Oral contraception for females aged 18-45 MedDRA version: 20.0 Level: SOC Classification code 10042613 Term: Surgical and medical procedures System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 21.1 Level: PT Classification code 10030970 Term: Oral contraception System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Sponsors
Chemo Research S.L.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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) or 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
Exclusion criteria
Exclusion criteria: 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) e.Bosentan 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the contraceptive efficacy of LPRI-424;Secondary Objective: To demonstrate the safety and tolerability of LPRI-424 and to assess the pharmacokinetics of LPRI-424;Primary end point(s): Overall Pearl Index (PI) in women aged = 35 years (at the time of trial enrolment) ;Timepoint(s) of evaluation of this end point: After trial termination | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary: 1.PI after correction for back-up contraception and sexual activity (evaluable cycles) in women aged = 35 years (at the time of trial enrolment) 2.PI for method failures in women aged = 35 years (at the time of trial enrolment) 3.Pregnancy ratio (life table analysis) in women aged = 35 years (at the time of trial enrolment) 4.Overall PI, PI after correction for back-up contraception and sexual activity (evaluable cycles), PI for method failures and pregnancy ratio (life table analysis) in all women 5.Overall PI, PI after correction for back-up contraception and sexual activity (evaluable cycles), PI for method failures and pregnancy ratio (life table analysis) in women aged > 35 years (at the time of trial enrolment) Safety/Tolerability: 6.Adverse events (AEs) 7.Vital signs 8.Electrocardiogram (ECG) 9.Physical examination 10.Gynaecological examination 11.Transvaginal ultrasound examination 12.Mastodynia/mastalgia and dysmenorrhea characteristics as well as cervical cytology 13.Clinical laboratory parameters 14.Vaginal bleeding pattern 15.IMP acceptability 16.Quality of Life Enjoyment and Satisfaction Questionnaire – Short Form (Q-LES-Q-SF) Pharmacokinetics (PK): 17.LPRI-424 (DNG and EE) plasma concentrations 18.Volume of distribution 19.Apparent clearance 20.Area under the curve (AUC);Timepoint(s) of evaluation of this end point: After trial termination | — |
Countries
Bulgaria, Czech Republic, Germany, Lithuania, Portugal, Spain, Ukraine
Contacts
Public ContactChief Scientific Officer
Chemo Research S.L.
Outcome results
None listed