This study is a pilot study to test the effect of Cerazette minipill use before Nexplanon implant insertion to predict the bleeding pattern. The total subject number of 90, divided into two arms of about 45 is predicted to be suitable to be able to detect the changes in the bleeding pattern. Descriptive statistics will be used.
Conditions
Interventions
Trade Name: Cerazette
Product Name: Cerazette
Pharmaceutical Form: Coated tablet
INN or Proposed INN: DESOGESTREL
CAS Number: 54024-22-5
Trade Name: Nexplanon
Product Name: Nexplanon
Pharmaceutical F
Sponsors
Vl-Medi Oy, Väestöliitto
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy women of fertile age, 15-40 years of age, with regular menstrual cycles (period 23-35). 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 90 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Immediate previous use of progestin only contraception within 2 months - Known or suspected pregnancy - Acute tromboembolic disorder - Presence or history of hepatic disease, as long as the liver function values have not returned to normal - Undiagnosed vaginal bleeding - Known or suspected sex-steroid influenced malignancies (e.g. breast cancer) - Hypersensitivity to the active substances or to any of the excipients of the medicines - Pregnant or breast feeding within 6 weeks - The use of other medicinal products that might interact with contraceptive steroids and affect the efficacy of contraceptives and/or might may lead to bleeding irregularities (especially medicines that induce the liver enzyme systems such as cytochrome P450). Examples of active substances are: phenytoin, phenobarbital, primidone, bosentan, carbamatzepine, rifampicin and medicinal products or herbal preparations containing ST.John's wort and to a lesser extend oxcarbazepine, topiramate, felbamate and griseofulvin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To examine how well 3 month preceding use of Cerazette predicts the bleeding pattern during the first 6 months of use of Nexplanon. ;Secondary Objective: To examine how well 3 month preceding use of Cerazette predicts adverse events and well-being during later Nexplanon use.;Primary end point(s): The primary endpoint will be the total number of bleeding days per 90 days reference period. ;Timepoint(s) of evaluation of this end point: Bleeding patters during all five 90 day periods will be compared. Please see protocol for further details | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints will be number of bleeding episodes and frequency of prolonged bleeding according to WHO definitions. ;Timepoint(s) of evaluation of this end point: Adverse events will be analyzed as well as the acceptance of the method. Well-being questionnaires will be used. | — |
Countries
Finland
Contacts
Public ContactVL-Medi
VL-Medi, Väestöliitto
Outcome results
None listed