Is Cerazette Use Before Nexplanon Insertion Predictive for Bleeding Pattern?
A Randomized Study to Evaluate the Predictive Impact of Using Cerazette Progestin Only Pill Before Nexplanon Insertion Regarding Bleeding Pattern
2 other identifiers
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 20, 2011
CompletedFirst Posted
Study publicly available on registry
September 22, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedSeptember 22, 2011
September 1, 2011
1.2 years
September 20, 2011
September 21, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The total number of bleeding days per 90 days reference period in women using Cerazette before Nexplanon and in women starting Nexplanon without preceding POP
9 months
Secondary Outcomes (1)
The number of bleeding episodes according to WHO definitions
9 months
Study Arms (2)
Desogestrel, Etonogestrel
EXPERIMENTALArm 1: 75 microgr desogestrel POP (cerazette) daily for 3 months followed by etonogestrel implant (Nexplanon, 68 mg etonogestrel) for following 6 months
Etonogestrel
EXPERIMENTALArm 2: Women staring straight with Nexplanon implant for 6 months
Interventions
Desogestrel 75 micrograms POP daily for 3 monts, followed by etonogestrel 68 mg subdermal implant for following 6 months
Etonogestrel 68 mg subdermal implant for 6 months
Eligibility Criteria
You may qualify if:
- Healthy women, 18-40 years of age
- regular menstrual cycle (period 23-35 days)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- VL-Medi Oylead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (1)
VL Medi Oy
Helsinki, 00101, Finland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dan Apter, Docent
VL-Medi Oy
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2011
First Posted
September 22, 2011
Study Start
September 1, 2011
Primary Completion
November 1, 2012
Last Updated
September 22, 2011
Record last verified: 2011-09