A Pivotal, Multicenter, Non-Comparative Trial on the Contraceptive Efficacy, Safety and Tolerability of Drospirenone as LF111 During 13 Cycles - NA
- Conditions
- Oral hormonal contraceptive for healthy women between 18-45 years.MedDRA version: 12.1Level: LLTClassification code 10010808Term: Contraception
- Registration Number
- EUCTR2010-021787-15-HU
- Lead Sponsor
- aboratorios León Farma S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 700
1.Healthy woman 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.Body-mass-index (BMI) = 30 kg/m2
4.Systolic blood pressure < 140 mmHg, diastolic blood pressure < 90 mmHg, in sitting position, after 5 minutes of rest
5.Subject agrees to use only IMP for contraception for at least 13 cycles
6.Menstruation restarted since last pregnancy (only applicable for women that were pregnant)
7.Laboratory values with no deviations of any clinical relevance for the course of the study in the opinion of the investigator
8.Written informed consent given freely after the nature of the trial and disclosure of data has been explained to the subject
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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 or excipients of IMP
8.Significant cardiovascular, hepatic or renal disease, diabetes with vascular involvement, uncontrolled thyroid disorder or current venous thrombosis
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate the contraceptive efficacy of LF111;Secondary Objective: To demonstrate the safety and tolerability of LF111;Primary end point(s): Primary efficacy endpoint:<br>Overall Pearl index (overall PI)<br>
- Secondary Outcome Measures
Name Time Method