EUCTR2019-001876-12-DE进行中（未招募）1 期
A multicentre, uncontrolled trial on the contraceptive efficacy, safety, tolerability and pharmacokinetics of LPRI-424 (dienogest 2 mg / ethinyl estradiol 0.02 mg) during 13 cycles
Chemo Research S.L.0 个研究点目标入组 850 人开始时间: 2019年10月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 850
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1.Sexually active, postmenarcheal and premenopausal female subjects, at risk of pregnancy, aged between 18 and 45 years (inclusive).
- •2.Women who
- •a.have never used hormonal contraceptives before consent (naïve users),
- •b.have used hormonal contraceptives in the past, but have had a hormonal contraceptive-free period before consent and a full menstrual cycle (see Section 4.2) during the drug-free period (previous users)
- •c.directly switch from another hormonal contraceptive (switchers).
- •3.Only for subjects who were not pregnant and did not use hormonal contraception during the last six months before consent: Regular cycles (i.e. cycle length between 24 and 35 days) during the last six months.
- •4.Only for women who were pregnant within the last six months before consent: At least three complete menstrual cycles after pregnancy.
- •5.At screening, systolic blood pressure = 140 mm Hg and diastolic blood pressure = 90 mm Hg.
- •6.Be able and willing to provide written informed consent, prior to undergoing any trial-related procedure.
- •7.Willing to use trial contraception for thirteen 28-day cycles.
- •8.Be willing to have intercourse in each cycle of the trial without the need to use back-up contraceptive.
- •9.Be willing to state that, to her best knowledge, her male sexual partner/partners has/have not had a vasectomy or been previously diagnosed as infertile.
- •10.Agree not to participate in any other clinical trials during the course of this trial (participation in a non-interventional study is allowed).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 140
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Pregnancy.
- •2.Wish for pregnancy.
- •3.Breastfeeding.
- •4.Subject is known to or suspected of not being able to comply with the trial protocol, the use of the trial medication or the use of the trial diary.
- •5.History of infertility.
- •6.BMI > 35 kg/m2
- •7.Current smoker with age > 35 years and/or with BMI > 30 kg/m² (at the time of trial enrolment).
- •8.Abnormal finding on pelvic, breast or ultrasound examination that in the investigator’s opinion contraindicates participation in the trial.
- •9.Women =21 years of age with a Papanicolaou (Pap) smear reading low-grade squamous intraepithelial lesion (LGSIL) or higher at screening (or 6 months prior to screening date). Subjects with atypical squamous cells of undetermined significance (ASC-US) can be included if they are negative for high-risk human papilloma virus (HPV) strains. Subjects < 21 years of age do not require a Pap smear.
- •10.Known contraindication or hypersensitivity to ingredients or excipients of the IMP, including:
- •a.Presence or risk of a venous thromboembolism (VTE)
- •b.Presence or risk of an arterial thromboembolism (ATE)
- •c.Presence or history of pancreatitis, if it is associated with severe hypertriglyceridemia
- •d.Presence or history of liver diseases in which liver function has not returned to normal (also Dubin-Johnson and Rotor syndrome)
- •e.Current or previous liver tumours
- •f.Known or suspected sex hormone-dependent malignant tumours (e.g., breast or endometrium)
- •g.Undiagnosed vaginal bleeding
- •h.Unexplained amenorrhea
- •i.Concomitant use of medicinal products containing ombitasvir/paritaprevir/ritonavir or dasabuvir
- •11.Uncontrolled thyroid disorder (i.e., not on stable dose of thyroid replacement for at least two months at the time of consent).
- •12.Uncontrolled concomitant diseases (i.e., not on a stable treatment dose for at least two months at the time of consent).
- •13.Evidence or history of alcohol, medication or drug abuse (within the last 12 months prior to consent).
- •14.Known HIV infection.
- •15.Known current or chronic hepatitis B or C.
- •16.Known HPV infection with strains 16, 18 or other high-risk strains as per screening examination.
- •17.Less than 3 menses after discontinuing dosing of depot medroxyprogesterone acetate (DMPA or Depo-Provera®) or any combined injectable contraceptive (e.g., Cyclofem®) prior to consent.
- •18.Long-term treatment (longer than seven consecutive days within a month prior to V1b) of any medication that might interfere with the efficacy of hormonal contraceptives, e.g.:
- •a.Anticonvulsants (e.g. phenytoin, carbamazepine, oxcarbazepine, topiramate, felbamate)
- •b.Barbiturates (e.g. primidone)
- •c.Specific antibiotics (such as rifampin or rifampicin [tuberculosis infection] and griseofulvin [fungal infections])
- •d.HIV medication (such as ritonavir, neviparine and efavirenz)
- •f.Griseofulvin
- •g.St. John’s wort (hypericum perforatum)
- •h.Metoclopramide
- •19.Prohibited medication including the use of estrogens, progestogens, strong microsomal enzyme-inducing drugs (intensive and moderate frequency).
- •20.Administration of medication containing human chorionic gonadotropin (hCG) within a month prior to V1b.
- •21.Progestin-releasing intra-uterine device (IUD) or contraceptive implant received or in place within the last two months prior to consent.
- •22.Planned regular concomitant use of barrier contraceptive methods, spermicides, IUDs or other contraceptive measures.
- •23.Evidence or history of clinically significant psychiatric illness, such as major depression or schizop
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