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Conditions: Evaluation of the influence on the ovarian activity, the cervix score, the bleeding pattern and the endometrial thickness in healthy young females.
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: EUCTR2010-024546-30-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) without regular intake of medicine
• Body Mass Index (BMI) of 18-30 kg/m2, inclusive
• 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, physical examination, gynaecological examination, cervical smear, urinalysis, serum biochemistry, HBsAg/HCV/HIV serology, and haematology
• Subjects must have a blood pressure after resting for 5 minutes between 90-140 mmHg (systolic) and 50-90 mmHg (diastolic) and a pulse rate of = 100 beats per minute (bpm)
• Subjects must have voluntarily signed informed consent
• 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: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Pregnancy, a 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 – V have to be excluded (PAP II K can be controlled after an anti-inflammatory therapy up to 4 weeks after start of this therapy)
• 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 immobilization, disturbance of the coagulation system or thromboembolic diseases in a close relative at young age, certain heart diseases)
• Any known severe neurological, gastrointestinal, hepatic or other disease that might interfere with the intake of an investigational drug or any study condition, e.g. lactose-intolerance
• Additional contraindications related to the antimineralocorticoid activity of drospirenone (conditions that predispose to hyperkalaemia): renal or adrenal insufficiency or hepatic dysfunction
• Anovulatory precycle or sonographical peculiarities 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 study 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 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 ingredients of the investigational drug or reference drug
• Intake of the following medication:
- any drugs that might interfere with the study objectives
- especially any drugs known to induce liver enzymes (e.g. rifampicin, dexamethasone, barbiturates, anticonvulsants, St. John’s wort)
- any drugs known to inhibit CYP 3A4 (e.g. ketoconazole, verapamil, cimetidine, macrolides)
- use of sex steroids during the cycle prior to the start of the precycle until the end of the post-treatment cycle (except for the study medication in the treatment cycles)
- use of long-acting injectable or implant hormonal therapy within 6 months prior to the start of precycle
- use of hormonal or non-hormonal IUDs within 1 month prior to the start of screening

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: The primary endpoint is scheduled to be evaluated at the end of the trial (2012).;Main Objective: To assess the ovulation inhibition potential as reflected by the ovarian activity (follicular growth, estradiol and progesterone serum concentrations) of Drospirenone (DRSP) in comparison to desogestrel, contained in the marketed progesterone only pill CERAZET®, in 60 healthy women;Secondary Objective: 1. To assess the influence on the cervix condition, the bleeding pattern, the endometrial thickness, and the pituitary hormones<br><br>2. To evaluate the safety and tolerability of 4.0 mg DRSP once daily over 24 days given over 2 treatment cycles<br><br>3. To evaluate the return of ovulation in a post-treatment cycle<br>;Primary end point(s): 1. Hoogland Score<br>2. Landgren Score (if applicable)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Cervix condition by Insler Score<br>2. The bleeding pattern<br>3. Endometrium thickness as determined by transvaginal ultrasound (TVUS)<br>4. Determination of the pituitary hormones LH and FSH<br>5. Safety examinations as determined by inquiry of adverse events,<br>vital signs measurements, pregnancy tests, safety laboratory, physical and gynaecological examinations<br>6. Measurement of the leading follicle during the posttreatment-cycle every 3rd day ±1day until ovulation or day 27 (whatever comes first) by TVUS and subsequent confirmation by serum progesterone to confirm the return of ovulation;Timepoint(s) of evaluation of this end point: The secondary endpoints are scheduled to be evaluated at the end of the trial (2012).