跳至主要内容
临床试验/DRKS00034125
DRKS00034125已完成不适用

Inne MINILAB Effectiveness Study for Contraceptive Use

Feral GmbH0 个研究点目标入组 300 人开始时间: 2024年5月6日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
300

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

年龄范围
18 Years 至 one(—)
性别
Female

入选标准

  • I1) Healthy menstruating women, with previous average menstrual cycle lengths of 22 to 35 days inclusive during the past three cycles,
  • I2) Living in Germany
  • I3) Over 18 years old
  • I4) Women using an iPhone 5S or newer, with a Wireless Fidelity (Wi-Fi) connection of at least 2.4 GhZ.
  • I5) Women agreeing to have regular heterosexual intercourse during the duration of the study (at least once per cycle).
  • I6) Women agree to not use any form of contraception during their infertile days, and must use one of the following contraceptive methods during their fertile window: abstinence, condom, or diaphragm.
  • I7) Women accept that there is a risk of unintended pregnancy associated with this study and are in this case intending to carry the pregnancy to term.

排除标准

  • E1) Women currently undergoing or having recently undergone hormonal treatment such as hormonal contraception (including oral, progesterone-only and combined hormonal methods, or any other hormonal contraceptive program), fertility treatments, or hormone replacement therapy. Since stopping the treatment, the subject has not yet had 3 regular menstrual cycles. An exception to this is hormonal emergency contraception (morning after-pill).
  • E2) Women currently using intrauterine copper devices. Since stopping the treatment, the subject has not yet had 1 regular menstrual cycle.
  • E3) Women currently undergoing or having recently undergone a treatment which may affect her menstrual cycle (this would be mentioned in the patient information leaflet of the treatment, e.g. certain antipsychotics like risperidone, or chemotherapeutic drugs like methotrexate).
  • E4) Women currently pregnant or who have recently been pregnant (until after the third consecutive period, even if the pregnancy was not carried to term).
  • E5) Women with known polycystic ovary syndrome or known endometriosis.
  • E6) Women currently breastfeeding. Women who stopped breastfeeding but did not yet have 3 regular menstrual cycles.
  • E7) This study is testing the inne MINILAB as a form of contraception. Like all contraception, there is a risk of pregnancy. Women who are not OK with any risk of pregnancy.
  • E8) Women who have had or have menopausal symptoms such as hot flashes or night sweats.
  • E9) Women with diagnosed infertility or with an infertile partner, including history of surgical sterilization.
  • E10) Participation in another clinical trial.
  • E11) Subject in custody by order of an authority or a court of law.
  • E12) Subject is a dependent person, e.g. a relative, family member, or member of the Investigator’s or Sponsor’s staff.
  • E13) Women with current wishes for pregnancy.

研究者

发起方
Feral GmbH

相似试验