A clinical study for testing safety and tolerability of 4.0 mg Drospirenone (LF111) during 6 cycles at several study sites with the possibility of a trial extension for further 7 cycles

• Conditions: Oral contraception for postmenarcheal female adolescents, with or without intact hymen, aged 12-17 and without uncontrolled concomitant disease.; MedDRA version: 16.1Level: PTClassification code 10030970Term: Oral contraceptionSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]

• Registration Number: EUCTR2013-005234-37-NL
• Lead Sponsor: aboratorios León Farma S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02-10
• Last Update Posted: 31 March 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 130

Inclusion Criteria

1. Female adolescents aged 12-17 years, with or without intact hymen. (In some countries the lower age limit may be higher due to national legislation.)
2. Subject is postmenarcheal for at least six months.
3. For starters: At least four menstrual cycles during the last six months before Visit 1a were regular.
4. Menstruation restarted since last pregnancy (only applicable for subjects who were pregnant within the last six months), i.e. at least one menstrual cycle after delivery.
5. Systolic blood pressure < 140 mmHg, diastolic blood pressure < 90 mmHg, in sitting position, after 5 minutes of rest.
6. Laboratory values with no deviations of any clinical relevance for the course of the study in the opinion of the investigator.
7. Legal representatives willing to provide written informed consent, and subject able and willing to provide written assent prior to undergoing any trial-related procedures.
8. Subject willing to use an oral contraceptive for at least six cycles.

Are the trial subjects under 18? yes
Number of subjects for this age range: 130
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1. Body-mass-index (BMI) below the 5th percentile or above the 95th percentile (girls’ BMI-for-age percentiles).
2. Breastfeeding.
3. Subject with uncontrolled concomitant disease.
4. Subject is known to or suspected of not being able to comply with the trial protocol, the use of the IMP or the use of the diary.
5. Abnormal finding on gynaecological examination that in the investigator’s opinion contraindicates participation in the trial.
6. Unexplained amenorrhea.
7. Known polycystic ovary syndrome.
8. Known contraindication or hypersensitivity to ingredients or excipients of IMP:
Renal insufficiency, hepatic dysfunction, adrenal insufficiency, thrombophlebitis, current thrombophlebitis or thromboembolic disorders, cerebral-vascular or coronary-artery disease (current or history), valvular heart disease with thrombogenic complications, severe hypertension, diabetes mellitus with vascular involvement, headaches with focal neurological symptoms, major surgery with prolonged immobilisation, known or suspected carcinoma of the breast, carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia, undiagnosed abnormal genital bleeding, cholestatic jaundice of pregnancy or jaundice with prior pill use, known or suspected pregnancy, liver tumor (benign or malignant) or active liver disease.
9. Uncontrolled thyroid disorder (i.e. on stable dose of thyroid hormone replacement therapy for less than two months).
10. Evidence or history of alcohol, medication or drug abuse (within the last 12 months).
11. Known bleeding disorder or history of unexplained bleeding or bruising within the last 12 months prior to V1a.
12. Prohibited previous medication / contraceptives, i.e. injectable hormonal methods of contraception within the last six months, progestin-releasing IUD or contraceptive implant within the last two months or anti-retroviral therapy within the last six months.
13. Regular administration of prohibited co-medication, i.e. estrogens, progestogens, activated charcoal, anticonvulsants (e.g. phenytoin, carbamazepine, oxcarbazepine, topiramate, felbamate, primidone), barbiturates, rifampicin, atorvastatin, bosentan, griseofulvin, phenylbutazon, St. John’s wort (hypericum perforatum), medications that may increase serum potassium (ACE inhibitors, angiotensin – II receptor antagonists, potassium-sparing diuretics, potassium supplementation, heparin, aldosterone antagonists and NSAIDs).
14. Planned surgery during the anticipated time of participation in this trial requiring withdrawal of an oral contraceptive.
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 30 days before trial entry.
17. Previous participation in this trial.
18. Subject is a dependent person, e.g. a relative, family member, or member of the investigator’s or sponsor’s staff.
19. 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 safety and tolerability including bleeding pattern.;Secondary Objective: Not applicable.;Primary end point(s): 1. Treatment-emergent adverse events (TEAEs)<br>2. Vital signs<br>3. Clinical laboratory parameters <br>4. Vaginal bleeding pattern during treatment cycles 1-6 (subject diaries)<br>5. IMP acceptability <br>;Timepoint(s) of evaluation of this end point: After trial termination.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Not applicable.;Timepoint(s) of evaluation of this end point: Not applicable.