Status:
UNKNOWN
Is Cerazette Use Before Nexplanon Insertion Predictive for Bleeding Pattern?
Lead Sponsor:
VL-Medi Oy
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Bleeding
Eligibility:
FEMALE
18-40 years
Phase:
PHASE4
Brief Summary
The purpose of the study is to examine how well three months preceding use of Cerazette progestin only pill predicts the bleeding pattern during following Nexplanon implant use.
Eligibility Criteria
Inclusion
- Healthy women, 18-40 years of age
- regular menstrual cycle (period 23-35 days)
Exclusion
- -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.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT01438736
Start Date
September 1 2011
Last Update
September 22 2011
Active Locations (1)
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1
VL Medi Oy
Helsinki, Finland, 00101