The aim of the present study is to examine the overall satisfaction with and tolerability of LCS12 compared with a standard combined oral contraceptive (COC
Conditions
Sponsors
Bayer HealthCare AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subject has signed and dated the Informed Consent Form (ICF). - The subject is generally healthy, requesting contraception, and is between 18 and 29 years of age (inclusive) at Screening. - In the opinion of the investigator, the subject is -- in good health; -- without uterine conditions that would preempt insertion of LCS12; -- without conditions/history that would contraindicate the use of oral contraceptives. - Subject has normal or clinically insignificant cervical smear (ie, one that does not require further follow up). A cervical smear must be taken at the Screening Visit or a documented normal result has to have been obtained within 6 months of Screening. Subjects with atypical squamous cells of undetermined significance (ASCUS) can be included in the study if they have a Human Papilloma Virus (HPV) deoxyribonucleic acid (DNA) test that, according to the standards of the local laboratory, is negative for high-risk HPV. - As determined by subject’s history, subject has regular (ie, endogenous cyclicity without hormonal contraceptive use) menstrual cycles (length of cycle 21-35 days). - Subject is willing and able to attend the scheduled study visits and to comply with the study procedures. 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 550 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Pregnancy or current lactation (less than 6 weeks since vaginal or Cesarean delivery or abortion). Postpartum LCS12 insertions should be postponed until the uterus is fully involuted, and not earlier than 6 weeks after delivery. If involution is substantially delayed, the investigator should consider waiting until 12 weeks postpartum. - Infected abortion or postpartum endometritis within 3 months prior to the Screening Visit (Visit 1). - Chronic, daily use of drugs that may increase serum potassium levels, such as nonsteroidal anti-inflammatory drugs (NSAIDs, eg. ibuprofen and naproxen), potassium-sparing diuretics (eg. spironolactone), potassium supplementation, angiotensin converting enzyme (ACE) inhibitors, angiotensin-II receptor antagonists, aldosterone antagonists, and heparin. - Abnormal uterine bleeding of unknown origin/undiagnosed abnormal genital bleeding - Any genital infection (until successfully treated). - Abnormal cervical smear result (see inclusion criterion 4) - Acute, current, or history of recurrent pelvic inflammatory disease. - Congenital or acquired uterine anomaly or any distortion of the uterine cavity (eg, by fibroids) that, in the opinion of the investigator, would cause problems during insertion, retention, or removal of LCS12. -History of diagnosed,or suspected genital malignancy, and untreated cervical dysplasia. -History of migraine with focal neurological symptoms. -Vascular diseases and coagulation disorders, including presence or history of venous thromboembolic diseases (eg, deep vein thrombosis, pulmonary embolism), presence or history of arterial thromboembolic diseases (eg, myocardial infarction, stroke), and any condition that could increased increase the risk of suffering from any of the above mentioned disorders (eg, a positive family history [event that occurred in a sibling or parent at an early age] or a known or suspected hereditary predisposition). -Clinically significant endometrial polyp(s) that, in the opinion of the investigator, may interfere with the assessment of the bleeding profile during the study. -Clinically significant ovarian cyst (defined as abnormal non-functional cysts) based on the investigator’s clinical judgment. -Established immunodeficiency. -Diabetes mellitus with vascular involvement. -Severe renal insufficiency or acute renal failure. -Any known hypersensitivity to the constituents of LCS12 or COC (Yasmin). -Diagnosed or suspected malignant or premalignant disease at the Screening Visit (Visit 1). -Arterial hypertension not responding to treatment, with systolic pressure >140 mm Hg or diastolic pressure >90 mm Hg. -History of or current severe hepatic diseases, including benign or malignant tumors. An interval of at least 3 months between the return to normal liver function values and the start of study treatment (ie, LCS12 insertion or ingestion of first COC pill) should be observed. -History of chronic alcoholism, drug dependence or abuse, psychotic states, severe neurosis, or any other condition that, in the judgment of the investigator, may impair the subject's ability to cooperate with the conditions of this protocol. -Known or suspected infection with the human immunodeficiency virus or, in the investigator’s judgment, is at high risk for sexually transmitted diseases (STDs).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate user satisfaction in young nulliparous and parous women (18-29 years of age) using LCS12 compared with young nulliparous and parous women using a COC over a period of 18 months. ;Secondary Objective: Secondary objectives are to determine the tolerability, discontinuation rates, AE profiles, occurrences of unintended pregnancies (including calculation of PI), and bleeding profiles. Additionally, data on missed tablets in the COC group, and IUS expulsions in the LCS12 group will be recorded. ;Primary end point(s): The primary efficacy variable is the overall satisfaction rate, by treatment group, at the end of the comparative phase of the study (or at early termination for those subjects discontinuing the study before completion of the 18-month comparative phase). Satisfaction will be assessed by the subject based on a 5-point Likert item, using the following question: o How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied ;Timepoint(s) of evaluation of this end point: At the end of the comparative phase of the study (or at the early termination for those subjects discontinuing the study before completion of the 18-month comparative phase). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy variables will include: o Frequency of each possible answer (1 to 5) on the Likert item at 6, 12, and 18 months. o Overall satisfaction rates, by treatment group, at 6 and 12 months. o Pearl index o Modified EVAPIL scale at Baseline, 6, 12, and 18 months. o User satisfaction and bleeding questionnaire at 6, 12 and 18 months. o Discontinuation rates, by treatment group at 6, 12, and 18 months. o Diary data for pill intake ;Timepoint(s) of evaluation of this end point: At 6, 12 and 18 months | — |
Countries
Austria, Belgium, Germany, United States
Contacts
Public ContactCTP team/Ref: "EU CTR"/S102-Room 15
Bayer HealthCare AG
Outcome results
None listed