Open-Label, Randomized Study to Evaluate the Influence on the Hormonal and Ovarian Activity of Two Different Dosages of Drospirenone (either 4.0 mg for 24 Days or 2.8 mg Daily for 28 Days) Over Two Treatment Cycles in 50 Healthy, Young Females

Conditions: Evaluation of the influence of Drosperinone on the hormonal and ovarian activity, the bleeding pattern and the endometrial thickness.
MedDRA version: 14.0Level: PTClassification code 10030970Term: Oral contraceptionSystem Organ Class: 10042613 - Surgical and medical procedures
Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

Registration Number: EUCTR2011-004085-15-DE

Lead Sponsor: aboratories León Farma S.A

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: Not specified

Inclusion Criteria

• Healthy premenopausal females of any ethnic origin (18 to 35 years of age), inclusive;
(smokers not older than 30 years, inclusive; smokers = 30 years up to 10 cigarettes daily)

• Body Mass Index (BMI) of 18-30 kg/m2, inclusive

•Subjects must have a history of regular cycles

•Subjects must consent to use reliable non-hormonal contraceptive methods (spermicide-coated condoms, diaphragm, female or male sterilization or sexual abstinence) throughout the study

• Subjects must be in good physical and mental health as determined by vital signs, medical history (no history of a cervical smear PAP =3 within the last year) and gynaecological examination

• Subjects must have a blood pressure after resting for 5 minutes between 90-140 mmHg (systolic) and 50-90 mmHg (diastolic)

• Subjects must have a pulse rate after resting for 5 minutes between 48 and 100 beats per minute (bpm)

• Signed informed consent prior to study participation in accordance with the legal requirements and oral confirmation of the volunteer’s health insurance coverage

• Status at least 3 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 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Pregnancy, a repeatedly positive urine pregnancy test or lactation

• Known or suspected malign tumours or history thereof; subjects with cervical cytological smear classified higher than PAP II according to Papanicolaou grading scale I – IV have to be excluded (PAP II K can be controlled after an anti-inflammatory therapy up to 1 week after ending of this therapy)

• History of thrombophlebitis, venous or arterial thromboembolic diseases (thrombosis, pulmonary embolism, stroke or myocardial infarction)

• Any known severe neurological, gastrointestinal, hepatical or other disease that might interfere with the intake of an investigational drug or any study condition

• Clinical relevant findings from serum biochemistry and haematology and HBsAg/HCV/HIV serology as evaluated by the investigator

• Additional contraindications related to the antimineralocorticoid activity of drospirenone (conditions that predispose to hyperkalaemia): renal or adrenal insufficiency or hepatic dysfunction

• Anovulatory precycle, or no ovulation by day 19 of the precycle, or sonographical pecularities concerning the ovarian status (e.g. ovarian cyst formation, that have not disappeared during the precycle)

• Alcohol, drug, or medicine abuse or suspicion thereof

• Participation in a further clinical trial at the same time or intake of an investigational medicinal product within 4 weeks prior to screening

• Volunteer is a dependent person, e.g. a relative, family member, or member of the investigator’s or sponsor’s staff

• Volunteer is in custody or submitted to an institution due to a judicial order

• Donation of blood or plasmapheresis after signing the informed consent

• Known allergy to any ingredient of the investigational drug

• Regular intake or use of the following medication:
o any drugs that might interfere with the investigational drug
o any hormonal preparation from start of the precycle until the end of treatment cyles (except for the investigational drug)
o especially any drugs known to induce liver enzymes (e.g. rifampicin, dexamethasone, barbiturates, anticonvulsants, St. John’s wort)
o and any drugs known to inhibit CYP 3A4 (e.g. ketoconazole, verapamil, cimetidine, macrolides)
o any broad-spectrum antibiotics
o long-acting injectable or implant hormonal therapy within 6 months prior to the start of the precycle
o use of hormonal implants or IUDs within 1 month prior to the start of screening