one

• Conditions: Evaluation of ovulation inhibition with scheduled 24h delay in pill intake in healty young females of child bearing potential.; MedDRA version: 14.1Level: PTClassification code 10030970Term: Oral contraceptionSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

• Registration Number: EUCTR2013-001513-33-DE
• Lead Sponsor: aboratorios León Farma S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-06
• Last Update Posted: 5 August 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

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.

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 180
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.;Secondary Objective: 1. To assess bleeding pattern<br>2. To evaluate safety and tolerability ;Primary end point(s): Ovulation incidence, defined as percentage of subjects ovulating during treatment period;Timepoint(s) of evaluation of this end point: The primary endpoint is scheduled to be evaluated at the end of the trial (2014).

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Bleeding pattern<br>- Treatment Emergent Adverse Events<br>- Vital signs<br>- Clinical laboratory parameters;Timepoint(s) of evaluation of this end point: The secondary endpoints are scheduled to be evaluated at the end of the trial (2014).