce its tolerance and acceptance. Daily oral desogestrel (DSG) prior to the insertion of ESI might help reduce its premature discontinuation. Our aim was to evaluate if this pre-treatment increases ESI's tolerance.
Methods: Between 15.08.2016 and 30.09.2019, the investigators conducted a randomized prospective study of women aged 18 to 42 years who were interested to use Implanon and were willing to have 90 days of pre-treatment with DSG, in the family planning clinic of the Geneva University Hospitals and the Hospital of Basel. Women were randomized into either the study ESI only group or to the DSG + ESI group. In the DSG + ESI group, patients were given a 3 months' supply of 75µg of DSG before the insertion of the ESI.
A 3 months visit was pre-programmed for all participants where the bleeding calendar and the questionnaires were collected. All patients were called over the phone after 12 months post ESI insertion in both groups.
详细描述
Study and treatment periods
1 year of patient recruitment 15 months of follow up (90 days OD plus 1 year Implant or 1 year Implant)
Measurements and Procedures:
Assessment of premature ablation (PA) in months 3-12 (ESI only) or 3-15 (OD+ESI). This will require a contact with all patients at 12/15 months to verify if implant is still in place, and if it was removed, why (and possibly to also reassess symptoms).
Women with known PA can be exempted from this follow-up. In case of PA, reasons will be explored and questioned.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 42 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
ESI (Implanon NXT® subdermal implant)
In this group, the implant was inserted immediately after thorough explanations of the potential side effects and possible adverse events
干预措施: Implanon NXT® subdermal implant (Drug)
DSG + ESI(Desogestrel +Implanon NXT® subdermal implant)
In this group, patients were given a 3 months' supply of 75µg of DSG to be started immediately after which insertion of an ESI was proposed. Similarly, explanations of the potential side effects and possible adverse events were presented to the patient before treatment initiation.
干预措施: Desogestrel 0.075 milligram (Drug)
DSG + ESI(Desogestrel +Implanon NXT® subdermal implant)
In this group, patients were given a 3 months' supply of 75µg of DSG to be started immediately after which insertion of an ESI was proposed. Similarly, explanations of the potential side effects and possible adverse events were presented to the patient before treatment initiation.
干预措施: Implanon NXT® subdermal implant (Drug)
结局指标
主要结局
Tolerance of Implanon
时间窗: at 1 year after implant insertion (or at ablation)
self-reported
次要结局
- specific symptoms(at 1 year after implant insertion)
- Discontinuation of implant,(at any time after insertion through study completion, an average of 1 year)
研究者
Michal Yaron
Head of Unit Ambulatory Gynecology
University Hospital, Geneva
