Back to resultsIs Cerazette Use Before Nexplanon Insertion Predictive for Bleeding Pattern?
Primary Purpose
Bleeding
Status
Unknown status
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Desogestrel 75 micrograms POP (Cerazette), Etonogestrel 68 mg implant (Nexplanon)
Etonogestrel 68 mg subdermal implant
Sponsored by
About this trial
This is an interventional diagnostic trial for Bleeding focused on measuring Focus:, preceding, desogestrel predicts, pattern of following, etonogestrel implant
Eligibility Criteria
Inclusion Criteria:
- Healthy women, 18-40 years of age
- regular menstrual cycle (period 23-35 days)
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.
Sites / Locations
- VL Medi Oy
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Desogestrel, Etonogestrel
Etonogestrel
Arm Description
Arm 1: 75 microgr desogestrel POP (cerazette) daily for 3 months followed by etonogestrel implant (Nexplanon, 68 mg etonogestrel) for following 6 months
Arm 2: Women staring straight with Nexplanon implant for 6 months
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
The number of bleeding episodes according to WHO definitions
Full Information
NCT ID
NCT01438736
First Posted
September 20, 2011
Last Updated
September 21, 2011
Sponsor
VL-Medi Oy
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT01438736
Brief Title
Is Cerazette Use Before Nexplanon Insertion Predictive for Bleeding Pattern?
Official Title
A Randomized Study to Evaluate the Predictive Impact of Using Cerazette Progestin Only Pill Before Nexplanon Insertion Regarding Bleeding Pattern
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Unknown status
Study Start Date
September 2011 (undefined)
Primary Completion Date
November 2012 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VL-Medi Oy
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bleeding
Keywords
Focus:, preceding, desogestrel predicts, pattern of following, etonogestrel implant
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Desogestrel, Etonogestrel
Arm Type
Experimental
Arm Description
Arm 1: 75 microgr desogestrel POP (cerazette) daily for 3 months followed by etonogestrel implant (Nexplanon, 68 mg etonogestrel) for following 6 months
Arm Title
Etonogestrel
Arm Type
Experimental
Arm Description
Arm 2: Women staring straight with Nexplanon implant for 6 months
Intervention Type
Drug
Intervention Name(s)
Desogestrel 75 micrograms POP (Cerazette), Etonogestrel 68 mg implant (Nexplanon)
Intervention Description
Desogestrel 75 micrograms POP daily for 3 monts, followed by etonogestrel 68 mg subdermal implant for following 6 months
Intervention Type
Drug
Intervention Name(s)
Etonogestrel 68 mg subdermal implant
Intervention Description
Etonogestrel 68 mg subdermal implant for 6 months
Primary Outcome Measure Information:
Title
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
Time Frame
9 months
Secondary Outcome Measure Information:
Title
The number of bleeding episodes according to WHO definitions
Time Frame
9 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy women, 18-40 years of age
regular menstrual cycle (period 23-35 days)
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dan Apter, Docent
Phone
+358405550842
Email
dan.apter@vaestoliitto.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan Apter, Docent
Organizational Affiliation
VL-Medi Oy
Official's Role
Principal Investigator
Facility Information:
Facility Name
VL Medi Oy
City
Helsinki
ZIP/Postal Code
00101
Country
Finland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dan Apter, docent
12. IPD Sharing Statement
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Is Cerazette Use Before Nexplanon Insertion Predictive for Bleeding Pattern?
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