E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Oral hormonal contraceptive for women without uncontrolled current diseases between 18-45 years. |
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E.1.1.1 | Medical condition in easily understood language |
Oral hormonal contraceptive for women without uncontrolled current diseases between 18-45 years. |
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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 | 13.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10010808 |
E.1.2 | Term | 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 the contraceptive efficacy of LF111 |
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E.2.2 | Secondary objectives of the trial |
To demonstrate the safety and tolerability of LF111 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Women without uncontrolled current diseases at risk of pregnancy, at the age of 18-45 years
2. For starters: At least four menstrual cycles during the last six months before Visit 1a were regular (i.e. cycle length between 24 and 35 days)
3. Systolic blood pressure < 140 mmHg, diastolic blood pressure < 90 mmHg, in sitting position, after 5 minutes of rest
4. Subject agrees to use only IMP for contraception for at least 13 cycles
5. Menstruation restarted since last pregnancy (only applicable for women that were pregnant)
6. Laboratory values with no deviations of any clinical relevance for the course of the study in the opinion of the investigator
7. Written informed consent given freely after the nature of the trial and disclosure of data has been explained to the subject
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E.4 | Principal exclusion criteria |
1. Pregnant subject
2. Breastfeeding subject
3. Subject is known to or suspected of not being able to comply with the study protocol and the use of the IMP
4. Abnormal finding on pelvic, breast or ultrasound examination that precludes participation in the trial
5. Unexplained amenorrhoea, known polycystic ovary syndrome
6. Subject having ASC-US or more severe finding on Pap smear
7. Known contraindication or hypersensitivity to ingredients (drospirenone) or excipients of IMP (cellulose, lactose, silicon dioxide, magnesium stearate, corn starch, polyethylene glycol, polyvinyl pyrrolidone, polyvinyl alcohol, aquariusBT16035 cottage green, talc, titanium dioxide)
8. Significant cardiovascular, hepatic or renal disease, diabetes with vascular involvement, uncontrolled thyroid disorder or current venous thrombosis or embolism
9. Evidence or history of alcohol, medication or drug abuse (within the last 12 months)
10. Known bleeding disorder or history of unexplained bleeding or bruising within the last 12 months prior to V1a
11. Prohibited previous medication / contraceptives ((injectable hormonal methods of contraception within the last 6 months before V1a, progestin-releasing IUD or contraceptive implant within the last 2 months before V1a, anti-retroviral therapy within the last 6 months before V1a)
12. Dependence on prohibited co-medication
13. Planned surgery during the anticipated time of participation in this trial requiring withdrawal of an oral contraceptive
14. Regular concomitant use of barrier contraceptive methods, spermicides, IUDs or other contraceptive measures (excepting occasional use due to risk of infection)
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 90 days before trial entry, or previous participation in this trial
17. Employee of the investigator or trial centre, with direct involvement in the proposed trial or other studies under the direction of that investigator or trial centre, or family member of the employees or the investigator
18. 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) |
Primary efficacy endpoint:
Overall Pearl index (overall PI)
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After study termination (last patient/last visit) |
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E.5.2 | Secondary end point(s) |
Secondary efficacy endpoints:
- Pearl Index for method failures (electronic diaries)
- Pearl Index after correction for back-up contraception
- pregnancy ratio |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
After study termination (last patient/last visit) |
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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 | 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 | Yes |
E.6.13.1 | Other scope of the trial description |
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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 | No |
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
| 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 | 14 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 48 |
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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See protocol section 9.5.1.
The end of the trial is defined as the date of the last visit of the last patient. |
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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 | 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 |