EUCTR2019-001876-12-BG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11月25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 15 and 45 years (inclusive) at the time of trial enrolment. (In some countries the lower age limit may be higher due to national legislation.)
- •Female subjects at risk of pregnancy, between the ages of 15 and 17 (inclusive) provided that:
- •a.Applicable national, state and local laws allow subjects in this age group to consent/assent to receive contraceptive services,
- •b.All applicable laws and regulations regarding the informed consent/assent of the subjects to participate in clinical trials are observed.
- •2.Women who
- •a.have never used hormonal contraceptives before consent/assent (naïve users),
- •b.have used hormonal contraceptives in the past, but have had a hormonal contraceptive-free period before consent/assent 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/assent: 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/assent: 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/assent, 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? yes
- •Number of subjects for this age range: 50
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 800
- •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 amenorrhoea
- •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 assent/consent).
- •12.Uncontrolled concomitant diseases (i.e., not on a stable treatment dose for at least two months at the time of assent/consent).
- •13.Evidence or history of alcohol, medication or drug abuse (within the last 12 months prior to consent/assent).
- •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/assent.
- •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 oestrogens, 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/assent.
- •22.Planned regular concomitant use of barrier contraceptive methods, spermicides, IUDs or other contraceptive measures.
- •23.Evidence or history of clinically significant psychiatric illness
研究者
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