ContraceptionNCT05174195
Does Oral Desogestrel Prior to Insertion of the Etonogestrel Subdermal Implant Improve Continuation Rate at One Year?
A study testing Desogestrel 0.075 milligram and Implanon NXT® subdermal implant in people with Contraception and Progestogen Adverse Reaction, run by University Hospital, Geneva.
Trial summary
Objective: The etonogestrel subdermal implant (ESI) is an effective and safe method of contraception. Although highly efficient, ESI produces often side effects that reduce its tolerance and acceptance. Daily oral desogestrel (DSG) prior to the insertion of ESI might help reduce its premature discontinuation. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception, Progestogen Adverse Reaction
- What is being tested?
- Desogestrel 0.075 milligram and Implanon NXT® subdermal implant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2016to 30 Sep 2019
- Phase
- Interventional
- 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 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women age of 18 - 42 years
- Interested in the use of ESI
- Accepting to have 90 days pre-treatment with OD
- Signed informed consent
Who cannot join
- Pregnancy
- Lactation,
- vaginal bleeding of unknown origin,
- wish to become pregnant,
- weight over 80 kg,
- history of deep vein thrombosis/Pulmanory embolism,
Show all 13Show fewer
- hypertension,
- Diabetes or other metabolic diseases,
- coagulation disorders,
- severe hepatic disorder,
- history of breast/endometrial cancer,
- known hypersensitivity to study drug,
- current treatment with enzyme inducing drugs (e.g.: phenytoin, carbamazepine, phenobarbital, etc.)
About this study
Official title: Can a Three Months Treatment With Oral Desogestrel Prior to Insertion of the Etonogestrel Subdermal Implant Improve Continuation Rate at One Year?
Objective: The etonogestrel subdermal implant (ESI) is an effective and safe method of contraception. Although highly efficient, ESI produces often side effects that reduce its tolerance and acceptance. Daily oral desogestrel (DSG) prior to the insertion of ESI might help reduce its premature discontinuation. Our aim was to evaluate if this pre-treatment increases ESI's tolerance.
Methods: Between 15.08.2016 and 30.09.2019, the investigators conducted a randomized prospective study of women aged 18 to 42 years who were interested to use Implanon and were willing to have 90 days of pre-treatment with DSG, in the family planning clinic of the Geneva University Hospitals and the Hospital of Basel. Women were randomized into either the study ESI only group or to the DSG + ESI group. In the DSG + ESI group, patients were given a 3 months' supply of 75µg of DSG before the insertion of the ESI.
A 3 months visit was pre-programmed for all participants where the bleeding calendar and the questionnaires were collected. All patients were called over the phone after 12 months post ESI insertion in both groups.
Read the detailed description
Study and treatment periods
1 year of patient recruitment 15 months of follow up (90 days OD plus 1 year Implant or 1 year Implant)
Measurements and Procedures:
Assessment of premature ablation (PA) in months 3-12 (ESI only) or 3-15 (OD+ESI). This will require a contact with all patients at 12/15 months to verify if implant is still in place, and if it was removed, why (and possibly to also reassess symptoms).
Women with known PA can be exempted from this follow-up. In case of PA, reasons will be explored and questioned.
- Assessment of symptoms at 3 months only (bleeding calendar and satisfaction questionnaire, see below)
- Assessment of willingness to receive implant at 3 months in OD+ESI group data collection is limited to these items, in order to limit burden on participants, and to focus resources on high quality of data (as opposed to quantity).
- Conditions
- Contraception, Progestogen Adverse Reaction
- Being tested
- Desogestrel 0.075 milligram, Implanon NXT® subdermal implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Desogestrel 0.075 milligramDrug
Also called Implanon NXT® subdermal implant
Inserted after 3 months use of DESOGESTREL
Implanon NXT® subdermal implantDrug
Inserted immediately
| Study group | Role | What they receive |
|---|---|---|
| ESI (Implanon NXT® subdermal implant) | Active comparator | In this group, the implant was inserted immediately after thorough explanations of the potential side effects and possible adverse events Receives: Drug: Implanon NXT® subdermal implant |
| DSG + ESI(Desogestrel +Implanon NXT® subdermal implant) | Experimental | In this group, patients were given a 3 months' supply of 75µg of DSG to be started immediately after which insertion of an ESI was proposed. Similarly, explanations of the potential side effects and possible adverse events were presented to the patient before treatment initiation. Receives: Drug: Desogestrel 0.075 milligram; Drug: Implanon NXT® subdermal implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerance of Implanon
self-reported
Measured: at 1 year after implant insertion (or at ablation)
Secondary outcomes (2)
Discontinuation of implant,
frequency of ablation of any cause and due to intolerance
- severity of specific symptoms at 1 year (or at ablation)
- severity of specific symptoms at 1 year (or at ablation)
Measured: at any time after insertion through study completion, an average of 1 year
specific symptoms
measured by questionnaires on bleeding patterns and satisfaction on a Likert scale
Measured: at 1 year after implant insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2021
- Study start15 Aug 2016
- Primary completion1 Mar 2018
- Study completion30 Sep 2019
Why it stopped: difficult recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized prospective
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michal Yaron, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05174195
- Sponsor's protocol ID
- CCER 16-972
- Status last verified
- Dec 2021
- First submitted
- 29 Jul 2021
- Last updated
- 30 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lombardi Fah V, Catarino R, Castillo S, Badda M, Gezer-Dickschat S, Thieringer F, Tschudin S, Viviano M, Yaron M. Can a 3 months treatment with oral Desogestrel prior to insertion of the etonogestrel-releasing contraceptive implant improve continuation rate at 1 year? A randomized trial. BMC Res Notes. 2023 Mar 13;16(1):35. doi: 10.1186/s13104-023-06304-3.
PubMed 36915205
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can a Three Months Treatment With Oral Desogestrel Prior to Insertion of the Etonogestrel Subdermal Implant Improve Continuation Rate at One Year?
- ClinicalTrials.gov ID
- NCT05174195
- Acronym / sponsor ID
- CCER 16-972
- Conditions
- Contraception, Progestogen Adverse Reaction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficult recruitment
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 15 Aug 2016 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 30 Dec 2021 (actual)
- 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.
Objective: The etonogestrel subdermal implant (ESI) is an effective and safe method of contraception. Although highly efficient, ESI produces often side effects that reduce its tolerance and acceptance. Daily oral desogestrel (DSG) prior to the insertion of ESI might help reduce its premature discontinuation. Our aim was to evaluate if this pre-treatment increases ESI's tolerance.
Methods: Between 15.08.2016 and 30.09.2019, the investigators conducted a randomized prospective study of women aged 18 to 42 years who were interested to use Implanon and were willing to have 90 days of pre-treatment with DSG, in the family planning clinic of the Geneva University Hospitals and the Hospital of Basel. Women were randomized into either the study ESI only group or to the DSG + ESI group. In the DSG + ESI group, patients were given a 3 months' supply of 75µg of DSG before the insertion of the ESI.
A 3 months visit was pre-programmed for all participants where the bleeding calendar and the questionnaires were collected. All patients were called over the phone after 12 months post ESI insertion in both groups.
Detailed description
Study and treatment periods
1 year of patient recruitment 15 months of follow up (90 days OD plus 1 year Implant or 1 year Implant)
Measurements and Procedures:
Assessment of premature ablation (PA) in months 3-12 (ESI only) or 3-15 (OD+ESI). This will require a contact with all patients at 12/15 months to verify if implant is still in place, and if it was removed, why (and possibly to also reassess symptoms).
Women with known PA can be exempted from this follow-up. In case of PA, reasons will be explored and questioned.
- Assessment of symptoms at 3 months only (bleeding calendar and satisfaction questionnaire, see below)
- Assessment of willingness to receive implant at 3 months in OD+ESI group data collection is limited to these items, in order to limit burden on participants, and to focus resources on high quality of data (as opposed to quantity).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized prospective
| Arm | Type | Receives |
|---|---|---|
| ESI (Implanon NXT® subdermal implant) | Active comparator | Drug: Implanon NXT® subdermal implantIn this group, the implant was inserted immediately after thorough explanations of the potential side effects and possible adverse events |
| DSG + ESI(Desogestrel +Implanon NXT® subdermal implant) | Experimental | Drug: Desogestrel 0.075 milligram, Drug: Implanon NXT® subdermal implantIn this group, patients were given a 3 months' supply of 75µg of DSG to be started immediately after which insertion of an ESI was proposed. Similarly, explanations of the potential side effects and possible adverse events were presented to the patient before treatment initiation. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women age of 18 - 42 years
- Interested in the use of ESI
- Accepting to have 90 days pre-treatment with OD
- Signed informed consent
Key exclusion criteria (13 listed)
- Pregnancy
- Lactation,
- vaginal bleeding of unknown origin,
- wish to become pregnant,
- weight over 80 kg,
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 0.075 milligramAlso: Implanon NXT® subdermal implantInserted after 3 months use of DESOGESTREL | Drug | DSG + ESI(Desogestrel +Implanon NXT® subdermal implant) |
| Implanon NXT® subdermal implantInserted immediately | Drug | DSG + ESI(Desogestrel +Implanon NXT® subdermal implant), ESI (Implanon NXT® subdermal implant) |
Primary outcome
Tolerance of Implanon
Time frame: at 1 year after implant insertion (or at ablation)
self-reported
2 secondary outcomes
Discontinuation of implant,
Time frame: at any time after insertion through study completion, an average of 1 year
specific symptoms
Time frame: at 1 year after implant insertion
Results and safety
The study was stopped early (reason given: difficult recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2021.
- Derived from this study: PubMed 36915205Lombardi Fah V, Catarino R, Castillo S, Badda M, Gezer-Dickschat S, Thieringer F, Tschudin S, Viviano M, Yaron M. Can a 3 months treatment with oral Desogestrel prior to insertion of the etonogestrel-releasing contraceptive implant improve continuation rate at 1 year? A randomized trial. BMC Res Notes. 2023 Mar 13;16(1):35. doi: 10.1186/s13104-023-06304-3.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Desogestrel 0.075 milligram and Implanon NXT® subdermal implant in people with Contraception and Progestogen Adverse Reaction, run by University Hospital, Geneva.
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 4 inclusion and 13 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: stopped early, as of the sponsor's last update on 30 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was stopped early (reason given: difficult recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerance of Implanon (time frame: at 1 year after implant insertion (or at ablation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05174195, which also lists 1 linked publication.
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 30 Dec 2021.