- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01438736
Is Cerazette Use Before Nexplanon Insertion Predictive for Bleeding Pattern?
September 21, 2011 updated by: VL-Medi Oy
A Randomized Study to Evaluate the Predictive Impact of Using Cerazette Progestin Only Pill Before Nexplanon Insertion Regarding Bleeding Pattern
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.
Study Overview
Status
Unknown
Conditions
Study Type
Interventional
Enrollment (Anticipated)
90
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Dan Apter, Docent
- Phone Number: +358405550842
- Email: dan.apter@vaestoliitto.fi
Study Locations
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Helsinki, Finland, 00101
- VL Medi Oy
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Principal Investigator:
- Dan Apter, docent
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Desogestrel, Etonogestrel
Arm 1: 75 microgr desogestrel POP (cerazette) daily for 3 months followed by etonogestrel implant (Nexplanon, 68 mg etonogestrel) for following 6 months
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Desogestrel 75 micrograms POP daily for 3 monts, followed by etonogestrel 68 mg subdermal implant for following 6 months
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Experimental: Etonogestrel
Arm 2: Women staring straight with Nexplanon implant for 6 months
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Etonogestrel 68 mg subdermal implant for 6 months
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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9 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The number of bleeding episodes according to WHO definitions
Time Frame: 9 months
|
9 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Dan Apter, Docent, VL-Medi Oy
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2011
Primary Completion (Anticipated)
November 1, 2012
Study Registration Dates
First Submitted
September 20, 2011
First Submitted That Met QC Criteria
September 21, 2011
First Posted (Estimate)
September 22, 2011
Study Record Updates
Last Update Posted (Estimate)
September 22, 2011
Last Update Submitted That Met QC Criteria
September 21, 2011
Last Verified
September 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Hemorrhage
- Physiological Effects of Drugs
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptives, Oral
- Contraceptive Agents, Female
- Contraceptives, Oral, Synthetic
- Contraceptives, Oral, Hormonal
- Progestins
- Desogestrel
- Etonogestrel
Other Study ID Numbers
- EudraCT 2011-001492-39
- IIPS#39689 (Other Grant/Funding Number: Merck)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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