E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Oral contraception for postmenarcheal female adolescents, with or without intact hymen, aged 15-17 and without uncontrolled concomitant disease. |
|
E.1.1.1 | Medical condition in easily understood language |
Oral contraception for healthy young postmenarcheal females, with or without intact hymen, aged 15-17. |
|
E.1.1.2 | Therapeutic area | Body processes [G] - Reproductive physiologi cal processes [G08] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
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 demonstrate safety and tolerability including bleeding pattern. |
|
E.2.2 | Secondary objectives of the trial |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Female adolescents aged 15-17 years, with or without intact hymen. (In some countries the lower age limit may be different due to national legislation.)
2. Subject is postmenarcheal for at least six months.
3. For starters: At least four menstrual cycles during the last six months before Visit 1a were regular.
4. Menstruation restarted since last pregnancy (only applicable for subjects who were pregnant within the last six months), i.e. at least one menstrual cycle after delivery.
5. Systolic blood pressure < 140 mmHg, diastolic blood pressure < 90 mmHg, in sitting position, after 5 minutes of rest.
6. Laboratory values with no deviations of any clinical relevance for the course of the study in the opinion of the investigator.
7. Legal representatives willing to provide written informed consent, and subject able and willing to provide written assent prior to undergoing any trial-related procedures.
|
|
E.4 | Principal exclusion criteria |
1. Body-mass-index (BMI) below the 5th percentile or above the 95th percentile (girls’ BMI-for-age percentiles).
2. Breastfeeding.
3. Subject with 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 gynaecological examination that in the investigator’s opinion contraindicates participation in the trial.
6. Unexplained amenorrhea.
7. Known polycystic ovary syndrome.
8. Known contraindication or hypersensitivity to ingredients or excipients of IMP:
Renal insufficiency, hepatic dysfunction, adrenal insufficiency, thrombophlebitis, current thrombophlebitis or thromboembolic disorders, cerebral-vascular or coronary-artery disease (current or history), valvular heart disease with thrombogenic complications, severe hypertension, diabetes mellitus with vascular involvement, headaches with focal neurological symptoms, major surgery with prolonged immobilisation, known or suspected carcinoma of the breast, carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia, undiagnosed abnormal genital bleeding, cholestatic jaundice of pregnancy or jaundice with prior pill use, known or suspected pregnancy, liver tumor (benign or malignant) or active liver disease.
9. Uncontrolled thyroid disorder (i.e. on stable dose of thyroid hormone replacement therapy for less than two months).
10. Evidence or history of alcohol, medication or drug abuse (within the last 12 months).
11. Known bleeding disorder or history of unexplained bleeding or bruising within the last 12 months prior to V1a.
12. Prohibited previous medication / contraceptives, i.e. injectable hormonal methods of contraception within the last six months, progestin-releasing IUD or contraceptive implant within the last two months or anti-retroviral therapy within the last six months.
13. Regular administration of prohibited co-medication, i.e. estrogens, progestogens, activated charcoal, anticonvulsants (e.g. phenytoin, carbamazepine, oxcarbazepine, topiramate, felbamate, primidone), barbiturates, rifampicin, atorvastatin, bosentan, griseofulvin, phenylbutazon, St. John’s wort (hypericum perforatum), medications that may increase serum potassium (ACE inhibitors, angiotensin – II receptor antagonists, potassium-sparing diuretics, potassium supplementation, heparin, aldosterone antagonists and NSAIDs).
14. Planned surgery during the anticipated time of participation in this trial requiring withdrawal of an oral contraceptive.
15. Evidence or history of neurotic personality, psychiatric illness or suicide risk.
16. Participation in another trial of investigational drugs or devices parallel to, or less than 30 days before trial entry.
17. Previous participation in this trial.
18. Subject is a dependent person, e.g. a relative, family member, or member of the investigator’s or sponsor’s staff.
19. Any condition that, in the opinion of the investigator, may jeopardise the trial conduct according to the protocol.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
1. Treatment-emergent adverse events (TEAEs)
2. Vital signs
3. Clinical laboratory parameters
4. Vaginal bleeding pattern (subject diaries)
5. IMP acceptability
|
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
|
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 | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 5 |
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 |
Finland |
Germany |
Sweden |
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 | 7 |
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 | 7 |
E.8.9.2 | In all countries concerned by the trial days | 0 |