E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Evaluation of ovulation inhibition with scheduled 24h delay in pill intake in healty young females of child bearing potential. |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Body processes [G] - Metabolic Phenomena [G03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
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 |
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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 that ovulation inhibition with LF111 (drospirenone 4.0 mg 24/4 regimen) is maintained in spite of scheduled 24-hour delays in pill intake. |
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E.2.2 | Secondary objectives of the trial |
1. To assess bleeding pattern
2. To evaluate safety and tolerability |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Healthy premenopausal females of any ethnic origin without regular intake of medicine, 18 to 35 years of age, inclusive. Smokers not older than 30 years, inclusive (up to 10 cigarettes daily).
2. Subjects must consent to use reliable non-hormonal contraceptive methods (condoms, diaphragm, female or male sterilisation or sexual abstinence) throughout the trial.
3. Subjects must be in good physical and mental health as determined by vital signs, medical history, physical examination, gynaecological examination, cervical smear, urinalysis, serum biochemistry, HBsAg/HCV/HIV serology, and haematology .
4. Subjects must have a blood pressure after resting for 5 minutes of 90-140 mmHg (systolic) and 50-90 mmHg (diastolic) and a pulse rate of 50-90 beats per minute (bpm).
5. Subjects must have voluntarily signed informed consent.
6. Status at least three months after a delivery, abortion, or lactation before screening.
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E.4 | Principal exclusion criteria |
1. Pregnancy, a positive urine pregnancy test or lactation.
2. Known or suspected malign tumours or history thereof; subjects with cervical cytological smear classified higher than PAP II according to Papanicolaou grading scale I –V have to be excluded (PAP II K can be rechecked after an anti-inflammatory therapy up to 4 weeks after start of this therapy).
3. Thrombophlebitis, venous or arterial thromboembolic diseases (thrombosis, pulmonary embolism, stroke or myocardial infarction) or other conditions that increase susceptibility to thromboembolic diseases (e.g. prolonged immobilisation, disturbance of the coagulation system or thromboembolic diseases in a close relative at young age, certain heart diseases).
4. Any known severe neurological, gastrointestinal, hepatic or other disease that might interfere with the intake of IMP or any trial condition, (e.g. lactose intolerance).
5. Additional contraindications related to the antimineralocorticoid activity of drospirenone (conditions that predispose to hyperkalaemia): renal or adrenal insufficiency or hepatic dysfunction.
6. Anovulatory precycle or sonographical peculiarities concerning the ovarian status (e.g. ovarian cyst formation that has not disappeared during the precycle).
7. Alcohol, drug, or medicine abuse or suspicion thereof.
8. Participation in a further clinical trial at the same time or intake of an investigational medicinal product within 4 weeks prior to screening.
9. Subject is a dependent person, e.g. a relative, family member, or member of the investigator’s or sponsor’s staff.
10. Subject in custody or submitted to an institution due to a judicial order.
11. Donation of blood or plasmapheresis after signing the informed consent.
12. Known allergy to any ingredients of the IMP.
13. Intake of the following medication:
a. Any drugs that might interfere with the trial objectives.
b. Especially any drugs known to induce liver enzymes (e.g. rifampicin, dexamethasone, barbiturates, anticonvulsants, St. John’s wort).
c. Any drugs known to inhibit CYP3A4 (e.g. ketoconazole, verapamil, cimetidine, macrolides).
d. Use of sex steroids during the cycle prior to the start of the precycle until after progesterone sampling in the follow-up phase (except for IMP in the treatment cycles).
e. Use of long-acting injectable or implant hormonal therapy within 6 months prior to the start of screening.
f. Use of hormonal or non-hormonal intra-uterine devices (IUDs) within 1 month prior to the start of screening.
g. Anti-retroviral therapy within 6 months before screening.
14. Planned major surgery with prolonged immobilisation during the anticipated time of participation in this trial.
15. Any condition that, in the opinion of the investigator, may jeopardise the trial conduct according to the protocol. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Ovulation incidence, defined as percentage of subjects ovulating during treatment period |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The primary endpoint is scheduled to be evaluated at the end of the trial (2014). |
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E.5.2 | Secondary end point(s) |
- Bleeding pattern
- Treatment Emergent Adverse Events
- Vital signs
- Clinical laboratory parameters |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
The secondary endpoints are scheduled to be evaluated at the end of the trial (2014). |
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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 | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
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) | 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 | 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 | Yes |
E.8.1.7.1 | Other trial design description |
Group allocation in alternating pattern depending on day of ovulation in precycle. |
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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 | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
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
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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 | 1 |
E.8.9.1 | In the Member State concerned days | 0 |