| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Oral contraception for females aged 18-35 |
|
| E.1.1.1 | Medical condition in easily understood language |
| Oral contraception for females aged 18-35 |
|
| E.1.1.2 | Therapeutic area | Body processes [G] - Physiological processes [G07] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 20.0 |
| E.1.2 | Level | SOC |
| E.1.2 | Classification code | 10042613 |
| E.1.2 | Term | Surgical and medical procedures |
| E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 20.0 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10030970 |
| E.1.2 | Term | Oral contraception |
| E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
|
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
| To assess vaginal bleeding pattern (subject paper diaries). |
|
| E.2.2 | Secondary objectives of the trial |
1. Treatment-emergent adverse events (TEAEs)
2. Effects on vital signs and on clinical laboratory parameters
3. Treatment compliance
4. Subject satisfaction
|
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
1. Female subjects aged 18-35 years.
2. Regular cycles during the last three months before consent, when not using hormonal contraception.
3. At least three complete menstrual cycles after delivery/abortion/miscarriage (only applicable for women who were pregnant within the last six months).
4. Body Mass Index (BMI): 18 kg/m2 ≤ BMI <30 kg/m2.
5. Systolic blood pressure < 140 mmHg and diastolic blood pressure < 90 mmHg, in sitting position, after five minutes of rest.
6. Laboratory values with no deviations of any clinical relevance for the course of the trial in the opinion of the investigator.
7. Subjects able to comply with diary entries and protocol requirements.
8. Subject able and willing to provide written informed consent prior to undergoing any trial-related procedures.
9. Subject willing to use an oral contraceptive for two extended 91-day treatment periods.
10. Subject willing to use spermicide-coated condoms (other non-hormonal barrier methods are only allowed at discretion of the investigator) at each sexual intercourse during the trial. |
|
| E.4 | Principal exclusion criteria |
1 Pregnancy, wish for pregnancy or breastfeeding
2 Subject with self-reported heavy vaginal bleeding
3 Subject with relevant uncontrolled concomitant disease
4 Subject is known to or suspected of not being able to comply with the trial protocol, the use of the IMP or the use of the diary
5 Abnormal finding on pelvic, breast or ultrasound examination that in the investigator’s opinion contraindicates participation in the trial
6 History or presence of any malignancy or presence of premalignant disease of the uterus or cervix, including endometrial hyperplasia, or (other) sex-steroid sensitive pre-malignancies
7 Known polycystic ovary syndrome
8 Abnormal cervical smear worse than the Bethesda classification atypical squamous cells of undetermined significance (ASC-US) and positive human papilloma virus (HPV) results at screening. (Cervical smear results from within the previous three months prior to screening will be acceptable if the report is available to the investigator; subjects < 21 years of age do not require a pap smear)
9 Known contraindication or hypersensitivity to ingredients or excipients of the IMP, including:
a. History, presence or suspected risk of a venous thromboembolism (VTE), e.g. deep venous thrombosis (DVT), pulmonary embolism (PE); known hereditary or acquired predisposition for VTE such as activated protein C (APC) resistance or antithrombin III, protein C or protein S deficiency; major surgery with prolonged periods of immobilisation.
b. History, presence or risk of an arterial thromboembolism (ATE), e.g. history of myocardial infarction, angina pectoris, cerebrovascular disease (e.g. current stroke or history of transient ischemic attack), hyperhomocysteinemia, antiphospholipid antibodies, history of migraine with focal neurological symptoms, presence of one of the following serious risk factors: diabetes mellitus with vascular symptoms, severe hypertension, severe dislipoproteinemia
c. Existing or previous pancreatitis, if associated with severe hypertriglyceridemia
d. Presence or history of severe hepatic disease, as long as liver function values have not returned to normal, or liver tumours
e. Severe renal insufficiency or acute renal failure
f. Unexplained vaginal bleeding, irregular menstrual bleeding profile or amenorrhea
g. Presence of more than one of the following risk factors for VTE or ATE: prolonged immobilisation, neurosurgery, surgery to the legs or pelvis, major trauma, positive family history on VTE before 50 years of age, migraine or any other medical conditions associated with VTE or other adverse vascular events
10 Evidence or history of alcohol, medication or drug abuse (within the last 12 months prior to consent)
11 Smokers ≤ 30 years of age, if smoking more than 10 cigarettes per day (up to 10 cigarettes per day will only be allowed if no cardiovascular and metabolic risk factors are met) and any smoker > 30 years of age.
12 Known bleeding disorder or history of unexplained bleeding or bruising within the last 12 months prior to screening
13 Known or suspected human immunodeficiency virus [HIV] and/or hepatitis infection at screening
14 Prohibited previous medication/contraceptives, i.e. injectable hormonal methods of contraception within the last six months prior to consent, progestin-releasing IUD or contraceptive implant within the last two months prior to consent or anti-retroviral therapy within the last six months prior to consent
15 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. Agents increasing the gastrointestinal motility (such as metoclopramide),
b. Agents inducing microsomal enzymes in the liver (such as bosentan, rifampicin, rifabutin, barbiturates, anti-epileptics [e.g. barbexaclon, carbamazepine, oxcarbazepine, phenytoin, primidone, topiramate and felbamate], griseofulvin, modafinil, St. Johns Wort [hypericum perforatum] and HIV medication [e.g. ritonavir, nevirapine and efavirenz]),
c. Aminopenicillins
16 Administration of human chorionic gonadotropin (hCG) or intake of co-medication containing hCG within a month prior to baseline visit
17 Evidence or history of clinically significant psychiatric illness or suicide risk
18 Participation in another trial of an investigational drug or device parallel to the current trial or less than 90 days before consent (calculated from the date of the final examination of the previous trial), or previous participation in the current trial and dispensed trial medication
19 Subject is a dependent person, e.g. a relative, family member, or member of the investigator’s or sponsor’s staff
20 Any condition that, in the opinion of the investigator, may jeopardise protocol compliance or the scientific integrity of the trial
21 Inadequate completion of the training diary i.e. more than two days overall or two consecutive days with missing entries
|
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| The primary endpoint will be evaluated by the total number of bleeding/spotting days. |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
| E.5.2 | Secondary end point(s) |
1. Total number of scheduled bleeding/spotting days
2. Total number of unscheduled bleeding/spotting days
3. Total number of scheduled bleeding/spotting episodes
4. Total number of unscheduled bleeding/spotting episodes
5. Duration of bleeding/spotting episodes
6. Duration of scheduled bleeding/spotting episodes
7. Intensity of bleeding/spotting episodes
8. Rate of absence of all bleeding/spotting
9. Treatment-emergent adverse events (TEAEs)
10. Changes from baseline in vital signs
11. Changes from baseline in clinical laboratory parameters
12. Treatment compliance
13. Subject satisfaction |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | No |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | Yes |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | Yes |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | Yes |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | No |
| E.8.1.5 | Parallel group | No |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 4 |
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 16 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
| Czech Republic |
| Lithuania |
| Ukraine |
|
| E.8.7 | Trial has a data monitoring committee | No |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
| Last Subject Last Visit = end of trial. |
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 1 |
| E.8.9.1 | In the Member State concerned months | 3 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 1 |
| E.8.9.2 | In all countries concerned by the trial months | 3 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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