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临床试验/NCT01299116
NCT01299116已完成4 期

Long-Acting Reversible Contraception: New Research to Reduce Unintended Pregnancy

FHI 3601 个研究点 分布在 1 个国家目标入组 916 人开始时间: 2011年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
FHI 360
入组人数
916
试验地点
1
主要终点
Contraceptive Method Discontinuation

研究概览

简要总结

In the proposed study, women aged 18-29 seeking oral or injectable contraception will be offered an opportunity to try LARC instead; the FDA-approved options include two types of intrauterine products and one type of subdermal contraceptive implant. Over a 24 month period, the experiences of LARC users will be compared to the experiences of those opting for their initial short-acting method.

详细描述

In this partially randomized patient preference study, women aged 18-29 seeking oral or injectable contraception will be offered an opportunity to try LARC instead; the FDA-approved options include two types of intrauterine products and one type of subdermal contraceptive implant. Over a 24-month period, the experiences of LARC users will be compared to the experiences of those opting for their initial short-acting method. It is expected that 38% of the participants using short-acting methods will stop using them during the first year and be at risk of unintended pregnancy. In contrast, less than 20% of LARC users will want to have their contraceptive removed. Continuation rates will be measured and pregnancies will be tallied in the two groups to document any differences that emerge.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 29 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 18 to 29 years of age;
  • sexually active;
  • seeking oral or injectable contraception;
  • working cell phone;
  • working email account;
  • willingness to be contacted by the clinic staff or study coordinators; and,
  • willingness to complete questionnaires.

排除标准

  • currently pregnant;
  • previous use of a long-acting reversible contraceptive (LARC) method; and,
  • medical contraindications for oral contraceptives and injectables.

研究组 & 干预措施

Preference SARC

Other

Participants received one of a variety of oral contraceptives or DMPA

干预措施: DMPA (Drug)

Preference SARC

Other

Participants received one of a variety of oral contraceptives or DMPA

干预措施: oral contraceptives (Drug)

Randomized LARC

Experimental

Participants receive one of the following interventions:

Implanon® or Nexplanon®; ParaGard®; Mirena®

干预措施: Implanon® (Drug)

Randomized LARC

Experimental

Participants receive one of the following interventions:

Implanon® or Nexplanon®; ParaGard®; Mirena®

干预措施: ParaGard® (Drug)

Randomized LARC

Experimental

Participants receive one of the following interventions:

Implanon® or Nexplanon®; ParaGard®; Mirena®

干预措施: Mirena® (Drug)

Randomized SARC

Active Comparator

Participants received one of a variety of oral contraceptives or DMPA

干预措施: DMPA (Drug)

Randomized SARC

Active Comparator

Participants received one of a variety of oral contraceptives or DMPA

干预措施: oral contraceptives (Drug)

结局指标

主要结局

Contraceptive Method Discontinuation

时间窗: 24 months

次要结局

  • Participant Attitudes to LARC vs SARC(24 months)
  • Unintended Pregnancy(24 months)

研究者

发起方
FHI 360
申办方类型
Other
责任方
Sponsor

研究点 (1)

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