A clinical study for testing the contraceptive efficacy, tolerability and safety of dienogest 2 mg / ethinyl estradiol 0.02 mg during nine cycles in comparison with drospirenone 3 mg / ethinyl estradiol 0.02 mg

Phase 1

Conditions: Oral contraception for females aged 18-45
MedDRA version: 20.0Level: SOCClassification code 10042613Term: Surgical and medical proceduresSystem Organ Class: 10042613 - Surgical and medical procedures
MedDRA version: 21.1Level: PTClassification code 10030970Term: Oral contraceptionSystem Organ Class: 10042613 - Surgical and medical procedures
Therapeutic area: Body processes [G] - Physiological processes [G07]

Registration Number: EUCTR2019-001877-97-SK

Lead Sponsor: Chemo Research S.L.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: 1018

Inclusion Criteria

1.Sexually active, postmenarcheal and premenopausal female subjects, at risk of pregnancy, aged between 18-45 years (inclusive) at the time of trial enrolment.
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 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 nine 28-day cycles.
8.Be willing to have intercourse in each cycle of the trial without the need to use back-up contraception.
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 1018
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.Body Mass Index (BMI) < 18 kg/m2 or BMI >30 kg/m2.
7.Current smokers with age > 35 years (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 of squamous intraepithelial lesion (LGSIL) or higher at screening (or six months prior to screening date). Subjects with ASC-US can be included if they are negative for high-risk 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, genital organs or endometrium)
g.Undiagnosed vaginal bleeding
h.Unexplained amenorrhoea
i.Concomitant use of medicinal products containing ombitasvir / paritaprevir / ritonavir or dasabuvir
j.Severe renal insufficiency or acute renal failure.
11.Uncontrolled thyroid disorder (i.e., not on stable dose of thyroid replacement for at least than 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 rifampicin [tuberculosis infection], griseofulvin [fungal infections])
d.HIV medication (such as ritonavir, neviparine and efavirenz)
e.Bosentan
f.St. Johns wort (hypericum perforatum)
g.Metoclopramide
19.Prohibited medication including the use of oestrogens, progestogens, strong microsomal enzyme-inducing drugs (intensive and moderate frequency).
20.Prohibited medications that may increase serum potassium (angiotensin-converting enzyme [ACE] inhibitors, angiotensin II receptor antagonists, potassium-sparing diuretics, potassium supplementation, heparin and aldosterone antagonists).
21.Administration of medication containing human chorionic gonadotropin (hCG) within a month prior to V1b.
22.Progestin-releasing intra-uterine device (IUD) or contraceptive implant received or in place within the last two months prior to consent.
23.Pla

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate the contraceptive efficacy of LPRI-424;Secondary Objective: To demonstrate the safety and tolerability of LPRI 424 in comparison to DRSP 3 mg / EE 0.02 mg, especially regarding bleeding pattern;Primary end point(s): Overall Pearl Index (PI) in women aged = 35 years (at the time of trial<br>enrolment);Timepoint(s) of evaluation of this end point: After trial termination

Secondary Outcome Measures

Name	Time	Method

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