BleedingPhase 4NCT01438736
Is Cerazette Use Before Nexplanon Insertion Predictive for Bleeding Pattern?
A Phase 4 study testing Desogestrel 75 micrograms POP (Cerazette), Etonogestrel 68 mg implant (Nexplanon) and Etonogestrel 68 mg subdermal implant in people with Bleeding, run by VL-Medi Oy at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bleeding
- What is being tested?
- Desogestrel 75 micrograms POP (Cerazette), Etonogestrel 68 mg implant (Nexplanon) and Etonogestrel 68 mg subdermal implant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteFinland
- Study dates
- Sep 2011to Nov 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy women, 18-40 years of age
- regular menstrual cycle (period 23-35 days)
Who cannot join
- -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)
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Bleeding
- Being tested
- Desogestrel 75 micrograms POP (Cerazette), Etonogestrel 68 mg implant (Nexplanon), Etonogestrel 68 mg subdermal implant
- Keywords
- Focus:, preceding, desogestrel predicts, pattern of following, etonogestrel implant
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Desogestrel 75 micrograms POP (Cerazette), Etonogestrel 68 mg implant (Nexplanon)Drug
Desogestrel 75 micrograms POP daily for 3 monts, followed by etonogestrel 68 mg subdermal implant for following 6 months
Etonogestrel 68 mg subdermal implantDrug
Etonogestrel 68 mg subdermal implant for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Desogestrel, Etonogestrel | Experimental | Arm 1: 75 microgr desogestrel POP (cerazette) daily for 3 months followed by etonogestrel implant (Nexplanon, 68 mg etonogestrel) for following 6 months Receives: Drug: Desogestrel 75 micrograms POP (Cerazette), Etonogestrel 68 mg implant (Nexplanon) |
| Etonogestrel | Experimental | Arm 2: Women staring straight with Nexplanon implant for 6 months Receives: Drug: Etonogestrel 68 mg subdermal implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 9 months
Secondary outcomes (1)
The number of bleeding episodes according to WHO definitions
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionNov 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VL-Medi Oy
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Dan Apter, Docent, Principal investigator, VL-Medi Oy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01438736
- Sponsor's protocol ID
- EudraCT 2011-001492-39
- Other IDs
- IIPS#39689
- Status last verified
- Sep 2011
- First submitted
- 20 Sep 2011
- Last updated
- 22 Sep 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study to Evaluate the Predictive Impact of Using Cerazette Progestin Only Pill Before Nexplanon Insertion Regarding Bleeding Pattern
- ClinicalTrials.gov ID
- NCT01438736
- Acronym / sponsor ID
- EudraCT 2011-001492-39
- Conditions
- Bleeding
- Keywords
- Focus:, preceding, desogestrel predicts, pattern of following, etonogestrel implant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- VL-Medi OyUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Sep 2011
- Primary completion
- Nov 2012 (estimated)
- First posted
- 22 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Desogestrel, Etonogestrel | Experimental | Drug: Desogestrel 75 micrograms POP (Cerazette), Etonogestrel 68 mg implant (Nexplanon)Arm 1: 75 microgr desogestrel POP (cerazette) daily for 3 months followed by etonogestrel implant (Nexplanon, 68 mg etonogestrel) for following 6 months |
| Etonogestrel | Experimental | Drug: Etonogestrel 68 mg subdermal implantArm 2: Women staring straight with Nexplanon implant for 6 months |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy women, 18-40 years of age
- regular menstrual cycle (period 23-35 days)
Key exclusion criteria (9 listed)
- -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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Desogestrel 75 micrograms POP (Cerazette), Etonogestrel 68 mg implant (Nexplanon)Desogestrel 75 micrograms POP daily for 3 monts, followed by etonogestrel 68 mg subdermal implant for following 6 months | Drug | Desogestrel, Etonogestrel |
| Etonogestrel 68 mg subdermal implantEtonogestrel 68 mg subdermal implant for 6 months | Drug | Etonogestrel |
Primary outcome
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
1 secondary outcome
The number of bleeding episodes according to WHO definitions
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dan Apter, Docent principal investigator
VL-Medi Oy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Desogestrel 75 micrograms POP (Cerazette), Etonogestrel 68 mg implant (Nexplanon) and Etonogestrel 68 mg subdermal implant in people with Bleeding, run by VL-Medi Oy at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dan Apter, Docent (+358405550842, dan.apter@vaestoliitto.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2011; AzTrials last refreshed its copy on 2 Nov 2026.